The Oral Health Statistics Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Explanation and Elaboration.

Adequate and transparent reporting is necessary for critically appraising research. Yet, evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the Oral Health Statistics Guidelines. Drafts were circulated to the editors of 85 oral health journals and to task force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The final version was subsequently approved by the task force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in Journal of Dental Research Clinical and Translational Research, the Journal of the American Dental Association, and the Journal of Oral and Maxillofacial Surgery. Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

The Oral Health Statistical Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: Manuscript Checklist.

Adequate and transparent reporting is necessary for critically appraising published research. Yet, ample evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-identified the minimum information needed to report and evaluate observational studies and clinical trials in oral health: the Oral Health Statistical (OHStat) Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The guidelines were subsequently revised by the Task Force's writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials, Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and Consolidated Standards for Reporting Trials harms guidelines and incorporate the SAMPL guidelines for reporting statistics, the CLIP principles for documenting images, and the GRADE indicating the quality of evidence. The guidelines also recommend reporting estimates in clinically meaningful units using confidence intervals, rather than relying on P values. In addition, OHStat introduces 7 new guidelines that concern the text itself, such as checking the congruence between abstract and text, structuring the discussion, and listing conclusions to make them more specific. OHStat does not replace other reporting guidelines; it incorporates those most relevant to dental researches into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: explanation and elaboration.

Adequate and transparent reporting is necessary for critically appraising research. Yet, evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the OHstat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The final version was subsequently approved by the Task Force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in JDR Clinical and Translational Research, the Journal of the American Dental Association, and the Journal of Oral and Maxillofacial Surgery. Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: manuscript checklist.

Adequate and transparent reporting is necessary for critically appraising published research. Yet, ample evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-identified the minimum information needed to report and evaluate observational studies and clinical trials in oral health: the OHStat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The guidelines were subsequently revised by the Task Force's writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and CONSORT harms guidelines and incorporate the SAMPL guidelines for reporting statistics, the CLIP principles for documenting images, and the GRADE indicating the quality of evidence. The guidelines also recommend reporting estimates in clinically meaningful units using confidence intervals, rather than relying on P values. In addition, OHStat introduces 7 new guidelines that concern the text itself, such as checking the congruence between abstract and text, structuring the discussion, and listing conclusions to make them more specific. OHStat does not replace other reporting guidelines; it incorporates those most relevant to dental research into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.

Evidence that periodontal treatment improves biomarkers and CVD outcomes.

AIM: The aim of this review was to critically appraise the evidence on the impact of periodontal treatment of cardiovascular diseases (CVDs) biomarkers and outcomes. METHODS: A systematic search was performed in Cinhal, Cochrane, Embase and Medline for relevant articles up to July 2012. Duplicate screening and reference hand searching were performed. Data were then summarized and evidence graded in tables. RESULTS: The search resulted in: (a) no evidence on the effects of periodontal therapy on subclinical atherosclerosis, serum levels of CD40 ligand, serum amyloid A and monocyte chemoattractant protein-1, (b) limited evidence on the effects of periodontal therapy on arterial blood pressure, leucocyte counts, fibrinogen, tissue necrosis factor-α, sE-selectin, von Willebrand factors, d-dimers, matrix metalloproteinases, oxidative stress and CVD events, and (c) moderate evidence suggesting a negligible effect of periodontal therapy in reducing interleukin-6 and lipids levels, whilst a positive effect in reducing serum C-reactive protein levels and improving endothelial function. CONCLUSIONS: Periodontal therapy triggers a short-term inflammatory response followed by (a) a progressive and consistent reduction of systemic inflammation and (b) an improvement in endothelial function. There is however limited evidence that these acute and chronic changes will either increase or reduce CVD burden of individuals suffering from periodontitis in the long term.

A comparison of Er,Cr:YSGG laser to minimally invasive surgical technique in the treatment of intrabony defects: Twelve-month results of a multicenter, randomized, controlled study.

BACKGROUND: The purpose of this publication is to report on the 12-month clinical and radiographic results comparing the surgical use of the Er,Cr:YSGG laser (ERL) and minimally invasive surgical technique (MIST) for the treatment of intrabony defects in subjects with generalized periodontitis stage III, grade B. METHODS: Fifty-three adult subjects (29 females and 24 males; 19-73 years) with 79 intrabony defects were randomized following scaling and root planing (SRP) to receive ERL monotherapy (n = 27) or MIST (n = 26). Fifty subjects completed the study. Recession (REC), probing depth (PD), clinical attachment level (CAL), treatment time, and standardized radiographs were assessed and compared for each treatment group. Clinical measurements were recorded at baseline, 4-6 weeks following SRP, and 6 and 12 months following surgical therapy. Radiographic results were compared to baseline at 6 and 12 months following surgical therapy. RESULTS: The following primary and secondary outcome variables were non-inferior with the following margins: CAL with a non-inferiority margin of 0.7 mm (p = 0.05), PD with a non-inferiority margin of 0.7 mm (p = 0.05), and REC with a non-inferiority margin of 0.4 mm (p = 0.05). Standardized radiographs suggest similar bone fill of 1.14 ± 1.73 mm for MIST and 1.12 ± 1.52 mm for ERL. CONCLUSIONS: This is the first multicenter, randomized, masked, and controlled study demonstrating the ERL is not inferior to MIST at 12 months in terms of clinical outcomes and similar to MIST in terms of radiographic bone fill for the surgical treatment of intrabony defects.

Harvest graft substitute for soft tissue volume augmentation around existing implants: A randomized, controlled and blinded multicenter trial.

BACKGROUND: Using a single-blind, randomized, controlled, multicenter, practice-based clinical trial, a volume-stable collagen matrix (VCMX) was compared with connective tissue graft (CTG) for soft tissue augmentation around existing dental implants. METHODS: Sixty patients (31 VCMX and 31 CTG) were included. The primary outcome was a soft tissue thickness change 3 mm below the gingival margin (GM). Secondary outcomes included clinical measures, such as keratinized tissue widths (KTw), probing pocket depths, and pink esthetic scores, and patient-reported outcomes (PRO). RESULTS: There were no significant differences between test and control patient demographics or clinical measures throughout the 1-year study. VCMX "grafts" were by design larger than CTG, and surgery time was less (27% less, p = 0.0005). Three millimeters below the GM (primary endpoint), tissue thickness increase was noninferior for VCMX compared with CTG (0.93 ± 0.80 mm vs. 1.10 ± 0.51 mm, respectively), inferior (by 0.25 mm) at 1 mm, and noninferior at 5 mm. Postoperative pain was significantly less for VCMX patients (p < 0.0001), but all other PRO measures, including esthetics and satisfaction, improved similarly for both therapies. CONCLUSIONS: Given the inclusion criteria for this study, namely soft tissue augmentation around existing implants with some evidence of KTw and minimal recession, VCMX provided soft tissue thickness and volume increases similar (noninferior) to CTG. Clinical measures and PRO were similar between therapies-site sensitivity and esthetics improved similarly for both therapies-but surgery time and pain following surgery were significantly less for VCMX.

Efficacy of a harvest graft substitute for recession coverage and soft tissue volume augmentation: A randomized controlled trial.

BACKGROUND: The autogenous connective tissue graft (CTG) with coronally advanced flap (CTG+CAF) is the "gold standard" for recession defect coverage; however, researchers continue to pursue lower morbidity, more convenient and unlimited supply harvest graft substitutes, including those that could provide soft tissue volume augmentation. METHODS: A randomized, controlled, double-masked comparison of a volume-stable collagen matrix (VCMX) versus CTG was conducted at four clinical investigation sites. Single, contralateral, within patient matched-pair, RT1 recession defects were treated with VCMX+CAF (test) and CTG+CAF (control). The primary efficacy end point was percent root coverage at 6 months. Secondary efficacy end points included clinical measures such as soft tissue volume, attachment level, and keratinized tissue width. Patient-reported outcomes included measures such as discomfort, esthetics, and overall satisfaction; 6-month end point results were followed for 1 year. RESULTS: Thirty patients received control and test therapies, and all patients were available for follow-up measures. Average percent root coverage for CTG+CAF was 90.5% ± 14.87% versus 70.7% ± 28.26% for VCMX+CAF, P <0.0001. Both therapies produced significant soft tissue volume increases (84.8 ± 47.43 mm3 control versus 48.90 ± 35.58 mm3 test, P = 0.0006). The test, harvest graft substitute produced less postoperative pain and was preferred by patients at the 6-month end point. All other end point measures were not significantly different. CONCLUSIONS: VCMX+CAF root coverage was inferior to CTG+CAF but produced less morbidity and was preferred by patients. Case/patient selection and surgical technique appear key to achieving successful results with the harvest graft alternative.

A Prospective, Randomized, Controlled, Multicenter Evaluation of Extraction Socket Management Comparing a Wound Dressing and a Soft Tissue Substitute.

Postextraction bone grafting and implant placement help preserve alveolar bone volume. Collagen wound dressings and soft tissue graft substitutes may help protect extraction socket bone grafts and provide better gingival contours. This randomized, controlled, multicenter, and double-blinded study was conducted to compare a control (wound dressing) and a test (soft tissue graft) substitute in nearly intact extraction sockets. Both test and control sockets were grafted with a xenogeneic bone graft. Graft containment, extraction socket soft tissue gap closure, gingival contour, and gingival thickness were examined over 16 weeks, at which time implants were placed. Healing was uneventful for both groups, and there was no significant difference (P < .05) between the times required to close the extraction socket soft tissue gap (~80% of sites closed by 8 weeks). Bone grafts were covered and contained longer in the test group (~4 weeks vs ~2 weeks), with less contour disruption out to 4 weeks; however, at implant placement, soft tissue contours in both groups were comparable, and soft tissue thicknesses were not significantly different.

American Academy of Periodontology best evidence consensus statement on the use of biologics in clinical practice.

A biologic is a therapeutic agent with biological activity that is administered to achieve an enhanced regenerative or reparative effect. The use of biologics has progressively become a core component of contemporary periodontal practice. However, some questions remain about their safety, indications, and effectiveness in specific clinical scenarios. Given their availability for routine clinical use and the existing amount of related evidence, the goal of this American Academy of Periodontology (AAP) best evidence consensus (BEC) was to provide a state-of-the-art, evidence-based perspective on the therapeutic application of autologous blood-derived products (ABPs), enamel matrix derivative (EMD), recombinant human platelet-derived growth factor BB (rhPDGF-BB), and recombinant human bone morphogenetic protein 2 (rhBMP-2). A panel of experts with extensive knowledge on the science and clinical application of biologics was convened. Three systematic reviews covering the areas of periodontal plastic surgery, treatment of infrabony defects, and alveolar ridge preservation/reconstruction and implant site development were conducted a priori and provided the foundation for the deliberations. The expert panel debated the merits of published data and exchanged experiential information to formulate evidence-based consensus statements and recommendations for clinical practice and future research. Based on an analysis of the current evidence and expert opinion, the panel concluded that the appropriate use of biologics in periodontal practice is generally safe and provides added benefits to conventional treatment approaches. However, therapeutic benefits and risks range based on the specific biologics used as well as patient-related local and systemic factors. Given the limited evidence available for some indications (e.g., gingival augmentation therapy, alveolar ridge preservation/reconstruction, and implant site development), future clinical studies that can expand the knowledge base on the clinical use of biologics in periodontal practice are warranted.

Randomized, controlled, clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation: A 6- to 8-year follow-up.

BACKGROUND: The purpose of this follow up study was to determine if a xenogeneic collagen matrix (CMX) is as effective as free gingival graft (FGG) in preventing further recession 6+ years following vestibuloplasty. METHODS: This study was a single-blind (examiner), randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (< 2 mm), associated with at least two, paired teeth. The study utilized a within subject treatment comparison to examine non-inferiority according to primary and secondary endpoints 6+ years after therapy. The original study primary efficacy endpoint was keratinized tissue width (KTw); however, in this report, prevention of recession (Rec) was also examined, along with traditional, secondary clinical measures, histopathology of mucosal biopsies and exploratory, patient reported outcomes (PROs) for pain and satisfaction. RESULTS: A total of 23 of the 30 original, study patients were available for 6 to 8-year postoperative assessment, and these patients were representative of the original patient population. For preventing further Rec, CMX was not inferior to FGG (ΔRec = -0.07 ± 1.26 mm for CMX and -0.17 ± 0.78 mm for FGG, P = 0.710). There were no adverse results observed, and histological assessment indicated normal, keratinized gingiva for both therapies. Tissue texture and color match to surrounding, native tissues were significantly better for CMX, and patients preferred CMX over FGG therapy. CONCLUSIONS: CMX appears to be a suitable substitute for FGG 6+ years after therapy.

Comparison of Er,Cr:YSGG laser to minimally invasive surgical technique in the treatment of intrabony defects: Six-month results of a multicenter, randomized, controlled study.

BACKGROUND: The purpose of this publication is to report on the six-month clinical results and patient-reported outcomes (PROs) comparing the surgical use of the erbium, chromium-doped: yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser (ERL) and minimally invasive surgical technique (MIST) for the treatment of intrabony defects in subjects with generalized periodontitis stage III, grade B. METHODS: Fifty-three adults (29 females and 24 males; aged 19 to 73 years) with 79 intrabony defects were randomized following scaling and root planing (SRP) to receive ERL monotherapy (n = 27) or MIST (n = 26). Recession, probing depth (PD), clinical attachment level (CAL), treatment time, and PROs were assessed and compared for each treatment group. Clinical measurements were recorded at baseline, 4 to 6 weeks following SRP, and 6 months following surgical therapy. RESULTS: The following primary and secondary outcome variables were non-inferior with the following margins: CAL with a non-inferiority margin of 0.6 mm (p = 0.05), PD with a non-inferiority margin of 0.5 mm (p = 0.05). Recession with a non-inferiority margin of 0.4 mm (p = 0.05). Faster procedure times were found for ERL (16.39 ± 6.21 minutes) versus MIST (20.17 ± 5.62 minutes), p = 0.0002. In the first 2 to 3 days of post-therapeutic diary outcomes, subjects reported less bruising, facial swelling, and use of ice pack for the ERL group. CONCLUSIONS: This is the first multicenter, randomized, masked, and controlled study demonstrating the ERL is not inferior to MIST in terms of clinical outcomes but is superior in PROs for the surgical treatment of intrabony defects.

Informed consent: what do patients really want to know?

PURPOSE: Although it is generally advised to provide patients with as much information as possible during the informed consent process, little is known about the amount and type of information that patients actually desire. The purpose of this study was to address this question. PATIENTS AND METHODS: We gave 212 patients (93 men and 119 women) presenting to an emergency clinic for oral surgery, ranging in age from 18 years to more than 50 years, a questionnaire containing 12 questions at their initial visit that asked them how much information they would like about the general and specific risks associated with the procedure. They were also asked when they would like to receive that information and whether they would like it in written form. RESULTS: Of the patients, 57% wanted to know about all complications, 33% wanted to know only about the most common complications, and 10% did not want to know anything about possible complications. The desire to know about complications increased along with their suggested frequency. Seventy-eight percent said they would like written as well as verbal information, and most wanted it provided before scheduling their operation and again just before undergoing it. The only difference between the responses from men and women was that significantly more men wanted to know about the risk of surgery not improving their symptoms and the risk of nerve damage. There was no relationship between the age of the patient and the responses given. CONCLUSION: A thorough informed consent process generally provides more information than most patients desire.

Efficacy of pre- and postirradiation hyperbaric oxygen therapy in the prevention of postextraction osteoradionecrosis: a systematic review.

PURPOSE: There is still considerable controversy regarding whether hyperbaric oxygen (HBO) therapy used preoperatively and postoperatively will prevent osteoradionecrosis in previously irradiated patients undergoing tooth extraction. The purpose of this systematic review was to evaluate the best evidence available in an attempt to find an answer to this question. MATERIALS AND METHODS: The literature search on Medline covered the period from January 1948 to March 2008. Included were randomized clinical trials, prospective studies without randomization, case-control studies, retrospective studies, and observational studies with and without control groups. This search retrieved 696 citations, which was reduced to 14 acceptable publications based on an assessment of methodologic quality. They included 1 randomized clinical trial, 8 cohort-controlled studies, and 5 observational studies. These were analyzed for radiation dose, type of radiation, use of adjunctive cancer treatments, number and location of extractions, method of extraction, HBO protocol, and use of adjunctive therapy besides HBO. RESULTS: Most of the studies had a small sample size, lacked specific inclusion and exclusion criteria, did not report the interval between radiation and extraction, and provided limited information on the method of extraction. There was also variation in HBO protocols, radiation dosage, the use of antibiotics, and the use of adjunctive cancer therapy. CONCLUSION: On the basis of the best available evidence, there is currently insufficient information to show that the use of HBO reduces the incidence of osteoradionecrosis in irradiated patients requiring tooth extraction.

Association of antimicrobial and clinical efficacy: periodontitis therapy with minocycline microspheres.

OBJECTIVE: The objective of this study was to investigate the association between the antimicrobial and clinical efficacy of minocycline hydrochloride microspheres when used adjunctively with scaling and root planing. METHODS: 127 subjects with moderate-to-advanced chronic periodontitis were randomly assigned to receive either minocycline microspheres plus scaling and root planing (n = 62) or scaling and root planing alone (n = 65). Deoxyribose nucleic acid analysis and clinical data were obtained at baseline and 30 days after treatment. End points included changes in the mean sum of red complex bacteria, pocket depth, number of deep pockets, bleeding on probing, and clinical attachment level from baseline to day 30. Regression analysis determined the association between microbiological and clinical efficacy. RESULTS: Minocycline microspheres plus scaling and root planing reduced pocket depth, the number of deep pockets and bleeding on probing, and increased clinical attachment level significantly more than scaling and root planing alone (p < 0.05). Comparing minocycline microspheres plus scaling and root planing with scaling and root planing alone, the number needed to treat for a 2 mm pocket depth reduction difference was 6.5. Pocket depth reduction correlated significantly with a decrease in the numbers and proportions of red complex bacteria. Minocycline microspheres significantly improved all clinical parameters compared to scaling and root planing alone. CONCLUSIONS: The addition of minocycline microspheres to scaling and root planing led to a greater reduction in the proportions and numbers of red complex bacteria. The reduction in pocket depth was significantly correlated with the reduction of the proportions and numbers of red complex bacteria. Additionally, there were statistically greater improvements in all clinical parameters examined.

Effects of caloric restriction on inflammatory periodontal disease.

OBJECTIVE: Dietary caloric restriction (CR) has been found to reduce systemic markers of inflammation and may attenuate the effects of chronic inflammatory conditions. The purpose of this study was to examine the effects of long-term CR on naturally occurring chronic inflammatory periodontal disease in a nonhuman primate model. METHODS: The effects of long-term CR on extent and severity of naturally occurring chronic periodontal disease, local inflammatory and immune responses, and periodontal microbiology, were evaluated in a cohort of 81 (35 female and 46 male; 13-40 y of age) rhesus monkeys (Macaca mulatta) with no previous exposure to routine oral hygiene. CR monkeys had been subjected to 30% CR for 13-17 y relative to control-fed (CON) animals starting at 3-5 y of age. RESULTS: Same sex CR and CON monkeys exhibited similar levels of plaque, calculus, and bleeding on probing. Among CON animals, males showed significantly greater periodontal breakdown, as reflected by higher mean clinical attachment level and periodontal probing depth scores, than females. CR males exhibited significantly less periodontal pocketing, lower IgG antibody response, and lower IL-8 and ss-glucuronidase levels compared to CON males, whereas CR females showed a lower IgG antibody response but comparable clinical parameters and inflammatory marker levels relative to CON females. Long-term CR had no demonstrable effect on the periodontal microbiota. CONCLUSION: Males demonstrated greater risk for naturally occurring periodontal disease than females. Long-term CR may differentially reduce the production of local inflammatory mediators and risk for inflammatory periodontal disease among males but not females.

Results from the Periodontitis and Vascular Events (PAVE) Study: a pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease.

BACKGROUND: In the Periodontitis and Vascular Events (PAVE) pilot study, periodontal therapy was provided as an intervention in a secondary cardiac event prevention model through five coordinated cardiac-dental centers. METHODS: Subjects were randomized to either community care or protocol provided scaling and root planing to evaluate effects on periodontal status and systemic levels of high-sensitivity C-reactive protein (hs-CRP). RESULTS: After 6 months, there was a significant reduction in mean probing depth and extent of 4- or 5-mm pockets. However, there were no significant differences in attachment levels, bleeding upon probing, or extent of subgingival calculus comparing subjects assigned to protocol therapy (n = 151) to those assigned to community care (n = 152). Using intent-to-treat analyses, there was no significant effect on serum hs-CRP levels at 6 months. However, 48% of the subjects randomized to community care received preventive or periodontal treatments. Secondary analyses demonstrated that consideration of any preventive or periodontal care (i.e., any treatment) compared to no treatment showed a significant reduction in the percentage of people with elevated hs-CRP (values >3 mg/l) at 6 months. However, obesity nullified the periodontal treatment effects on hs-CRP reduction. The adjusted odds ratio for hs-CRP levels >3 mg/l at 6 months for any treatment versus no treatment among non-obese individuals was 0.26 (95% confidence interval: 0.09 to 0.72), adjusting for smoking, marital status, and gender. CONCLUSION: This pilot study demonstrated the critical role of considering obesity as well as rigorous preventive and periodontal care in trials designed to reduce cardiovascular risk.

Peri-implantitis Treatment Using Er:YAG Laser and Bone Grafting. A Prospective Consecutive Case Series Evaluation: 1 Year Posttherapy.

An effective treatment regime for peri-implantitis (P-I) should include disinfection and regeneration of peri-implant tissues. Twenty consecutive patients exhibiting 23 P-I implants with 84 deep (≥ 6 mm) defects were treated using an Er:YAG laser for implant surface decontamination, removal of defect granulomatous tissues, and grafting therapy for bony defect resolution. Probing pocket defects (PPD) ≥ 6 mm (deep probing depths) before surgery were reduced on average to approximately 3.5 mm at 12 months. Probing depths < 6 mm (shallow probing depths) remained stable (mean PPD 3.2 mm at 12 months). Radiographs indicated PPD reductions were achieved along with peri-implant defect fill.

The effects of a calorie-reduced diet on periodontal inflammation and disease in a non-human primate model.

BACKGROUND: Low-calorie diets are commonplace for reducing body weight. However, no information is available on the effects of a reduced-calorie diet on periodontal inflammation and disease. The purpose of this study was to evaluate the clinical effects of a long-term calorie-restriction (CR) diet on periodontitis in an animal model of periodontitis. METHODS: Periodontitis was induced in 55 young, healthy, adult rhesus monkeys (Macaca mulatta) by tying 2.0 silk ligatures at the gingival margins of maxillary premolar/molar teeth. Animals on a CR diet (30% CR; N = 23) were compared to ad libitum diet controls (N = 32). Clinical measures, including the plaque index (PI), probing depth (PD), clinical attachment level (CAL), modified gingival index (GI), and bleeding on probing (BOP) were recorded at baseline and 1, 2, and 3 months after ligature placement. RESULTS: Significant effects of CR were observed on the development of inflammation and the progression of periodontal destruction in this model. Compared to controls, CR resulted in a significant reduction in ligature-induced GI (P <0.0001), BOP (P <0.0015), PD (P <0.0016), and CAL (P <0.0038). Periodontal destruction, as measured by CAL, progressed significantly more slowly in the CR animals than in the controls (P <0.001). CONCLUSIONS: These clinical findings are consistent with available evidence that CR has anti-inflammatory effects. Moreover, these experimental findings are the first observations, to the best of our knowledge, that CR dampens the inflammatory response and reduces active periodontal breakdown associated with an acute microbial challenge.

The Periodontitis and Vascular Events (PAVE) pilot study: recruitment, retention, and community care controls.

BACKGROUND: Population-based clinical and laboratory studies have reported findings providing support for a possible relationship between periodontal disease and cardiovascular disease. The Periodontitis and Vascular Events (PAVE) pilot study was conducted to investigate the feasibility of a randomized secondary prevention trial to test whether treatment of periodontal disease reduces the risk for cardiovascular disease. METHODS: Five clinical centers recruited participants who had documented coronary heart disease and met study criteria for periodontal disease. Eligible participants were randomized to receive periodontal therapy provided by the study or community dental care. Follow-up telephone calls and clinic visits were planned to alternate at 3-month intervals after randomization, with all participants followed until at least the 6-month clinic visit. Participants were followed for adverse events and periodontal and cardiovascular outcomes. RESULTS: A total of 303 participants were randomized. Recruitment that involved active participation of a cardiologist with responsibility for the patients worked best among the strategies used. Of those who had not withdrawn, 93% completed the 6-month contact. During follow-up, 11% of the 152 subjects in the community dental care group reported receiving periodontal therapy outside of the study. CONCLUSIONS: If appropriate recruitment strategies are used, this pilot study demonstrated that it is feasible to conduct a secondary prevention trial of periodontal therapy in patients who have had coronary heart disease. If a community dental care group is used, sample size estimation needs to take into account that a non-trivial proportion of participants in this group may receive periodontal therapy outside of the study.