Oral Gel Research Articles

A pH/Time/Pectinase-Dependent Oral Colon-Targeted System Containing Isoliquiritigenin: Pharmacokinetics and Colon Targeting Evaluation in Mice.

Oral colon-targeted gel beads containing isoliquiritigenin (ISL) were successfully designed in our study. In order to further explore the targeting of the colon by the gel beads, a systematic study of their in vivo pharmacokinetics and colon targeting was performed in mice. Eighteen male mice were included in this study. The mice were separated into six groups at random. We collected blood, stomach, duodenum, jejunum, ileum, and colon tissues at 2, 4, 6, 8, 12, and 24h after oral administration of gel beads containing isoliquiritigenin at a dose of 20mg/kg. Gel beads in tissues were recorded and taken out to observe their swelling and erosion. The total ISL concentrations in different tissues and gel beads were analyzed by high-performance liquid chromatography. All gel beads reached the upper part of the stomach at 2h with no obvious swelling. Most of the gel beads were still in the lower part of stomach, while a small amount had reached the small intestine at 4h. A few gel beads reached the colon and swelled at 6h. Furthermore, the gel beads in the colon were swollen and erosive at 8h. Meanwhile, the plasma ISL concentration could be detected, which indicated that the ISL in the gel beads was absorbed. At 12h, the gel beads were almost dissolved and the plasma concentration was 8.33 times that at 8 h. At 24h, the gel beads had completely disappeared, and the plasma concentration was 2.55 times that at 12h. The gel beads containing ISL are a sustained, controlled, and colon-targeting delivery system that can alter the ISL distribution in the gastrointestinal tract.

Effects of Dextrose Gel in Preventing and Treating Neonatal Hypoglycemia: A Systematic Review and Meta-analysis

Neonatal hypoglycemia is one of the major complications in neonatal wards, requiring rapid diagnosis and treatment to prevent its complications. Dextrose gel is used as a cheap and safe choice. Thus, the present systematic review and meta-analysis study aimed to investigate the effects of oral dextrose gel in preventing and treating neonatal hypoglycemia. To find the relevant articles, the national databases, including Barekat Gostar, SID, Magiran, IranDoc, and international databases, including PubMed, Scopus, Web of Science, Cochrane, and Google Scholar were consulted with standard keywords. The data were analyzed using the STATA 14 software, while the P value < 0.05 was considered significant. In 9 articles with a sample size of 8755 neonates, the mean neonatal weight ranged from 2890 to 3669 g. The share of neonates born through normal vaginal delivery equaled 61%, while 16% had low birth weight (below 2500 g), 16% had high birth weight (above 4500 g), 51% had diabetic mothers, 20% were premature, and 88% were singleton. Oral dextrose gel reduced the risk of neonatal hypoglycemia by OR=0.83 (95% CI: 0.75-0.93). However, neonatal hypoglycemia treatment with oral dextrose gel had an OR=0.78 (95% CI: 0.57-1.07), which was not statistically significant. Oral dextrose gel was effective in preventing neonatal hypoglycemia.

Clinical evaluation of coffee based gel on gingivitis: A randomised controlled clinical trial

Introduction: Gingivitis is a non -destructive, plaque induced infection that causes inflammation of the gingiva. Coffee is considered to be the biggest source of dietary cancer prevention agents in industrialized countries. Caffeine, caffeic corrosive and chlorogenic corrosive are the dynamic components of coffee that have found to have anti-inflammatory and anti-oxidative impacts.Objective: To evaluate the effectiveness of Coffee as an oral gel in the reduction of plaque and gingivitis.Materials and Method: This single center, randomized controlled clinical trial was carried out among 30 participants with mild to moderate gingivitis. Group I, Scaling with application of coffee gel (Test) and Group II, Scaling only (Control) [n=15]. Group I subjects were instructed to use coffee gel twice daily following scaling. Clinical parameters (Turesky Gilmore Glickman Modification of Quigley Hein Plaque Index and Loe and Silness Gingival Index) were recorded at baseline,15 day and 1month post-operatively. Student’s paired t test and Independent t-test were used for intra and inter group comparison of clinical parameters.Result: On intragroup comparison, both the groups showed a statistically significant difference at 1 month. But on intergroup comparison, there was no statistically significant difference between the test group and control group.

Implementing Oral Glucose Gel in the Treatment of Newborn Hypoglycemia

A gap in practice existed for newborns exhibiting hypoglycemia shortly after birth, especially for exclusively breastfed newborns. If the newborn remained hypoglycemic after breastfeeding, the options were to provide formula or transfer to a higher level of care for intravenous dextrose. Additionally, if a formula-fed newborn remained hypoglycemic with additional feedings, the only other option was to transfer the newborn to the NICU for intravenous dextrose. The average daily cost of care in the NICU is approximately $3,000 (U.S.).

Use of Oral Glucose Gel for Newborn Hypoglycemia to Reduce Intravenous Treatment

Traditionally, treatment for newborn hypoglycemia has been focused around feeding and then intravenous fluid (dextrose 10%) treatment. This results in the newborn being separated from the parents for invasive procedures and causes delays in skin-to-skin contact and breastfeeding. Evidence shows that initial sustained skin-to-skin contact is key to breastfeeding success and stable neonate cortisol levels. The use of oral 40% glucose gel as an alternative to intravenous fluid can be provided easily while the neonate is skin-to-skin, is noninvasive, and does not require advanced skill of the nursing staff, therefore using fewer resources.

Stable Solid Dispersion Incorporated Sustained Release Oral Gel of 23 mg Donepezil Hcl

The objective of the present study is to formulate and evaluate stable solid dispersion incorporated sustained release oral gel of donepezil Hcl. Solid dispersions were prepared using HPMC K100M and stearic acid using physical mixture, co-grinding and fusion methods and incorporated into the previously prepared gel bases using sodium CMC and sodium alginate and suitable formulation was optimised. All the formulations were subjected to physicochemical evaluation parameters. Solid dispersions of donepezil were prepared with HPMC K100 and stearic acid by using different methods like physical mixtures, co grinding and fusion method in the ratios of 1:1, 1:2 and 1:3. From the invitro dissolution studies, it was found that SD made by co grinding and fusion method showed sustained release and were selected and incorporated into the gel formulations made of SCMC 4% and sodium alginate 4%. The release studies of solid dispersion incorporated gel SD-HPMC K100M showed (SDG1) 87.55% and (SDG2) 88.9% at 8th hour and SD-stearic acid showed (SDG3) 83.26% and (SDG4) 82.57% at 8th hour. It was concluded that stearic acid solid dispersions incorporated in sodium CMC gels (SDG3) were optimised using short term stability studies with no leakage of drug in comparison to solid dispersions of HPMC K100M in sodium CMC gel l. Physico-chemical evaluation parameters were carried out for optimised formulations and found to be within limits. The optimized SD incorporated gel formulation of donepezil can be an alternative to SR tablet in improving the compliance of the geriatric patients.

The challenges of keeping clinicians unaware of their participation in a national, cluster-randomised, implementation trial

BackgroundImplementation of recommendations from clinical practice guidelines is essential for evidence based clinical practice. However, the most effective methods of implementation are unclear. We conducted a national, cluster-randomised, blinded implementation trial to determine if midwife or doctor local implementation leaders are more effective in implementing a guideline for use of oral dextrose gel to treat hypoglycaemic babies on postnatal wards. To prevent any conscious or unconscious performance bias both the doctor and midwife local implementation leaders were kept unaware of the trial. This paper reports the ethical dilemmas and practical challenges of ensuring clinicians remained unaware of their involvement in an implementation trial.MethodsWe sought approval from the National Health and Disability Ethics committee to keep clinicians unaware of the trial by waiving the standard requirement for locality approval usually required for each district health board. The ethics committee did not approve a waiver of consent but advised that we approach the chief executive of each district health board to ask for provisional locality approval. Ultimately it was necessary to seek ethics approval for three separate study designs to keep clinicians unaware of the trial.ResultsThe median (IQR) time for chief executive approval was 16 (6–40) days and for locality approval was 57 (39–84) days. We completed 21 different locality approval forms for 27 hospitals.ConclusionsKeeping clinicians unaware of their involvement in a national implementation cluster-randomised trial is feasible. However, despite a national ethics committee, significant logistical challenges were time consuming and delayed trial completion. Co-ordination of the locality approval process would help facilitate multi-centre trials.

How effective and safe is oral dextrose gel in correcting hypoglycemia in newborn infants?

How effective and safe is oral dextrose gel in correcting hypoglycemia in newborn infants?

Evaluation of clinical, histology, TNF-α, and collagen expressions on oral ulcer in rats after treatment with areca nut and chrysanthemum oral gel

Background: Areca nut (Areca catechu Linn.) is the seed of the fruit of the oriental palm that is commonly used among Southeast Asian communities. Chrysanthemum (Dendrathema grandiflora) is a flowering plant originating from East Asia and dominantly grows in China. Both of these plants have strong antioxidant activities. To investigate the mechanism of their wound healing activities, we prepared areca nut and chrysanthemum polyethylene oral gel and performed several in vivo assays using Sprague–Dawley rats. Methods: Sprague–Dawley rats were divided into five groups: Negative control group (rats with base gel treatment), positive control group (rats treated with triamcinolone acetonide), F1 (treatment with 20% areca nut:80% chrysanthemum), F2 (treatment with 50% areca nut:50% chrysanthemum), and F3 (treatment with 80% areca nut:20% chrysanthemum). Traumatic ulcers were performed on the buccal mucosa of all experimental animals that received topical oral gel and triamcinolone acetonide twice a day for seven days. The clinical and histological characteristics were analyzed and scored. Results: During the six days, the ulcerated area receded linearly over time and was completely cicatrized in F2, F3, and positive control group (Dependent t-test, p<0.05). There were significant increases in body weight in F2 and positive control groups. There were no significant differences between groups in histology examination (Kruskal Wallis test, p<0.05). The moderate score of TNF-α levels was seen in F2 and positive control groups (ANOVA/Tukey test, p<0.05). In the collagenases assay, a high concentration of areca nut (F3) induced the abundance of collagen during the ulcer healing process. Conclusions: The combination of areca nut and chrysanthemum extract in the oral gel can optimize the healing of traumatic oral ulcers in Sprague-Dawley rats through the increase of TNF-α and collagen deposition.

The Pre-Testosterone Therapy Checklist

In contemporary practice, there are a myriad of testosterone therapy (TTH) modalities of exogenous TTH in the form of oral agents, gels, patches, transnasal agents, subcutaneous and intramuscular injections. A number of so-called alternative agents are available to patients, especially those for whom fertility is a major concern, in the form of clomiphene citrate, aromatase inhibitors, and human chorionic gonadotropin.

Standard-Dose Oral Dextrose Gel for Neonatal Hypoglycemia

Standard-Dose Oral Dextrose Gel for Neonatal Hypoglycemia

Oral hairy leukoplakia in an immunocompetent patient treated with topical steroids for oral lichen planus

<h3>Objectives</h3> Oral Hairy Leukoplakia (OHL) is an Epstein-Barr Virus (EBV)-related lesion of the oral mucosa, most commonly affecting immunocompromised patients. Although HIV-infection appears to be the most frequent pre- disposing factor, OHL cases have been reported in patients with other causes of systemic or even local immuno- suppression. Herein, we present a case of OHL arising in an HIV-negative immunocompetent patient treated with topical steroids for Oral Lichen Planus (OLP). <h3>Findings</h3> A 62 years old male patient with biopsy-proven OLP presented for his regular follow-up. He was un- der treatment with topical steroids: fluocinonide (oral gel) and dexamethazone (oral solution). Clinical examina- tion revealed a white plaque of irregular surface involving the right lateral border of the tongue, which had not been noticed in the previous follow up appointment, 2 months ago. With a differential diagnosis of morsicatio linguarum, hypertrophic OLP and leukoplakia, an incisional biopsy was performed. Histopathologic examination revealed hyperkeratotic squamous epithelium with surface corrugations and the presence of "balloon cells" in the upper spinous layer, some of which exhibited nuclear beading in high power magnification. Immunohistochem- ical examination for EBV-LMP1 and in-situ hybridization for EBV were positive, establishing a diagnosis of OHL. Although no symptoms or signs of immunosuppression/HIV infection were present, the patient underwent blood examinations, including an HIV ELISA antibody test, which were within normal limits. In the absence of any in- dications of systemic causes, a diagnosis of OHL associated with local immunosuppression due to long-term use of topical corticosteroids was rendered. <h3>Conclusions</h3> OHL may be associated with different types of immunosuppression. In recent years, few cases of OHL developing in patients treated with topical steroids have been reported, the majority of which were linked to inhalers for pulmonary diseases. Topical steroid-induced immunosuppression in patients with oral mucocutaneous diseases should be considered as a possible, albeit unusual, cause of OHL.

Topical Herbal Therapeutic Formulation used in the Management of Oral Potentially Malignant Disorders – A Systematic Review

Background: Oral potentially malignant disorders (OPMDs) are divided into two groups precancerous lesions, a benign lesion with morphologically altered tissue, which has a greater than normal risk of transforming into malignancy, and precancerous conditions, a disease or patient's habit that does not necessarily alter the appearance of local tissues but is associated with a greater or normal risk of precancerous lesion or cancer development in that tissue. Aim: This systematic review aims to evaluate the effectiveness of topical herbal therapeutics in the management of potentially malignant oral disorders. Objective: Primary objective was to evaluate the efficiency of tulsi, aloe vera, and turmeric in the management of OPMDs, and the secondary objective was to determine the herbal therapeutic response in patients with oral leukoplakia oral sub, mucous fibrosis, and lichen planus. Data Sources and Search Methods: The search was done using the MeSH [medical subject headings] terms and keyword search in the electronic databases, namely Pub Med and Google Scholar. The studies included in this systematic review were identified by a comprehensive search from the electronic search engines like Pub Med Advanced search (from April up to January 2021) and Google scholar. The search yielded 39 articles out of which 11 articles were only included based on the inclusion criteria. Data Collection and Analysis: All the studies included were based on the data extraction and analysis of the studies for quality. The outcome measure evaluated the reduction in burning sensation, mouth opening, and clinical resolution of the lesion. Results: A total of 39 articles were included in this systematic review from electronic searches using Pub Med advanced search and Google scholar. Conclusion: For management of oral submucous fibrosis topical aloe vera gel showed 90% of complete clinical response, oral lichen planus topical tulsi and turmeric gel showed 90% complete clinical response, and only two studies were conducted on oral leukoplakia which had a high risk of bias; hence, this systematic review does not yield to a piece of conclusive evidence for the management of oral leukoplakia using topical herbal therapeutics.

Prophylactic Oral Dextrose Gel and Neurosensory Impairment at 2-Year Follow-up of Participants in the hPOD Randomized Trial

Prophylactic oral dextrose gel reduces neonatal hypoglycemia, but later benefits or harms remain unclear. To assess the effects on later development of prophylactic dextrose gel for infants born at risk of neonatal hypoglycemia. Prospective follow-up of a multicenter randomized clinical trial conducted in 18 Australian and New Zealand hospitals from January 2015 to May 2019. Participants were late preterm or term at-risk infants; those randomized in 9 New Zealand centers (n = 1359) were included and followed up between January 2017 and July 2021. Infants were randomized to prophylactic 40% dextrose (n = 681) or placebo (n = 678) gel, 0.5 mL/kg, massaged into the buccal mucosa 1 hour after birth. The primary outcome of this follow-up study was neurosensory impairment at 2 years' corrected age. There were 44 secondary outcomes, including cognitive, language, and motor composite Bayley-III scores (mean [SD], 100 [15]; higher scores indicate better performance). Of eligible infants, 1197 (91%) were assessed (581 females [49%]). Neurosensory impairment was not significantly different between the dextrose and placebo gel groups (20.8% vs 18.7%; unadjusted risk difference [RD], 2.09% [95% CI, -2.43% to 6.60%]; adjusted risk ratio [aRR], 1.13 [95% CI, 0.90 to 1.41]). The risk of cognitive and language delay was not significantly different between the dextrose and placebo groups (cognitive: 7.6% vs 5.3%; RD, 2.32% [95% CI, -0.46% to 5.11%]; aRR, 1.40 [95% CI, 0.91 to 2.17]; language: 17.0% vs 14.7%; RD, 2.35% [95% CI, -1.80% to 6.50%]; aRR, 1.19 [95% CI, 0.92 to 1.54]). However, the dextrose gel group had a significantly higher risk of motor delay (2.5% vs 0.7%; RD, 1.81% [95% CI, 0.40% to 3.23%]; aRR, 3.79 [95% CI, 1.27 to 11.32]) and significantly lower composite scores for cognitive (adjusted mean difference [aMD], -1.30 [95% CI, -2.55 to -0.05]), language (aMD, -2.16 [95% CI, -3.86 to -0.46]), and motor (aMD, -1.40 [95% CI, -2.60 to -0.20]) performance. There were no significant differences between groups in the other 27 secondary outcomes. Among late preterm and term infants born at risk of neonatal hypoglycemia, prophylactic oral 40% dextrose gel at 1 hour of age, compared with placebo, resulted in no significant difference in the risk of neurosensory impairment at 2 years' corrected age. However, the study may have been underpowered to detect a small but potentially clinically important increase in risk, and further research including longer-term follow-up is required. anzctr.org.au Identifier: ACTRN12614001263684.

Oral dextrose gel for the treatment of hypoglycaemia in newborn infants.

Neonatal hypoglycaemia, a common condition, can be associated with brain injury. It is frequently managed by providing infants with an alternative source of glucose, often given enterally with milk-feeding or intravenously with dextrose solution, which may decrease breastfeeding success. Intravenous dextrose also often requires that mother and baby are cared for in separate environments. Oral dextrose gel is simple and inexpensive, and can be administered directly to the buccal mucosa for rapid correction of hypoglycaemia, in association with continued breastfeeding and maternal care. This is an update of a previous review published in 2016. To assess the effectiveness of oral dextrose gel in correcting hypoglycaemia in newborn infants from birth to discharge home and reducing long-term neurodevelopmental impairment. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase from database inception to October 2021. We also searched international clinical trials networks, the reference lists of included trials, and relevant systematic reviews identified in the search. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing oral dextrose gel versus placebo, no treatment, or other therapies for the treatment of neonatal hypoglycaemia in newborn infants from birth to discharge home. Two review authors independently assessed study quality and extracted data; they did not assess publications for which they were study authors. We contacted investigators to obtain additional information. We used fixed-effect models and the GRADE approach to assess the certainty of evidence. We included two studies conducted in high-income countries, involving 312 late preterm and at-risk term infants and comparing oral dextrose gel (40% concentration) to placebo gel. One study was at low risk of bias, and the other (an abstract) was at unclear to high risk of bias. Oral dextrose gel compared with placebo gel probably increases correction of hypoglycaemic events (rate ratio 1.08, 95% confidence interval (CI) 0.98 to 1.20; rate difference 66 more per 1000, 95% CI 17 fewer to 166 more; 1 study; 237 infants; moderate-certainty evidence), and may result in a slight reduction in the risk of major neurological disability at age two years or older, but the evidence is uncertain (risk ratio (RR) 0.46, 95% CI 0.09 to 2.47; risk difference (RD) 24 fewer per 1000, 95% CI 41 fewer to 66 more; 1 study, 185 children; low-certainty evidence). The evidence is very uncertain about the effect of oral dextrose gel compared with placebo gel or no gel on the need for intravenous treatment for hypoglycaemia (RR 0.78, 95% CI 0.46 to 1.32; RD 37 fewer per 1000, 95% CI 91 fewer to 54 more; 2 studies, 312 infants; very low-certainty evidence). Investigators in one study of 237 infants reported no adverse events (e.g. choking or vomiting at the time of administration) in the oral dextrose gel or placebo gel group (low-certainty evidence). Oral dextrose gel compared with placebo gel probably reduces the incidence of separation from the mother for treatment of hypoglycaemia (RR 0.54, 95% CI 0.31 to 0.93; RD 116 fewer per 1000, 95% CI 174 fewer to 18 fewer; 1 study, 237 infants; moderate-certainty evidence), and increases the likelihood of exclusive breastfeeding after discharge (RR 1.10, 95% CI 1.01 to 1.18; RD 87 more per 1000, 95% CI 9 more to 157 more;1 study, 237 infants; moderate-certainty evidence). AUTHORS' CONCLUSIONS: Oral dextrose gel (specifically 40% dextrose concentration) used to treat hypoglycaemia in newborn infants (specifically at-risk late preterm and term infants) probably increases correction of hypoglycaemic events, and may result in a slight reduction in the risk of major neurological disability at age two years or older. Oral dextrose gel treatment probably reduces the incidence of separation from the mother for treatment and increases the likelihood of exclusive breastfeeding after discharge. No adverse events have been reported. Oral dextrose gel is probably an effective and safe first-line treatment for infants with neonatal hypoglycaemia in high-income settings. More evidence is needed about the effects of oral dextrose gel treatment on later neurological disability and the need for other treatments for hypoglycaemia. Future studies should be conducted in low-and middle-income settings, in extremely and moderately preterm infants, and compare oral dextrose gel with other therapies such as intravenous dextrose. There are two ongoing studies that may alter the conclusions of this review when published.

Domiciliary Use of Chlorhexidine vs. Postbiotic Gels in Patients with Peri-Implant Mucositis: A Split-Mouth Randomized Clinical Trial

Peri-implant mucositis is a pathological condition characterized by an inflammatory process in the peri-implant soft tissues. Progression to peri-implantitis takes place in case of peri-implant bone resorption. Recently, an aid for non-surgical treatment by mechanical debridement (SRP) has been identified in probiotics. As there are no recent studies regarding their use for peri-implant mucositis, the aim of this study was to test a new postbiotic gel for this clinical condition. A split-mouth randomized clinical trial was performed. Twenty patients undergoing SRP were randomly assigned to two treatments based on the following oral gels: chlorhexidine-based Curasept Periodontal Gel (Group 1) and postbiotic-based Biorepair Parodontgel Intensive (Group 2). At baseline (T0) and after three (T1) and six (T2) months, the following peri-implant mucositis indexes were recorded: Probing Pocket Depth (PPD), Plaque Index (PI), Gingival Bleeding Index (GBI), Bleeding Score (BS), Marginal Mucosal Condition (MMC). A significant decrease is reported for both postbiotic and chlorhexidine for all peri-implant mucositis indices studied. Quite the opposite, no significant variation was present in intergroup comparisons. Greater improvements for BS, GBI and MMC inflammatory indices of the postbiotic gel compared to chlorhexidine suggest the importance of further studies to investigate the relevance of the product alone.

Topical Medicine Potency of Musa paradisiaca var. sapientum (L.) kuntze as Oral Gel for Wound Healing: An In Vitro, In Vivo Study.

Topical application of ambonese banana (Musa paradisiaca var. sapientum (L.) kuntze) stem sap gel (GEGPA) on the socket wound area showed an increase in the expression of platelet-derived growth factor-BB, while decrease in the expression of matrix metalloproteinase-2 and 9. The aim of this study is to achieve standard formulation of GEGPA through stability, viscosity, distribution area, and drugs release for oral gel wound healing. This is an in vitro and in vivo study with the randomized posttest only control group design. The gel was formulated according to the composition of each group by adding hydroxypropyl methylcellulose (HPMC), Lexgard, propylene glycol, and cold water to obtain 100 g of gel. Observations were made through the following tests: stability, viscosity, distribution area, drug release, and histopathological analysis of tooth extraction wound healing. Data were analyzed using a one-way analysis of variance (α = 0.05) with GraphPad Prism-8 statistical software. The study showed that the GEGPA formulation was stable against changes in consistency, color, smell, homogeneity, and pH value. There is a significant difference between groups with respect to viscosity (p = 0.0001), adhesion (p = 0.004), dispersion (p = 0.000), and fibroblast cell numbers on days 3 and 5 (p = 0.007 and p = 0.001). There is no interaction between the active ingredients and the gel base of all formulations. Formulation 3 had better properties in terms of viscosity, broad distribution, and drug release compared with other groups. Application of GEGPA to tooth extraction wounds showed a significant proliferation of fibroblast cells on days 3 and 5. The formulation of M. paradisiaca var. sapientum (L.) kuntze extract with HPMC and propylene glycol obtained a gel preparation, GEGPA, that was organoleptically stable and met the topical gel standard for wounds in the oral cavity.

Evaluating the Preemptive Analgesic Effect of Photo-biomodulation Therapy on Pain Perception During Local Anesthesia Injection in Children: A Split-mouth Triple-blind Randomized Controlled Clinical Trial.

To evaluate the impact of photobiomodulation therapy (PBMT) on injection pain perception and compare it with a topical oral anesthetic gel. A total of 30 patients of 6 to 9years-old seeking pulpotomy treatment of maxillary secondary primary molars of both sides were considered for this split-mouth triple-blind randomized clinical trial. On one side of the maxilla, the low-level laser (diode laser, 808 nm, 250 mW; 16.25 J; 32.5 J cm-2 ) was irradiated upon the buccal gingiva of the tooth, while a Benzocaine 20% topical anesthetic gel was applied on the other side. A gel with the same taste (strawberry) was applied for the placebo. The Wong-Baker Faces Pain Rating Scale was used to evaluate the injection pain and postoperation pain at two timestamps, 1 h and 24 h after treatment. Patients' heart rate was also evaluated. Paired t, Wilcoxon signed-rank test, McNemar and Friedman tests were used for statistical analyses. Results demonstrated that PBMT could significantly decrease the injection pain perception and heart rate alternations compared to the topical anesthetic gels (P = 0.000). However, no significant differences were documented between the two methods concerning the 1-h (P = 0.26) and 24-h (P = 1.00) postoperation pain. PBMT can be an effective nonpharmacological technique for controlling injection pain.

Home Oral Care of Periodontal Patients Using Antimicrobial Gel with Postbiotics, Lactoferrin, and Aloe Barbadensis Leaf Juice Powder vs. Conventional Chlorhexidine Gel: A Split-Mouth Randomized Clinical Trial.

Periodontitis is a progressive destruction of both soft and hard tooth-supporting tissues. In the last years, probiotics have been proposed as a support to the gold standard treatment scaling and root planing (SRP), but no extensive literature is present as regards the effect of the more recent postbiotics. Thirty patients subjected to SRP were randomly assigned to two domiciliary hygiene treatments based on the following oral gels: the postbiotics-based Biorepair Parodontgel Intensive (Group 1) and the chlorhexidine-based Curasept Periodontal Gel (Group 2). At baseline (T0) and after 3 and 6 months (T1–T2), the following periodontal clinical parameters were recorded: Probing Pocket Depth (PPD), recession, dental mobility, Bleeding on Probing (BoP), and Plaque Control Record (PCR). A significant intragroup reduction was assessed in both groups for PPD, BoP, and PCR; conversely, recession significantly increased in both groups, whereas dental mobility did not vary. As regards intergroup comparisons, no statistically significant differences were assessed. Both gels, respectively, containing antioxidant natural ingredients and chlorhexidine, are effective for the domiciliary treatment of periodontitis. Further studies are required to evaluate the singular chemical compounds of the gels expected to exert the beneficial action assessed in this preliminary study.

The D-Health Trial: a randomised controlled trial of the effect of vitamin D on mortality

The effect of supplementing unscreened adults with vitamin D3 on mortality is unclear. We aimed to determine whether monthly doses of vitamin D3 influenced mortality in older Australians. We did a randomised, double-blind, placebo-controlled trial of oral vitamin D3 supplementation (60 000 IU per month) in Australians 60 years or older who were recruited across the country via the Commonwealth electoral roll. Participants were randomly assigned (1:1), using automated computer-generated permuted block randomisation, to receive one oral gel capsule of either 60 000 IU vitamin D3 or placebo once a month for 5 years. Participants, staff, and investigators were blinded to study group allocation. The primary endpoint was all-cause mortality assessed in all participants who were randomly assigned. We also analysed mortality from cancer, cardiovascular disease, and other causes. Hazard ratios (HRs) and 95% CIs were generated using flexible parametric survival models. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000743763. Between Feb 14, 2014, and June 17, 2015, we randomly assigned 21 315 participants, including 10 662 to the vitamin D group and 10 653 to the placebo group. In 4441 blood samples collected from randomly sampled participants (N=3943) during follow-up, mean serum 25-hydroxy-vitamin D concentrations were 77 (SD 25) in the placebo group and 115 (SD 30) nmol/L in the vitamin D group. Following 5 years of intervention (median follow-up 5·7 years [IQR 5·4-6·7]), 1100 deaths were recorded (placebo 538 [5·1%]; vitamin D 562 [5·3%]). 10 661 participants in the vitamin D group and 10 649 participants in the placebo group were included in the primary analysis. Five participants (one in the vitamin D group and four in the placebo group) were not included as they requested to be withdrawn and their data to be destroyed. The HR of vitamin D3 effect on all-cause mortality was 1.04 [95% CI 0·93 to 1·18]; p=0·47)and the HR of vitamin D3 effect on cardiovascular disease mortality was 0·96 (95% CI 0·72 to 1·28; p=0·77). The HR for cancer mortality was 1·15 (95% CI 0·96 to 1·39; p=0·13) and for mortality from other causes it was 0·83 (95% CI 0·65 to 1·07; p=0·15). The odds ratio for the per-protocol analysis was OR 1·18 (95% CI 1·00 to 1·40; p=0·06). In exploratory analyses excluding the first 2 years of follow-up, those randomly assigned to receive vitamin D had a numerically higher hazard of cancer mortality than those in the placebo group (HR 1·24 [95% CI 1·01-1·54]; p=0·05). Administering vitamin D3 monthly to unscreened older people did not reduce all-cause mortality. Point estimates and exploratory analyses excluding the early follow-up period were consistent with an increased risk of death from cancer. Pending further evidence, the precautionary principle would suggest that this dosing regimen might not be appropriate in people who are vitamin D-replete. The D-Health Trial is funded by National Health and Medical Research Council.