Splint Design Research Articles

Designing a placebo device: involving service users in clinical trial design

BackgroundService users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported.AimsTo enhance the design of a future clinical trial of hand splints for thumb‐base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process.DesignTwo fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb‐base OA were approached about involvement by Occupational Therapy (OT) practitioners.Content of the foraA total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group (‘arm’) was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint.Conclusion and discussionThis is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability.

Finite Element Analysis of Stress Distribution with Splinted and Nonsplinted Maxillary Anterior Fixed Prostheses Supported by Zirconia or Titanium Implants

The aim of the present study was to evaluate the effect of splinting titanium (Ti) or zirconia (Zr) implants supporting maxillary anterior fixed prostheses on the stress levels and patterns in the implants, prostheses, and the surrounding bone; and to compare the effects of Zr and Ti implant materials on the stress distribution in splinted and nonsplinted designs via finite element modeling. Zr and Ti dental implants and the anterior maxilla were modeled. In the nonsplinted design (D1), implants were placed into the maxillary left central incisor and canine regions, and a three-unit zirconia fixed prosthesis was modeled. In the splinted design (D2), a symmetric model of D1 was generated and the two prostheses were splinted together to create a six-unit prosthesis. Loading was applied horizontally and obliquely. Von Mises, tensile, and compressive stresses were evaluated in the implants, prostheses, and surrounding bone. Under both loading conditions, the stresses on the D2 implants were lower than those in the D1 implants. Stresses were concentrated on the neck of the implant and decreased through the apex. All of the stress values in cortical bone in D1 were slightly higher than in D2 for both implant materials under both loading conditions. When the implants were splinted together, stresses were reduced in the supporting bone and implants in both loading conditions, but increased stress was observed in the prostheses under oblique loading. Intense stress concentrations were found in the connector of the splinted prosthesis and the cervical region of the nonsplinted prosthesis. Zr and Ti implants showed very similar stress distributions in all materials. Under oblique loading, lower stresses occurred in implants and the prosthesis core material when Ti implants were used.

Poster 37: Is Virtual Surgical Planning in Orthognathic Surgery Error Proof?

The advent of virtual surgical planning (VSP) represents a fundamental shift in the work-up of orthognathic and reconstructive maxillofacial surgery cases. VSP utilizes computer assisted design-computer assisted modeling (CAD-CAM), and gives the surgeon the ability to make complex spatial changes on a virtual platform instead of a lab bench. This technology allows design and fabrication of an intermediate splint which in the past required cumbersome model surgery to control precise movements in yaw, pitch, and roll. The use of VSP for orthognathic surgery is described in the literature1,2, however, there are few studies comparing the precision of VSP movements with those previously performed with plaster models and articulators. This study is an analysis of error achieved with VSP for orthognathic surgery.

Splinting for carpal tunnel syndrome.

Carpal tunnel syndrome (CTS) is a condition where one of two main nerves in the wrist is compressed, which can lead to pain in the hand, wrist and sometimes arm, and numbness and tingling in the thumb, index and long finger. Splinting is usually offered to people with mild to moderate symptoms. However, the effectiveness and duration of the benefit of splinting for this condition remain unknown. To compare the effectiveness of splinting for carpal tunnel syndrome with no treatment, placebo or another non-surgical intervention. We searched the Cochrane Neuromuscular Disease Group Specialized Register (10 January 2011), CENTRAL, NHSEED and DARE (The Cochrane Library 2011, Issue 4), MEDLINE (January 1966 to December 2011), EMBASE (January 1980 to January 2012), AMED (January 1985 to January 2012), and CINAHL Plus (January 1937 to January 2012), using no time limits. We searched the reference lists of all included trials and relevant reviews for further relevant studies. All randomised and quasi-randomised trials comparing splinting with no treatment (or a placebo) or with other non-surgical treatments were eligible for inclusion. We also included studies comparing one splint type or regimen versus another. We excluded studies comparing splinting with surgical treatment. There were no language restrictions. We included all patients diagnosed with carpal tunnel syndrome unless they had undergone surgical release. Two review authors independently selected trials for inclusion, and performed data extraction. Two authors also independently performed the assessment of risk of bias. We calculated measures of effect as risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI) reported and statistical significance set at P < 0.05 for all outcome comparisons. The review included 19 studies randomising 1190 participants with carpal tunnel syndrome. Two studies compared splinting with no treatment, five compared different splint designs, one compared different splint-wearing regimens, seven compared splint delivered as a single intervention with another non-surgical intervention, and five compared splint delivered alongside other non-surgical interventions with another non-surgical intervention. Only three studies reported concealing the allocation sequence, and only one reported blinding of participants. Three studies measured the primary outcome, short-term overall improvement at three months or less. One low quality study with 80 wrists found that compared to no treatment, splints worn at night more than tripled the likelihood of reporting overall improvement at the end of four weeks of treatment (RR 3.86, 95% CI 2.29 to 6.51). However, the lack of patient blinding and unclear allocation concealment suggests this result should be interpreted with caution. A very low quality quasi-randomised trial with 90 wrists found that wearing a neutral splint more than doubled the likelihood of reporting 'a lot or complete relief' at the end of two weeks of treatment compared with an extension splint (RR 2.43, 95% CI 1.12 to 5.28). The third study which measured short-term overall improvement did not report outcome data separately per group. Nine studies measured adverse effects of splinting and all found either no or few participants reporting discomfort or swelling due to splinting; however, the precision of all RRs was very low. Differences between groups in the secondary outcomes - symptoms, function, and neurophysiologic parameters - were most commonly small with 95% CIs incorporating effects in either direction. Overall, there is limited evidence that a splint worn at night is more effective than no treatment in the short term, but there is insufficient evidence regarding the effectiveness and safety of one splint design or wearing regimen over others, and of splint over other non-surgical interventions for CTS. More research is needed on the long-term effects of this intervention for CTS.

A novel design of a computer-generated splint for vertical repositioning of the maxilla after Le Fort I osteotomy

The objective of this study was to evaluate the efficacy of a novel tooth/bony-supported virtual splint design to control the maxillary vertical, rotational, and anteroposterior intraoperative movements. A tooth/bone-borne splint was designed to position the osteotomized maxilla intraoperatively. Lateral cephalometric radiographs were obtained 1 week before the operation and 1 week after to compare the planned and actual movements of the maxilla. The paired t test showed no significant difference between the planned and actual movements in both the vertical and horizontal measurements (P ≤ .05). The difference between the planned and actual horizontal movements in 4 (66.7%) of the 6 patients was 1 mm or less. For the vertical movements, 5 (83.3%) of the 6 patients showed a difference equal to or less than 1 mm. The 2-piece surgical stent showed accurate control on the osteotomized maxilla and succeeded its repositioning to the preplanned positions.

Computer-assisted orthognathic surgery: feasibility study using multiple CAD/CAM surgical splints

We present a virtual planning protocol incorporating a patented 3-surgical splint technique for orthognathic surgery. The purpose of this investigation was to demonstrate the feasibility and validity of the method in vivo. The protocol consisted of (1) computed tomography (CT) or cone-beam computed tomography (CBCT) maxillofacial imaging, optical scan of articulated dental study models, segmentation, and fusion; (2) diagnosis and virtual treatment planning; (3) computed-assisted design and manufacture (CAD/CAM) of the surgical splints; and (4) intraoperative surgical transfer. Validation of the accuracy of the technique was investigated by applying the protocol to 8 adult class III patients treated with bimaxillary osteotomies. The virtual plan was compared with the postoperative surgical result using image fusion of CT/CBCT dataset by analysis of measurements between hard and soft tissue landmarks relative to reference planes. The virtual planning approach showed clinically acceptable precision for the position of the maxilla (<0.23 mm) and condyle (<0.19 mm), marginal precision for the mandible (<0.33 mm), and low precision for the soft tissue (<2.52 mm). Virtual diagnosis, planning, and use of a patented CAD/CAM surgical splint technique provides a reliable method that may offer an alternate approach to the use of arbitrary splints and 2-dimensional planning.

A comparative analysis of the accuracy of different direct impression techniques for multiple implants

The aim of this study was to compare the accuracy of different direct implant impression techniques for edentulous arches with multiple implants. Five experimental groups (n = 5) were assembled. Experimental models were created by a direct splinted technique (EG2 to EG5) and a non-splinted technique (EG1). In EG2 and EG3 synOcta impression copings were splinted with an acrylic resin bar, and in EG4 and EG5 with a light-curing composite resin bar. In EG3 and EG5 the resin bars were sectioned, while the other experimental groups were not. Three-dimensional discrepancies were measured by a computerized coordinate measuring machine. Distortion values among the groups were analysed using one-way repeated measures ANOVA. The post hoc Tukey's test was then performed for multiple comparisons. The highest accuracy was obtained in EG2 (mean deviation: 12.70 μm). The acrylic bars demonstrated less deviation (12.70 μm and 22.71 μm) from the master model than the light-curing composite resin groups and the non-splinted group (41.09 μm). The post hoc Tukey's test showed no significant difference among the groups when the effect of splint design on accuracy was investigated. For situations where impressions of multiple implants are to be made, splinting impression copings with acrylic resin demonstrate superior results than the non-splinted technique and splinting with light-curing composite.

A Novel Splint for Proximal Interphalangeal Joint Contractures: A Case Report

Wollstein R, Rodgers J, Ogden T, Loeffler J, Pearlman J. A novel splint for proximal interphalangeal joint contractures: a case report.Proximal interphalangeal (PIP) joint contractures are notoriously difficult to treat. Best results are obtained with early mobilization and splinting, though a high level of adherence is critical for a good outcome. A new roll-on splint that aims to increase motion with minimal difficulty was used. The patient described here with moderate PIP joint contractures (30°–60°) was treated successfully using this splint. The splint design and therapy protocol are described. The patient was treated for 12 weeks with good adherence to therapy and splinting. Total active motion increased by 87% in the index finger and 108% in the ring finger. Grip, pinch, and tip-pinch strengths increased. The Disabilities of the Arm, Shoulder and Hand score improved from 26.7% to 2.5%. At 3 months, the patient returned to work. Though this case illustrates some of the advantages and disadvantages of the new splint, further study is necessary to evaluate the splint and compare it with other existing forms of treatment for PIP joint contractures.

Novel Splint Allowing Concurrent Midface and Occlusal Control During Orotracheal Intubation

Occlusal splints are used in craniomaxillofacial surgery to control the dental-bearing bony structures of the midface and mandible. They are created to guide the mobile bone segments into position based on the ideal or planned dental and facial relationships. For conventional orthognathic cases and maxillofacial trauma scenarios involving the dentition, a nasal endotracheal tube is required, allowing the teeth to be closed into intermaxillary fixation. However, in situations where access to the nasal cavity is required, such as concurrent rhinoplasty, or when higher osteotomies involving the midface are performed requiring advancement or manipulation of the nasal region, the nasal tube needs to be converted into an oral tube (J Clin Anesth 2011;23:342). This requires time and inconvenience and is a potentially dangerous maneuver in the setting of existing surgical edema, fluids, and manipulation. We report on a novel oral splint design allowing for both intermaxillary fixation to be established using an oral endotracheal tube while allowing for manipulation of the midface via the nasal cavity and not requiring a tube change intraoperatively.

Usefulness of occlusal splints

Dentists often use occlusal splints in the management of occlusodontic problems. Because they are considered to provide non-invasive and reversible treatment they are therapeutic devices that conform well to the current philosophy governing protocols for therapy of the masticatory system. Proper design and placement of occlusal splints requires that they respond to precise indications and that practitioners fabricate and maintain them with scrupulous care to assure that patients benefit from them. Splints help practitioners adjust the relationship between the jaws either by suppressing blockage of teeth to relax muscles or by repositioning the condyles in the articular fossas to recapture discs or to reduce painful excess intra-articular pressure derived from degenerative diseases.Occlusal splints are also suitable as diagnostic tools to validate and evaluate contributions of behavioral, postural, and psychosocial factors to the multifactorial etiology of malfunctions of the masticatory apparatus. The simple introduction into a patient’s mouth of an appliance whose benefits have been well described to that patient will serve as a forward step in the psychological management of a TMD problem, especially if bruxism is one of its components.

Changes in Condylar Position Using Different Types of Splints With and Without a Chinstrap: A Case-Control Study

The aim of this case-control study was to analyze and quantify if there is a different mechanical effect of stabilization and pivot splints with uni- or bilateral pivot of different heights and with and without an additional chinstrap, on the vertical, sagittal, and horizontal condyle position. A stabilization splint and splints with unilateral or bilateral posterior pivot support of 0.6 mm or 1.9 mm height were used with and without a chinstrap individually adjusted to 5N per side. Electronic-condylar-positionanalysis was performed using an ultrasound-based jaw-tracking system with an accuracy of 0.1 mm. Manual guided central position served as the reference point. Participants were 40 functional, asymptomatic volunteers with a mean age of 33.9 years. Main effect splint design (stabilization, uni-, bilateral pivot) was not significant. Pivoting height was reported as significant (p≤00.02) in all axes. Use of the chinstrap was significant (p≤0.03) in the X- and Y- axis, but not significant in the Z-axis. A post-hoc test revealed that use of a chinstrap led to significantly (p=0.003) less anterior and significantly (p=0.002) more inferior condyle displacement. Results indicate that the use of pivot splints only in combination with a chinstrap lead to a distractive effect of the condyles.

Trigger Finger Treatment: A Comparison of 2 Splint Designs

To compare the effectiveness of 2 splint designs in treating trigger finger. This prospective, randomized study of 30 subjects evaluated splinting efficacy for trigger finger, comparing 2 splint designs: a custom metacarpophalangeal (MCP) joint blocking splint and a distal interphalangeal (DIP) joint blocking splint. We evaluated range of motion, grip strength, severity and frequency of triggering, functional impact, and performance measure scores. Subjects recorded frequency of splint use, splint comfort, and functional impact of the splint. We undertook statistical analysis of splint effectiveness before and after treatment and of differences between the 2 splint groups. We evaluated qualitative data to identify trends in subjective preference toward splint design. Both groups showed quick and significant improvement of triggering; however, the MCP joint blocking splint was successful in providing at least partial relief of triggering and pain in 10 of 13 trigger finger subjects, whereas the DIP joint blocking splint provided at least partial relief of triggering and pain in 7 of 15 subjects after 6 weeks of treatment. Data showed statistically significant improvement in both groups at 6 weeks, which was maintained in a minority of the cohort for 1 year. There was little difference between the 2 splint groups for impact on function. Subjects who wore the MCP joint blocking splint reported higher rates of comfort compared with those who wore the DIP joint blocking splint. Subject comfort with the MCP joint blocking splint allowed for longer periods of usage. Selection of a splint design depends on clinical presentation, vocation, and leisure activities. Initiating conservative treatment with the MCP joint blocking splint has value for patients with trigger finger and positive outcomes in 77% of subjects, whereas use of the DIP joint splint was effective in about half of subjects. Therapeutic I.

Early return to work and improved range of motion with modified relative motion splinting: a retrospective comparison with immobilization splinting for zones V and VI extensor tendon repairs

Introduction There is a lack of evidence on the best method for rehabilitating extensor tendon injuries in zones V and VI. The purpose of this study was to evaluate the outcomes of modified relative motion splinting compared with immobilization following repair of extensor tendons in zones V and VI. Methods A retrospective analysis compared the outcomes of relative motion splinting with immobilization. Sixteen patients (16 fingers) were treated by conventional immobilization splinting for four weeks (immobilization group) followed by mobilization with avoidance of ‘at-risk/heavy’ activities for a further 4–6 weeks. Twenty-three patients (23 fingers) were treated with the modified relative motion splint (mRMS group) during the day and a resting splint worn overnight for the first four weeks. The relative motion splint was continued for ‘at-risk/heavy’ activities for a further 4–6 weeks. Results The mRMS group demonstrated statistically significant improvement in range of motion compared with the immobilization group. This effect was most marked at six weeks ( P = 0.0194, two-way mixed ANOVA) with the mRMS group achieving a 12% higher mean percentage total active motion ( P = 0.0076, Mann-Whitney U test). Results were similar for both groups 12 weeks postoperatively. Differences in return to work times between groups were statistically significant ( P = 0.0062, Mann-Whitney U test). Average return to work was 9.4 weeks for the immobilization group and 3.3 weeks for the mRMS group, equating to a 42 days earlier return to work for the mRMS group. There was no incidence of tendon rupture in either group. Conclusion This study demonstrates that modified relative motion splintage (finger based without wrist component) can be applied in the postoperative management of single zone V or VI extensor tendon repairs. The main advantages of this protocol, compared with immobilization include the small simple splint design, and straightforward patient instructions that enable earlier mobilization, functional hand use and return to both daily living and work.

Systematic review of design and effects of splints and exercise programs in hand osteoarthritis

To describe and evaluate the design and effects of splints and exercise programs in hand osteoarthritis. Controlled trials identified through systematic literature reviews were included. Design of splints and exercise programs were evaluated according to existing recommendations and classification systems. The risk of bias was assessed by 2 independent reviewers and effects were summarized descriptively or by meta-analyses. Twelve trials were included in the review: 7 assessed the effect of splints, 3 the effect of exercises, and 2 a combination of splints and exercises. The results revealed a great variety in the design of splint and exercise programs. A meta-analysis of the 2 randomized trials with low risk of bias demonstrated that splints significantly reduced hand pain at short-term (<3 months) and long-term (≥3 months) followup, with a standardized mean difference of 0.37 (95% confidence interval [95% CI] 0.03, 0.71) and 0.80 (95% CI 0.45, 1.15), respectively. Further, results from single trials indicated that hand exercises may reduce pain and increase range of motion and strength, while a combination of splints and daily exercises may reduce pain and stiffness and improve function. There is consistent evidence that splints reduce hand pain, but limited evidence for the effects of hand exercises and a combination of hand exercises and splints in hand osteoarthritis.

Comparison of Two Carpometacarpal Stabilizing Splints for Individuals with Thumb Osteoarthritis

Splinting the thumb in carpometacarpal osteoarthritis (CMC OA) is a common practice; however, research evidence is lacking to support the use of one specific splint design. The purpose of the study was to compare the effect of two different splints on hand function, pain, and hand strength in adults with CMC OA. Fifty-six participants were assigned randomly to splint order in a two-phase, four-week crossover trial. Hand function, the primary outcome, was assessed using the Australian Canadian Hand Osteoarthritis Hand Index. Differences between the two splints were not statistically significant for effect on hand function, and grip and pinch strength. However, the custom-made splint showed a greater average reduction in pain scores. Both splints demonstrated modest improvements in hand function. The prefabricated splint was the preferred splint although the custom-made splint decreased pain slightly more. This reinforces the client-centered approach to splinting. Level of Evidence 2b.

Treatment Options for Mallet Finger: A Review

Mallet finger is a common injury. The aim of this review is to give an overview of the different treatment options of mallet injuries and their indications, outcomes, and potential complications. A literature-based study was conducted using the PubMed database comprising world literature from January of 1980 until January of 2010. The following search terms were used: "mallet" and "finger." There are many variations in the design of splints; there are, however, only a few studies that compare the type of splints with one another. Splinting appears to be effective in uncomplicated and complicated cases. Equal results have been reported for early and delayed splinting therapy. To internally fixate a mallet finger, many different techniques have been reported; however, none of these studies examined their comparisons in a controlled setting. In chronic mallet injuries, a tenodermodesis followed by splinting or a tenotomy of the central slip is usually performed. If pain and impairment persist despite previous surgical corrective attempts, an arthrodesis of the distal interphalangeal joint should be performed. Uncomplicated cases of mallet injuries are best treated by splinting therapy; cases that do not react to splinting therapy are best treated by surgical interventions. Controversy remains about whether mallet injuries with a larger dislocated bone fragment are best treated by surgery or by external splinting.

Tailoring Nasal Splints to Optimize Rhinoplasty Results

Sir: No rhinoplasty surgeon would deny the contributions of nasal splinting in this challenging surgery. It can help to stabilize structures, thus reducing edema and improving remodeling appearances. Although many masters in this field have emphasized this step and introduced commodities off the shelf, better results could be achieved if nasal splints could be tailored to fit different cases. Over the past 2 years, partly because of economic considerations, we have chosen to fashion nasal splints ourselves for our patients. This has proved to be a simple and effective tip that is worth sharing. In the preparation process, empty alloy cans were collected. We selected those that were stronger than aluminum cola cans, softer than lead pots, with good flexibility, and with a smooth surface. The entire body was cut into one metal plate and then thoroughly cleaned and sterilized. A broad, cloth tape was placed on one side of the metal plate for standby. Then, a reel of double-sided adhesive foam was prepared—the senior author used items found easily in supermarkets and hardware stores, including a sewing scissors, pliers, ballpoint pen, and ruler in the operating room for tailoring (Fig. 1).Fig. 1.: Materials and splints.At the end of each rhinoplasty operation, after all incisions have been closed and before the patient has left the operating room, 5 minutes is spent tailoring the splint. First, the distance between the radix point and the anterior angle of the septum to be the height of an isosceles trapezoid-shaped splint is measured. Then, each projection (upper projection and lower projection) and the width between two dorsum aesthetic lines (upper width and lower width) are measured carefully on these two points to plan the upper and lower edges of the trapezoid. Finally, we can draw an isosceles trapezoid on the cloth tape/metal plate composite with its bottom edge being as long as doubled lower projection plus lower width; the upper edge is doubled upper projection plus upper width and its height equal to the height of an isosceles trapezoid-shaped splint (Fig. 2). The scissors is used to cut the trapezoid off the plate and blunt four angles into an arc form, making sure that there is no barb on any of the edges. With the help of a long straight pliers, it can easily be angled along the dorsum aesthetic lines on the splint. After trying it on the patient's nose and determining that it is satisfactory, we can fix it on the patient's nose with the double-sided adhesive foam to finish the work.Fig. 2.: Splint design: UP, upper projection; UW, upper width; LP, lower projection; LW, lower width; H, height of an isosceles trapezoid-shaped splint.In our experience, the tailoring splint can replace those commodities, be used repeatedly on the same patient, and be adjusted at the surgeon's will. It costs only 5 minutes and almost no money to make a new one whenever we need it. We can even teach patients to do it themselves in the kitchen, which is often helpful for nonlocal patients. Generally, tailoring splints can save money and time, save patients and surgeons sometimes, and always save the earth. Zhanqiang Li, M.D. Yongxue Xie, M.D. Qinjian Peng, M.D. Lin Liu, M.D. Bo Yu, M.D. Beijing Huangsi Aesthetical Surgery Hospital Beijing, People's Republic of China

Design of splints based on the NiTi alloy for the correction of joint deformities in the fingers.

BackgroundThe proximal interphalange joint (PIP) is fundamental for the functional nature of the hand. The contracture in flexion of the PIP, secondary to traumatisms or illnesses leads to an important functional loss. The use of correcting splints is the common procedure for treating this problem. Its functioning is based on the application of a small load and a prolonged stress which can be dynamic, static progressive or static serial.It is important that the therapist has a splint available which can release a constant and sufficient force to correct the contracture in flexion. Nowadays NiTi is commonly used in bio-engineering, due to its superelastical characteristics. The experience of the authors in the design of other devices based on the NiTi alloy, makes it possible to carry out a new design in this work - the production of a finger splint for the treatment of the contracture in flexion of the PIP joint.MethodsCommercial orthosis have been characterized using a universal INSTRON 5565 machine. A computational simulation of the proposed design has been conducted, reproducing its performance and using a model "ad hoc" for the NiTi material. Once the parameters have been adjusted, the design is validated using the same type of test as those carried out on commercial orthosis.Results and DiscussionFor commercial splint the recovering force falls to excessively low values as the angle increases. Angle curves for different lengths and thicknesses of the proposed design have been obtained, with a practically constant recovering force value over a wide range of angles that vary between 30° and 150° in every case. Then the whole treatment is possible with only one splint, and without the need of progressive replacements as the joint recovers.ConclusionsA new model of splint based on NiTi alloy has been designed, simulated and tested comparing its behaviour with two of the most regularly used splints. Its uses is recommended instead of other dynamic orthosis used in orthopaedics for the PIP joint. Besides, its extremely simple design, makes its manufacture and use on the part of the specialist easier.

Randomised cross-over study of oral appliances for snoring

To compare a mandibular advancement splint to a control bite raising appliance in the treatment of snoring with or without mild obstructive sleep apnoea syndrome. A prospective two-treatment randomised cross-over clinical trial. Single centre secondary care Dental Hospital. Fifty-two subjects (36 men, 16 women) diagnosed with non-apnoeic snoring or mild obstructive sleep apnoea syndrome (apnoea/hypopnoea index < or =15 events/h), were recruited from Departments of Respiratory Medicine and ENT surgery, Newcastle upon Tyne Hospitals NHS Foundation Trust. The Snoring Symptoms Inventory questionnaire (SSI) and the Epworth Sleepiness Score (ESS) were used to evaluate changes in symptoms. Patient reported outcomes (compliance, adverse events, splint preference) were recorded by questionnaire. Subjects attended for five study visits and used a mandibular advancement splint and a bite raising appliance at home each for 4 weeks, with a 3-week washout period between devices. Thirty-eight subjects completed the study. Both the mandibular advancement splint and bite raising appliance significantly reduced the SSI compared to the baseline scores: mandibular advancement splint 5.5, P = 0.013; bite raising appliance 3.1, P = 0.005. No statistically significant difference between the two treatment periods was detected (P > 0.05). The reduction in the Epworth Sleepiness Score was: mandibular advancement splint 1.0, P = 0.02; bite raising appliance 0.3, P = 0.4. The change in the Epworth Sleepiness Score was not statistically significantly different between the mandibular advancement splint and bite raising appliance treatment periods (P > 0.05). In this cohort of patients diagnosed with snoring +/- mild OSA: 1 both the mandibular advancement splint and bite raising appliance designs of splint appeared to reduce the symptoms of snoring; 2 no difference in the magnitude of this effect was detected in favour of one design of splint.

The use of intraoral splints: a case report

Intraoral splints are frequently used in dentistry and seem to be widely accepted as therapeutical strategies. This implies that the therapeutical mechanism and the treatment effects are well known and understood. Recently published reviews on oral splints determined that the quality of the evidence supporting the mechanisms of action of oral splints is still questionable. The initial therapy of a patient with craniomandibular disorder and reciprocal clicking in the right temporo-mandibular joint is described in detail in this paper. The treatment modalities and the measurements used to judge and to evaluate the treatment effect are provided. The therapeutical concept for this patient was not based on a particular splint design. An individual targeted therapeutical strategy was implemented instead. Splint strategies and splint prescription habits have to be reconsidered. In medicine, a strong trend towards individual therapeutical concepts can be observed. The term "target therapy concept" is used to describe the individual patient-orientated therapeutical demands. In splint concept, these individualized strategies are still not implemented. Using such individualized splint concept in clinical trials is, maybe, a key to improve the external, scientific evidence on this particular topic.