Demineralized Bovine Bone Mineral Research Articles

Alveolar ridge alterations after lateral GBR with and withouthyaluronic acid (xHyA) - a prospective randomized trial withmorphometric and histomorphometric evaluation.

To clinically and histologically evaluate the potential effect of a cross-linked high molecular weight hyaluronic acid (xHyA) on the outcomes of guided bone regeneration (GBR) performed with a demineralized bovine bone mineral (DBBM) covered with a natural collagen membrane (NCM). Eleven patients (eight females and three males, mean age 53 years) with a total of 27 surgical sites were treated. Treatments were performed with either DBBM and NCM fixated with tacks (group A) or DBBM mixed with xHyA and subsequently covered with NCM (group B). Clinical evaluations were made at Baseline (T1), immediately after GBR (T2) and at the time of implant placement (T3). Additionally, at the time of implant placement, core biopsies were retrieved and submitted for histological analysis. Healing was uneventful in all cases. At six months, group B revealed a statistically significantly higher crestal ridge dimension compared to group A (P=0.007). The histologic analysis revealed a tendency for higher mineralized tissue formation in group B compared to group A (i.e., 67.5% versus 41.6%) and contained a higher amount of new bone (37.2%) and less DBBM residues (20.9%) than group A (i.e., 12.8% new bone and 28.8% DBBM residues, respectively). Within their limits, the present data indicate that, during GBR with NCM, the combination of DBBM and xHyA may improve the quality and quantity of bone formed with DBBM alone.

Evaluation of the clinical and radiographic effectiveness of treating peri-implant bone defects with a new biphasic calcium phosphate bone graft: a prospective, multicenter randomized controlled trial.

Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 40% β-TCP and 60% HA compared to demineralized bovine bone mineral (DBBM). This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ² test. Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM. Clinical Research Information Service Identifier: KCT0006428.

Peri-implant tissue changes at sites treated with alveolar ridge preservation in the aesthetic zone: Twenty-two months follow-up of a randomized clinical trial.

To compare tissue changes at implant sites previously treated with two biomaterials for alveolar ridge preservation (ARP) in the aesthetic zone, 1 year after restoration. Sixty-six participants were treated with ARP using demineralized bovine bone mineral (DBBM) or DBBM +10% of collagen (DBBM-C), both covered with a collagen matrix (CM). Dental implants were placed, and definitive crowns were installed. Silicon impressions were taken before tooth extraction (T0), 2 weeks after crown insertion (T1) and 1 year after restoration (T2). Mid-facial mucosal level change (MLC), soft tissue thickness changes (TT), and marginal bone loss (MBL) were analysed using inter-group comparisons. Fifty-four participants were included in the analysis. The mid-facial level change between T0-T1 and T1-T2 showed no statistical difference between DBBM and DBBM-C. Between T0 and T1 for soft tissue thickness, DBBM performed significantly better at 3 and 5 mm below the mucosal margin. From T1 to T2, no significant differences between groups were found at any level for soft tissue thickness and MBL. At the aesthetic zone, advanced recession from tooth extraction to crown placement can be expected at sites treated with ARP regardless of biomaterial used. However, after crown insertion, tissue stability can be predicted.

Variations in Soft and Hard Tissues following Immediate Implant Placement versus Delayed Implant Placement following Socket Preservation in the Maxillary Esthetic Region: A Randomized Controlled Clinical Trial.

Introduction Although retrospective analysis has shown immediate placement of implants (IIP) in the maxillary esthetic zone showing promising outcomes compared to delayed placement of implants following socket preservation (DIP), a direct comparison in a prospective, well-designed randomized fashion with adequate power analysis between the two implant placement protocols is still lacking. This study is aimed at radiographically evaluating the effect of IIP after extraction as compared to implant placed in preserved sockets 4 months following extraction (DIP) in terms of changes in buccal plate thickness(CBT) after 6 months of healing and evaluation of pink esthetic score (PES) for assessment of soft tissue changes and patient-related outcome measures (PROMs) using visual analogue scale (VAS). Materials and Methods 25 implants were placed immediately following extraction in the IIP group, and 25 implants were placed four months following socket preservation with demineralized bovine bone mineral (DBBM) and advanced platelet-rich fibrin (A-PRF) in the DIP group, control group, in the maxillary esthetic region. CBCT was taken preoperatively and 6 months postoperatively to assess the dimensional changes in the buccal bone plates(CBT). PES and PROMs for pain threshold and patient satisfaction using VAS were evaluated at the time of implant placement and 6 months postoperatively. Results Significant differences in mean reduction in buccal plate thickness (CBT) were found in the test group (IIP) 0.2 ± 0.02 compared to the control group (DIP) which showed a mean reduction in CBT of 0.4 ± 0.1 (p < 0.001) at the end of 6 months. Although there was no statistically significant difference in PES between the groups, there was a significant difference between the groups when individual values of PES were compared at p < 0.001. Conclusion The IIP group showed lesser reduction in CBT and a better PES which is an important clinical information which could be translated clinically in situations where implant placement is planned in the maxillary esthetic region. This trial is registered with CTRI/2019/06/019723.

Immediate Implant Placement in Maxillary Esthetic Zone without Augmenting the Jumping Gap versus the Use of Autogenous Bone Particulates or Demineralized Bovine Bone Graft (Randomized Clinical Trial)

Aim: to assess Immediate Implant Placement in Maxillary Esthetic Zone without Augmenting the Jumping Gap versus the Use of Autogenous Bone Particulates or Demineralized Bovine Bone Graft. Material and Methods: This was a Randomized parallel controlled clinical trial conducted on 30 implant sites that indicated immediate implant placement in the maxillary esthetic zone divided into 3 groups equally: In group (A): immediate implants were inserted in the esthetic maxillary zone with no graft in the jumping gap. In group (B): immediate implants were inserted in the esthetic maxillary zone with demineralized bovine bone mineral (DBBM) in the jumping gap. In group (C): immediate implants were inserted in the esthetic maxillary zone with autogenous bone graft in the jumping gap. CBCT scans were performed immediately after the surgery and 6 months later for measuring horizontal bone changes at 3 levels (platform, mid implant, and apex level) of the labial plate of the bone and vertical bone changes labial and palatal plate of bone. Results: The mean horizontal bone loss at platform level was 1.57±0.283mm, 0.845±0.167 mm, and 1.226 mm at groups A (graft less group), B (xenograft group), and C (autogenous group) respectively. While at mean mid implant level was 1.155±0.3 mm,0.754±0.185 mm, and 0.829±0.31 mm at group A (graft less group), B (xenograft group) & C (autogenous group) respectively. Conclusion: the use of DBBM as a graft in the jumping gap showed the least bone dimensional changes compared to no graft and autogenous bone graft group in immediate implant placement.

Alveolar ridge dimensional changes after two socket sealing techniques. A pilot randomized clinical trial.

This pilot study aimed to assess dimensional changes following two different alveolar socket sealing techniques. Twenty-one patients requiring tooth extraction and implant placement were randomly allocated to two different alveolar ridge preservation techniques. In the control group, demineralized bovine bone mineral (DBBM) and a gingival soft tissue punch were used to fill and seal the socket, whereas in the test group, the extraction socket was filled with DBBM and sealed with a hemostatic gelatin sponge. Digitalized impressions were taken before and 6months after tooth extraction. The comparison was made on horizontal and vertical dimensional changes. The mean vertical loss was 0.8 ± 0.6mm for the control group and 0.7 ± 0.5mm for the test one. No statistical difference was found between groups for the vertical shrinkage. The horizontal dimensional narrowing of the alveolar socket was respectively 7.1/4.0/2.5mm at levels 1, 3, and 5mm from a coronal reference level for the control group. The test group showed dimensional changes of 4.8/2.3/1.3mm at the three different levels, respectively. A significant difference was found at levels 3 and 5mm. Referring to a visual analog pain scale, patients reported more severe pain in the control group (5.7/10) when compared with the test group (2.8/10). The difference was statistically highly significant (P ≤ 0.001). A significant difference was found between control and test groups regarding the horizontal dimensional changes and the post-operative pain. Regarding this primary result, the socket sealing technique with a hemostatic sponge provides an effective and inexpensive protocol with less post-operative pain.

Deproteinized bovine bone mineral is non‐inferior to deproteinized bovine bone mineral with 10% collagen in maintaining the soft tissue contour post‐extraction: A randomized trial

To test the non-inferiority of demineralized bovine bone mineral (DBBM) compared to demineralized bovine bone mineral with 10% collagen (DBBM-C) for the maintenance of the soft tissue contour after tooth extraction in the esthetic zone. Sixty-five patients randomly received ridge preservation at a single site in the anterior maxilla with DBBM or DBBM-C. Both, DBBM and DBBM-C, were covered with a collagen matrix. Profilometric analyses were performed at baseline (BL), immediately after treatment (PO), and at 4months (FU; day of implant placement). The main outcome was the horizontal mean change (HC) at the buccal aspect. The measurements also included changes of the estimated soft tissue thickness (eTT) at 1, 3, and 5mm below the buccal gingival margin. Descriptive analysis was performed, and differences between groups were analyzed using independent samples t test. The non-inferiority test was performed for HC. At 4months, the horizontal mean change (HC) was -1.43mm (±0.53mm) (DBBM-C) and -1.32mm (±0.53mm) (DBBM). Change of the estimated soft tissue thickness (eTT) between baseline (BL) and four months of follow-up (FU) at 1, 3, and 5mm amounted to -4.58mm (±2.02mm), -2.40mm (±0.97mm), and -1.37mm (±0.78mm) for DBBM-C and to -4.12mm (±1.80mm), -2.09mm (±0.91mm), and -1.23mm (±0.72mm) for DBBM. The differences between the groups were not statistically significantly for any of the outcome measures (p>.05). DBBM is non-inferior to DBBM-C for the maintenance of the soft tissue contour 4months after tooth extraction.

A new standardized critical size bone defect model in the pig forehead for comparative testing of bone regeneration materials

The preclinical study aimed to establish a standardized preclinical model to investigate osseous graft consolidation in defect configurations of limited regenerative capacity. Critical size defects (CSD) were prepared and titanium tubes inserted for defect separation from local bone in the forehead area of 18 pigs. Defects were filled with demineralized bovine bone mineral (DBBM) or served as empty controls and were covered with a resorbable collagen membrane (CM) or left untreated. Six randomly selected pigs were sacrificed after 4, 8 and 12weeks. Specimens were histologically and histomorphometrically analysed focusing on newly formed bone (NFB), demineralized bovine bone mineral (DBBM) and soft tissue (ST) proportions. Four weeks after defect preparation, no statistically significant difference concerning NFB quantity could be detected within the groups. Defects covered with the CM showed lower amounts of DBBM. After 6 and 12weeks, defects augmented with DBBM in combination with a CM (8weeks: 43.12 ± 4.31; 12weeks: 43.05 ± 3.01) showed a statistically significant higher NFB rate compared to empty control defects covered with 8weeks: 7.66 ± 0.59; 12weeks or without a CM; 8weeks: 8.62 ± 2.66; 12weeks: 18.40 ± 2.40. CM application showed no significant impact on osseous defect regeneration or soft tissue formation. Superior NFB could be detected for basal aspect for several evaluation time points. The modification of CSD with titanium tubes represents a suitable model to imitate a one-wall defect regeneration situation. The established model represents a promising method to evaluate graft consolidation in one-wall defect configuration.

Comparison between two bone substitutes for alveolar ridge preservation after tooth extraction: Cone-beam computed tomography results of a non-inferiority randomized controlled trial.

To test the non-inferiority of demineralized bovine bone mineral (DBBM) compared to DBBM with 10% collagen (DBBM-C) for maintenance of bone volume after tooth extraction in the anterior maxilla. Sixty-six patients were randomly treated with DBBM or DBBM-C, both of which were covered with a collagen matrix for ridge preservation in the anterior maxilla. Cone-beam computed tomographic analysis was performed immediately and 4months after treatment. The primary outcome, for which non-inferiority of DBBM was tested, was change in the horizontal ridge width 1mm below the buccal alveolar crest (HW-1) 4months after extraction. Four months after extraction, HW-1 measured -1.60mm±0.82mm for DBBM-C, while the DBBM group showed a mean loss of -1.37mm±0.84mm (p=0.28, 0.23 [95% CI: -0.19; 0.64]). The horizontal ridge width at 3mm (HW-3) showed -0.98mm (±0.67mm) for DBBM-C and -0.84mm (±0.62mm) for DBBM (p=0.40, 0.12 [95% CI: -0.19; 0.45]), and the horizontal ridge width at 5mm (HW-5) showed -0.67mm (±0.47mm) for DBBM-C and -0.56mm (±0.48mm) for DBBM (p=0.36, 0.11 [95% CI: -0.13; 0.34]). The present clinical trial demonstrated non-inferiority of DBBM compared to DBBM-C for maintenance of alveolar bone volume 4months after tooth extraction in the anterior maxilla.

A randomized clinical trial evaluating maxillary sinus augmentation with different particle sizes of demineralized bovine bone mineral: histological and immunohistochemical analysis

This study was performed to investigate sinus floor augmentation with two different particle sizes of demineralized bovine bone mineral (DBBM) by means of histological and immunohistochemical (IHC) analysis. A randomized clinical trial was conducted involving 10 individuals requiring two-stage bilateral maxillary sinus augmentation for implant installation. The patients were randomly divided into two groups following a split-mouth design: the maxillary sinus on one side was filled with small-sized particles (0.25–1mm) and on the contralateral side with large-sized particles (1–2mm). After a healing period of 8 months, 25 implants were placed. During implant site preparation, bone biopsies were obtained from each sinus, perpendicular to the long axis of the implant (buccal–palatal direction), for descriptive and histomorphometric analyses. IHC staining for protein expression of osteocalcin (OCN), vascular endothelial growth factor (VEGF), and tartrate-resistant acid phosphatase (TRAP) was also performed. Histomorphometric analysis revealed no statistically significant difference in the percentage of biomaterial (32.4±8.56% and 38.0±6.92%), newly formed bone (36.1±9.60% and 36.7±5.79%), or connective tissue (30.4±8.63% and 23.8±6.16%) between the small- and large-sized particle groups, respectively. IHC analysis did not reveal differences in the expression of OCN, VEGF, or TRAP. These findings suggest that both particle sizes of DBBM are effective for bone augmentation in the maxillary sinus.

Impact of particulate deproteinized bovine bone mineral and porous titanium granules on early stability and osseointegration of dental implants in narrow marginal circumferential bone defects

The use of two particulate bone graft substitute materials in experimental narrow marginal peri-implant bone defects was investigated with respect to early bone healing and implant stability. Porous titanium granules, oxidized white porous titanium granules (WPTG), and demineralized bovine bone mineral (DBBM) were characterized in vitro, after which the two latter materials were tested in experimental peri-implant bone defects in six minipigs, with empty defects as control. After mandibular premolar extraction, the top 5mm of the alveoli were widened to 6mm in diameter, followed by the placement of six implants, three on each side, in each pig. Six weeks of healing was allowed. The WPTG showed better mechanical properties. No significant differences in resonance frequency analysis were found directly after compacting or healing, and similar quantities of defect bone formation were observed on micro-computed tomography for all groups. Histomorphometric analysis demonstrated a more coronal bone-to-implant contact in the DBBM group, which also displayed more defect bone fill as compared to the WPTG group. The better mechanical properties observed for WPTG appear of negligible relevance for the early stability and osseointegration of implants.

Peri-Implant Mucositis and Peri-Implantitis: A Current Understanding of Their Diagnosis, Clinical Implications, and a Report of Treatment Using a Combined Therapy Approach.

Abstract The clinical condition involving dental implants, characterized by soft tissue inflammation, bleeding, suppuration and rapid bone loss is widely known as peri implantitis. The main objective in the treatment of peri-implantis is to arrest the progression of the disease and at the same time to keep the dental implant in the mouth solving the inflammations signs of bleeding and pain. The aim of this paper is to highlight the effectiveness of the use of titanium brush and antimicrobial photodynamic therapy (aPDT) to decontaminate the implant surface, in association with regenerative procedures by means of autologous bone and demineralized bovine bone mineral (DBBM) in the treatment of peri-implantitis defects.

Effect of recombinant PDGF-BB on bone formation in the presence of β-tricalcium phosphate and bovine bone mineral matrix: a pilot study in rat calvarial defects.

BackgroundSupplementation of bone substitutes with recombinant platelet-derived growth factor-BB (PDGF-BB) can enhance bone regeneration. The aim of the study was to evaluate the effect of PDGF-BB on bone formation in the presence of β-tricalcium phosphate and bovine bone mineral matrix in a rat calvaria defect model.MethodsThe authors examined 5 mm rat calvarial defects treated with β-tricalcium phosphate (TCP) or demineralized bovine bone mineral (DBBM) with and without 0.3 mg/ml recombinant PDGF-BB. Calvaria defects were randomly divided into the following treatment groups (n = 5); TCP; TCP plus PDGF-BB; DBBM; DBBM plus PDGF-BB; and untreated empty control. After 45 days, bone formation was evaluated by histomorphometry and fluorescence microscopy.ResultsThe authors report that the area of newly formed bone was similar between the empty controls and the two bone substitutes, TCP and DBBM. Supplementation of TCP and DBBM with PDGF-BB had no significant impact on bone formation. Fluorochrome staining revealed no visible changes in the pattern of bone formation in defects filled with TCP and DBBM, irrespective of PDGF-BB. Furthermore, supplementation with PDGF-BB did not influence biomaterial degradation.ConclusionsThe authors concluded that PDGF-BB had no impact on bone formation and degradation of bone substitutes in the respective rodent models. Thus, possible beneficial effects of PDGF-BB may require other model situations.

Different bone regeneration patterns in periimplant circumferential gap defects grafted with two types of osteoconductive biomaterial.

This study aimed to determine healing patterns in periimplant gap defect grafted with demineralized bovine bone mineral (DBBM) and porous titanium granules (PTG), which are known to induce a minimal tissue reaction and to undergo minimal biodegradation in healing process. Experiments were performed using a standardized periimplant gap-defect model in dogs with two observational periods: 4 and 8 weeks. Circumferential defects were surgically induced around dental implants on unilateral mandibles in five dogs, and collagen barrier membranes were placed over the DBBM and PTG grafts at two experimental sites and over a nongrafted site. Four weeks later, the same procedures were performed on the contralateral mandible, and the animals allowed to heal for a further 4 weeks, after which they were sacrificed and their mandibles with graft/control sites harvested for histologic evaluation. Both types of grafted biomaterials significantly enhanced the defect fill with newly formed bone, but the bone-to-implant contact (BIC) was significantly increased only at sites that had been grafted with DBBM. The two experimental sites exhibited different healing patterns, with new bone formation being observed on the surface of the DBBM particles throughout the defect, while there was no de novo bone formation on the PTG surface, but rather appositional bone growth from the base and lateral walls of the defect. It has been suggested that gap-defect filling with DBBM around dental implants may enhance both BIC and defect fill; however, the present findings show that defect grafting with PTG enhances only defect fill and not BIC. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 1202-1209, 2016.

A Retrospective Evaluation of 192 Implants Placed in Augmented Bone: Long-Term Follow-Up Study.

The purpose of the present study was to assess the cumulative survival rate (CSR) of 192 implants placed in association with guided bone regeneration (GBR) procedures to evaluate the long-term predictability of this technique. Moreover, the Kaplan Meier survival analysis was applied to the data in order to evaluate predictors of implant failures, including the source of the graft, the type of membrane, and the timing of implant placement. The CSR of the sample was 95.6% over a mean follow-up period of 78 months (range, 1-175 months). Considering the source of graft, a 95.0%, 93.3%, and 97.7% CSR was obtained for demineralized bovine bone mineral (DBBM), autologous, and 1:1 ratio mixture of autologous and DBBM grafts,, respectively. The CSR referred to bioabsorbable membranes was 96.5%, whereas 94.6% was the CSR reported for nonresorbable membranes. The CSR of simultaneous surgeries was 96.8%, whereas staged surgeries showed a CSR of 94.5%. According to the data, implants placed in conjunction with GBR procedures presented a satisfying survival rate even in the long term. All the procedures performed with different bone grafts and type of membranes guaranteed optimal results both in one- and two-stage approaches. No statistically significant differences could be detected among the groups; indeed, the use of DBBM associated with resorbable membranes may be suggested to reduce patients' morbidity and treatment time. Therefore, the dental implants placed in association with bone regenerative procedures presented safe and predictable long-term clinical results.

Long‐term outcome of implants placed with guided bone regeneration (GBR) using resorbable and non‐resorbable membranes after 12–14 years

The aim of the present prospective study was to evaluate the long-term outcome of implants placed simultaneously with guided bone regeneration (GBR) using resorbable and non-resorbable membranes. The original study population consisted of 72 patients receiving a total of 265 implants. In all GBR-treated sites, demineralized bovine bone mineral (DBBM) was used in combination either with a collagen (CM) or an Expanded polytetrafluoroethylene (e-PTFE) membrane. A total of 112 implants was treated with CM, 41 implants were treated with e-PTFE membranes, and 112 served as a control group because implants were entirely surrounded by bone and did not need any GBR procedures. Clinical and radiographic analyses were performed after a period of 12-14 years. The median follow-up time was 12.5 years (range 12-14 years). A total of 58 patients participated in the present investigation, corresponding to 80.5% of the original study population. The cumulative implant survival rate at the follow-up examination was 93.2%. For the control group the cumulative survival rate was 94.6%, for the CM 91.9%, and for the e-PTFE 92.6%. Differences among the groups were not statistically significant. The radiographically determined marginal bone level (MBL) amounted to: control 2.36 mm (SD), CM 2.4 mm (SD), e-PTFE 2.53 mm (SD). There is no evidence (P < 0.2) that the slope of bone level over time is different for the three treatment groups. It is concluded that implants placed simultaneously with GBR procedures using resorbable or non-resorbable membranes reveal a high survival rate ranging from 91.9% to 92.6%, therefore it is considered to be a safe and predictable therapy. [Correction added after online publication 30 November 2012: the marginal bone level of CM, e-PTFE, and control was corrected to 'control 2.36 mm (SD), CM 2.4 mm (SD), e-PTFE 2.53 mm (SD)' in the Results section].