Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies.

INTRODUCTION: Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage. METHODS AND ANALYSIS: We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at <24 weeks of gestation and an asymptomatic short cervix of ≤25 mm or cervical dilatation will be randomly allocated (1:1) to both trials on vaginal cerclage and standard treatment according to the current Dutch Society of Obstetrics and Gynaecology guideline (no cerclage). Permuted blocks sized 2 and 4 will be used to minimise the risk of disbalance. The primary outcome measure is PTB of <28 weeks. Analyses will be by intention to treat. The first trial is to demonstrate a risk reduction from 25% to 10% in the short cervix group, for which 194 patients need to be recruited. The second trial is to demonstrate a risk reduction from 80% to 35% in the dilatation group and will recruit 44 women. A cost-effectiveness analysis will be performed from a societal perspective. ETHICS AND DISSEMINATION: This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05968794.

Etiology, pathogenesis and treatment of peri-implantitis: A European perspective.

Peri-implantitis is a plaque-associated pathological condition occurring in tissues around dental implants. It is characterized by inflammation in the peri-implant mucosa and progressive loss of supporting bone. Over the last 30 years, peri-implantitis has become a major disease burden in dentistry. An understanding of the diagnosis, etiology and pathogenesis, epidemiology, and treatment of peri-implantitis must be a central component in undergraduate and postgraduate training programs in dentistry. In view of the strong role of European research in periodontology and implant dentistry, the focus of this review was to address peri-implantitis from a European perspective. One component of the work was to summarize new and reliable data on patients with dental implants to underpin the relevance of peri-implantitis from a population perspective. The nature of the peri-implantitis lesion was evaluated through results presented in preclinical models and evaluations of human biopsy material together with an appraisal of the microbiological characteristics. An overview of strategies and outcomes presented in clinical studies on nonsurgical and surgical treatment of peri-implantitis is discussed with a particular focus on end points of therapy and recommendations presented in the S3 level Clinical Practice Guideline for the prevention and treatment of peri-implant diseases.

Long-term outcomes and prognostic factors of surgical treatment of peri-implantitis - A retrospective study.

AIM: To evaluate long-term outcomes and prognostic factors of non-reconstructive surgical treatment of peri-implantitis. MATERIALS AND METHODS: One hundred forty-nine patients (267 implants) were surgically treated for peri-implantitis and followed for an average of 7.0 (SD: 3.6) years. The primary outcome was implant loss. Additional bone loss and surgical retreatment were secondary outcomes. Patient/implant characteristics, as well as clinical and radiographic parameters collected prior to initial surgery, were evaluated as potential predictors of implant loss. Flexible parametric survival models using restricted cubic spline functions were used; 5- and 10-year predicted rates of implant loss were calculated according to different scenarios. RESULTS: Fifty-three implants (19.9%) in 35 patients (23.5%) were lost during the observation period. Implant loss occurred after a mean period of 4.4 (SD: 3.0) years and was predicted by implant surface characteristics (modified surface; HR 4.5), implant length (HR 0.8 by mm), suppuration at baseline (HR 2.7) and disease severity (baseline bone loss: HR 1.2 by mm). Estimates of 5- and 10-year implant loss ranged from 1% (best prognostic scenario; initial bone loss <40% of implant length, turned implant surface and absence of suppuration on probing (SoP)) to 63% (worst prognostic scenario; initial bone loss ≥60% of implant length, modified implant surface and SoP) and from 3% to 89%, respectively. Surgical retreatment was performed at 65 implants (24.3%) in 36 patients (24.2%) after a mean time period of 4.5 (3.1) years. In all, 59.5% of implants showed additional bone loss, were surgically retreated or lost. CONCLUSIONS: Recurrence of disease is common following surgical treatment of peri-implantitis. The strongest predictor for implant loss was implant surface characteristics. Implant length as well as suppuration and disease severity at baseline were also relevant factors.

Decontamination of biofilm-contaminated implant surfaces: An in vitro evaluation.

OBJECTIVES: The aim of the present study was to evaluate the cleaning efficacy of two mechanical and two chemical protocols in the decontamination of implant surfaces. METHODS: In total, 123 commercially available implants were mounted in plastic models mimicking peri-implant circumferential intra-bony defects. A multispecies biofilm was grown on implant surfaces. Mechanical (air-polishing (AP), rotating titanium brush (TiB)) and chemical decontamination (alkaline electrolyzed water, N-acetyl-L-cysteine) protocols were used. Cleaning efficacy in terms of residual biofilm area, chemical surface properties, and bacterial counts were analyzed by scanning electron microscopy, energy-dispersive X-ray spectroscopy, and quantitative polymerase chain reaction. RESULTS: Surface decontamination protocols including use of an AP device or a rotating TiB were superior in terms of biofilm removal and in reducing atomic% of Carbon on implant surfaces when compared to methods restricted to wiping with gauze. The use of chemical agents as adjuncts to the mechanical cleaning protocols provided no relevant overall benefit over saline. No treatment modality, however, resulted in complete biofilm removal. CONCLUSION: Air-polishing and rotating TiB were more effective implant surface decontamination protocols than wiping with gauzes. Use of chemical agents did not improve cleaning efficacy.

Factors influencing outcomes of surgical therapy of peri-implantitis: A secondary analysis of 1-year results from a randomized clinical study.

AIM: To identify predictors of treatment outcomes following surgical therapy of peri-implantitis. MATERIALS AND METHODS: We performed a secondary analysis of data from a randomized controlled trial (RCT) comparing access flap with or without bone replacement graft. Outcomes at 12 months were probing pocket depth (PPD), bleeding on probing (BOP), soft-tissue recession (REC) and marginal bone level (MBL) change. Multilevel regression analyses were used to identify predictors. We also built an explanatory model for residual signs of inflammation. RESULTS: Baseline PPD was the most relevant predictor, showing positive associations with final PPD, REC and MBL gain, and negative association with probability of pocket closure. Smokers presented higher residual PPD. Absence of keratinized mucosa at baseline increased the probability of BOP but was otherwise not indicative of outcomes. Plaque at 6 weeks was detrimental in terms of residual PPD and BOP. Treatment allocation had an effect on REC. Final BOP was explained by residual PPD ≥6 mm and plaque at more than two sites. CONCLUSIONS: Baseline PPD was the most relevant predictor of the outcomes of surgical therapy of peri-implantitis. Pocket closure should be a primary goal of treatment. Bone replacement grafts may be indicated in aesthetically demanding cases to reduce soft-tissue recession. The importance of smoking cessation and patient-performed plaque control is also underlined.

Surface decontamination of explanted peri-implantitis-affected implants.

AIM: The present study aimed at evaluating the effect of air-polishing (AP) and a combination of AP and alkaline electrolysed water (AEW) in surface decontamination of explanted peri-implantitis-affected implants. MATERIALS AND METHODS: Twenty-five patients with 34 dental implants scheduled for explantation due to severe peri-implantitis were included. Following implant removal, the apical part of each implant was embedded in acrylic blocks. Implants were randomly allocated to surface decontamination using AP with or without AEW. Four implants were left untreated and used as negative controls. Specimens were analysed using scanning electron microscopy (SEM) and energy-dispersive x-ray spectroscopy (EDS). Area of residual bacteria was the primary outcome. RESULTS: SEM analysis revealed that both treatment protocols were effective in biofilm removal and only small proportions of target areas of the implants showed residual bacterial or mineralized deposits. Although differences between the treatment protocols were small, implant thread loci (top/flank/valley), zones of the implant (apical/middle/coronal), implant surface characteristics and gender influenced the results. In addition, EDS analysis showed that zones influenced the atomic% of carbon and calcium and that implant surface characteristics affected the atomic% of titanium. CONCLUSIONS: AP, with or without AEW, is an effective method in removing biofilm from peri-implantitis-affected implants.

Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report.

AIM: Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). MATERIALS AND METHODS: This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. RESULTS: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). CONCLUSIONS: The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

Relevant domains, core outcome sets and measurements for implant dentistry clinical trials: The Implant Dentistry Core Outcome Set and Measurement (ID-COSM) international consensus report.

AIM: Lack of consistently reported outcomes limits progress in evidence-based implant dentistry and quality of care. The objective of this initiative was to develop a core outcome set (COS) and measurements for implant dentistry clinical trials (ID-COSM). MATERIALS AND METHODS: This Core Outcome Measures in Effectiveness Trials (COMET)-registered international initiative comprised six steps over 24 months: (i) systematic reviews of outcomes reported in the last 10 years; (ii) international patient focus groups; (iii) a Delphi project with a broad range of stakeholders (care providers, clinical researchers, methodologists, patients and industry representatives); (iv) expert group discussions organizing the outcomes in domains using a theoretical framework and identifying the COSs; (v) identification of valid measurement systems to capture the different domains and (vi) final consensus and formal approval involving experts and patients. The methods were modified from the best practice approach following the Outcome Measures in Rheumatoid Arthritis Clinical Trial and COMET manuals. RESULTS: The systematic reviews and patient focus groups identified 754 (665 + 89, respectively) relevant outcome measures. After elimination of redundancies and duplicates, 111 were formally assessed in the Delphi project. By applying pre-specified filters, the Delphi process identified 22 essential outcomes. These were reduced to 13 after aggregating alternative assessments of the same features. The expert committee organized them into four core outcome areas: (i) pathophysiology, (ii) implant/prosthesis lifespan, (iii) life impact and (iv) access to care. In each area, core outcomes were identified to capture both the benefits and harms of therapy. Mandatory outcome domains included assessment of surgical morbidity and complications, peri-implant tissue health status, intervention-related adverse events, complication-free survival and overall patient satisfaction and comfort. Outcomes deemed mandatory in specific circumstances comprised function (mastication, speech, aesthetics and denture retention), quality of life, effort for treatment and maintenance and cost effectiveness. Specialized COSs were identified for bone and soft-tissue augmentation procedures. The validity of measurement instruments ranged from international consensus (peri-implant tissue health status) to early identification of important outcomes (patient-reported outcomes identified by the focus groups). CONCLUSIONS: The ID-COSM initiative reached a consensus on a core set of mandatory outcomes for clinical trials in implant dentistry and/or soft tissue/bone augmentation. Adoption in future protocols and reporting on the respective domain areas by currently ongoing trials will contribute to improving evidence-informed implant dentistry and quality of care.

Molecular mechanisms underlying adverse effects of dexamethasone and betamethasone in the developing cardiovascular system.

Antenatal glucocorticoids accelerate fetal lung maturation and reduce mortality in preterm babies but can trigger adverse effects on the cardiovascular system. The mechanisms underlying off-target effects of the synthetic glucocorticoids mostly used, Dexamethasone (Dex) and Betamethasone (Beta), are unknown. We investigated effects of Dex and Beta on cardiovascular structure and function, and underlying molecular mechanism using the chicken embryo, an established model system to isolate effects of therapy on the developing heart and vasculature, independent of effects on the mother or placenta. Fertilized eggs were treated with Dex (0.1 mg kg-1 ), Beta (0.1 mg kg-1 ), or water vehicle (Control) on embryonic day 14 (E14, term = 21 days). At E19, biometry, cardiovascular function, stereological, and molecular analyses were determined. Both glucocorticoids promoted growth restriction, with Beta being more severe. Beta compared with Dex induced greater cardiac diastolic dysfunction and also impaired systolic function. While Dex triggered cardiomyocyte hypertrophy, Beta promoted a decrease in cardiomyocyte number. Molecular changes of Dex on the developing heart included oxidative stress, activation of p38, and cleaved caspase 3. In contrast, impaired GR downregulation, activation of p53, p16, and MKK3 coupled with CDK2 transcriptional repression linked the effects of Beta on cardiomyocyte senescence. Beta but not Dex impaired NO-dependent relaxation of peripheral resistance arteries. Beta diminished contractile responses to potassium and phenylephrine, but Dex enhanced peripheral constrictor reactivity to endothelin-1. We conclude that Dex and Beta have direct differential detrimental effects on the developing cardiovascular system.

OPtimal TIming of antenatal COrticosteroid administration in pregnancies complicated by early-onset fetal growth REstriction (OPTICORE): study protocol of a multicentre, retrospective cohort study.

INTRODUCTION: Early-onset fetal growth restriction (FGR) requires timely, often preterm, delivery to prevent fetal hypoxia causing stillbirth or neurologic impairment. Antenatal corticosteroids (CCS) administration reduces neonatal morbidity and mortality following preterm birth, most effectively when administered within 1 week preceding delivery. Optimal timing of CCS administration is challenging in early-onset FGR, as the exact onset and course of fetal hypoxia are unpredictable. International guidelines do not provide a directive on this topic. In the Netherlands, two timing strategies are commonly practiced: administration of CCS when the umbilical artery shows (A) a pulsatility index above the 95thh centile and (B) absent or reversed end-diastolic velocity (a more progressed disease state). This study aims to (1) use practice variation to compare CCS timing strategies in early-onset FGR on fetal and neonatal outcomes and (2) develop a dynamic tool to predict the time interval in days until delivery, as a novel timing strategy for antenatal CCS in early-onset FGR. METHODS AND ANALYSIS: A multicentre, retrospective cohort study will be performed including pregnancies complicated by early-onset FGR in six tertiary hospitals in the Netherlands in the period between 2012 and 2021 (estimated sample size n=1800). Main exclusion criteria are multiple pregnancies and fetal congenital or genetic abnormalities. Routinely collected data will be extracted from medical charts. Primary outcome for the comparison of the two CCS timing strategies is a composite of perinatal, neonatal and in-hospital mortality. Secondary outcomes include the COSGROVE core outcome set for FGR. A multivariable, mixed-effects model will be used to compare timing strategies on study outcomes. Primary outcome for the dynamic prediction tool is 'days until birth'. ETHICS AND DISSEMINATION: The need for ethical approval was waived by the Ethics Committee (University Medical Center Utrecht). Results will be published in open-access, peer-reviewed journals and disseminated by presentations at scientific conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05606497.

The adjunctive effect of a resorbable membrane to a xenogeneic bone replacement graft in the reconstructive surgical therapy of peri-implantitis: A randomized clinical trial.

AIM: To evaluate the potential adjunctive effect of a resorbable collagen membrane covering a xenogeneic bone replacement graft in the reconstructive surgical therapy of peri-implantitis. MATERIALS AND METHODS: Forty-three patients (43 implants) diagnosed with peri-implantitis associated with intra-bony defects were treated with a surgical reconstructive approach that included a xenogeneic bone substitute material. Additionally, resorbable collagen membranes were placed over the grafting material at sites randomly allocated to the test group; conversely, no membranes were placed in the control group. Clinical outcomes, namely probing pocket depth (PPD), bleeding and suppuration on probing (BoP and SoP), marginal mucosal level (REC) and keratinized mucosa width (KMW), were recorded at baseline and 6 and 12 months after surgery. Radiographic marginal bone levels (MBLs) and patient-reported outcomes (PROs) were assessed at baseline and 12 months. A composite outcome (success) was evaluated at 12 months, which included the absence of BoP/SoP, PPD ≤5 mm and reduction of buccal marginal mucosal level (buccal REC) of ≤1 mm. RESULTS: At 12 months, no implants were lost and treatment success was observed at 36.8% and 45.0% of implants in the test and control groups, respectively (p = .61). Similarly, there were no significant differences between groups in terms of changes of PPD, BoP/SoP, KMW, MBL or buccal REC. Post-surgical complications were observed in the test group only (e.g., soft tissue dehiscence, exposure of particulate bone graft and/or resorbable membrane). Longer surgical times (~10 min; p < .05) and higher levels of self-reported pain at 2 weeks (p < .01) were observed in the test group. CONCLUSIONS: This study failed to demonstrate the presence of added clinical or radiographic benefits of the use of a resorbable membrane to cover a bone substitute material within the reconstructive surgical therapy of peri-implantitis associated with intra-bony defects.

Combined Statin and Glucocorticoid Therapy for the Safer Treatment of Preterm Birth.

BACKGROUND: Prematurity is strongly associated with poor respiratory function in the neonate. Rescue therapies include treatment with glucocorticoids due to their anti-inflammatory and maturational effects on the developing lung. However, glucocorticoid treatment in the infant can increase the risk of long-term cardiovascular complications including hypertension, cardiac, and endothelial dysfunction. Accumulating evidence implicates a molecular link between glucocorticoid excess and depletion of nitric oxide (NO) bioavailability as a mechanism underlying the detrimental effects of postnatal steroids on the heart and circulation. Therefore, combined glucocorticoid and statin therapy, by increasing NO bioavailability, may protect the developing cardiovascular system while maintaining beneficial effects on the lung. METHODS: We investigated combined glucocorticoid and statin therapy using an established rodent model of prematurity and combined experiments of cardiovascular function in vivo, with those in isolated organs as well as measurements at the cellular and molecular levels. RESULTS: We show that neonatal glucocorticoid treatment increases the risk of later cardiovascular dysfunction in the offspring. Underlying mechanisms include decreased circulating NO bioavailability, sympathetic hyper-reactivity, and NO-dependent endothelial dysfunction. Combined neonatal glucocorticoid and statin therapy protects the developing cardiovascular system by normalizing NO and sympathetic signaling, without affecting pulmonary maturational or anti-inflammatory effects of glucocorticoids. CONCLUSIONS: Therefore, combined glucocorticoid and statin therapy may be safer than glucocorticoids alone for the treatment of preterm birth.

Onset of periodontitis - a registry-based cohort study.

OBJECTIVES: The present retrospective registry-based cohort study aimed to identify parameters associated with the onset of periodontitis in young adults. MATERIAL AND METHODS: A total of 345 Swedish subjects were clinically examined at age 19 years (as part of an epidemiological survey) and then followed up to 31 years through the Swedish Quality Registry for Caries and Periodontal diseases (SKaPa). The registry data including periodontal parameters were obtained for the period 2010-2018 (23-31 years). Logistic regression and survival models were used to identify risk factors for periodontitis (PPD ≥6 mm at ≥2 teeth). RESULTS: The incidence of periodontitis during the 12-year observation period was 9.8%. Cigarette smoking (modified pack-years; HR 2.35, 95%CI 1.34-4.13) and increased probing pocket depth (number of sites with PPD 4-5 mm; HR 1.04, 95%CI 1.01-1.07) at 19 years were risk factors for periodontitis in subsequent young adulthood. No statistically significant association was identified for gender, snuff use, plaque and marginal bleeding scores. CONCLUSION: Cigarette smoking and increased probing pocket depth (≥4 mm) in late adolescence (19 years) were relevant risk factors for periodontitis in young adulthood. CLINICAL RELEVANCE: Our study identified cigarette smoking and increased probing depth in late adolescence as relevant risk factors of periodontitis in young adulthood. Preventive programs should therefore consider both cigarette smoking and probing pocket depths in their risk assessment.

Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial.

BACKGROUND: The aim of this study was to evaluate clinical and patient-reported outcomes following surgical root coverage at RT1 gingival recession defects at mandibular incisors, using either a conventional free gingival graft (FGG) or a modified FGG (ModFGG). METHODS: Total of 30 patients with RT1 gingival recessions at mandibular incisors were enrolled and randomly allocated to either a control (FGG) or test group (ModFGG). Evaluations of clinical changes (recession depth, height of keratinized tissue) and patient satisfaction were performed over a follow-up period of 12 months. Post-surgical changes of keratinized tissue height (shrinkage) were assessed from 1 month and onward. RESULTS: ModFGG resulted in more pronounced root coverage at 1 year compared to FGG (91.8% vs. 60.7%, p < 0.001). Height of keratinized tissue was improved by 4.2 and 2.2 mm (p < 0.001), respectively, with significantly less shrinkage in ModFGG. Post-surgical morbidity was significantly lower for ModFGG at 2 weeks and patient satisfaction was significantly higher 12 months after treatment (9.1 vs. 5.4; p < 0.001). CONCLUSIONS: ModFGG represents a valid approach for the management of RT1 recession defects at mandibular incisors. The technique is superior to traditional FGG in terms of root coverage, the gain of keratinized tissue height, and patient satisfaction.

Furcation involvement and tooth loss: A registry-based retrospective cohort study.

AIM: This registry-based retrospective cohort study aimed to evaluate the impact of furcation status on the risk for molar loss. MATERIALS AND METHODS: Subjects with and without furcation involvement (FI) in 2010/2011 were identified in a nationwide registry in Sweden (age- and gender-matched sample: 381,450 subjects; 2,374,883 molars). Data on dental and periodontal status were extracted for the subsequent 10-year period. Impact of FI (at baseline or detected during follow-up) on molar loss (i.e., tooth extraction) was evaluated through multilevel logistic regression and survival analyses. RESULTS: FI had a significant impact on molar loss. FI degrees 2 and 3 resulted in adjusted risk ratios of 1.67 (95% confidence interval [CI] 1.63-1.71) and 3.30 (95% CI 3.18-3.43), respectively. Following the first detection of deep FI (degrees 2-3), estimated survival decreased by 4% at 5 years and 8% at 10 years. In addition to FI, endodontic status and probing depth were relevant risk factors for molar loss. CONCLUSIONS: Furcation status had a clinically relevant impact on the risk for molar loss. Following first detection of deep FI, however, the decline in molar survival was minor.

Efficacy of access flap and pocket elimination procedures in the management of peri-implantitis: A systematic review and meta-analysis.

AIM: To evaluate the efficacy of access flap and pocket elimination procedures in the surgical treatment of peri-implantitis. MATERIALS AND METHODS: Systematic electronic searches (Central/MEDLINE/EMBASE) up to March 2022 were conducted to identify prospective clinical studies evaluating surgical therapy (access flap or pocket elimination procedures) of peri-implantitis. Primary outcome measures were reduction of probing depth (PD) and bleeding on probing (BOP). Risk of bias was evaluated according to study design. Meta-analysis and meta-regression were performed. Results were expressed as standardized mean effect with 95% confidence interval (CI). RESULTS: Evidence from studies directly comparing surgical with non-surgical therapy is lacking. Based on pre-post data originating from 13 prospective patient cohorts, pronounced reductions of PD (standardized mean effect: 2.2 mm; 95% CI 1.8-2.7) and BOP% (27.0; 95% CI 19.8-34.2) as well as marginal bone level gain (0.2 mm; 95% CI -0.0 to 0.5) were observed at evaluation time points ranging from 1 to 5 years. Wide prediction intervals suggested a high degree of heterogeneity. Reduction of mean PD increased by 0.7 mm (95% CI 0.5-0.9) for every millimetre in increase of mean PD at baseline. During the follow-up period ranging from 1 to 5 years, disease recurrence occurred frequently and implant loss was not uncommon. CONCLUSIONS: Access flap and pocket elimination surgery are effective procedures in the management of peri-implantitis, although rates of disease recurrence during 5 years were high. Treatment outcomes were affected by baseline conditions.

Prevention and management of peri-implant mucositis and peri-implantitis: A systematic review of outcome measures used in clinical studies in the last 10 years.

OBJECTIVES: To evaluate outcome measures, methods of assessment, and analysis in clinical studies on the prevention and management of peri-implant mucositis and peri-implantitis. METHODS: Systematic electronic searches (CENTRAL/MEDLINE/SCOPUS) up to April 2021 were conducted to identify longitudinal clinical studies with ≥10 patients on either the prevention or management of peri-implant diseases. Outcome measures of this analysis were the choice of outcome measures, methods of assessment, and analytical methods. Risk of bias was evaluated according to study design. Data were extracted into evidence tables and outcomes were analysed in a descriptive manner. RESULTS: The analysis of the 159 selected studies revealed that probing pocket depth (PPD) and bleeding/suppuration on probing (BOP) were reported in 89% and 87% of all studies, respectively. Additional outcome measures included plaque scores (reported in 64% of studies), radiographic outcomes (49%), soft tissue dimensions (34%), and composite outcomes (26%). Adverse events (8%) and patient-reported outcomes (6%) were only rarely mentioned. A primary outcome measure was clearly defined only in 36% of studies. Data on PPD, radiographic outcomes, and soft tissue dimensions were primarily reported as mean values and rarely as frequency distributions. For radiographic outcomes and soft tissue dimensions, it was frequently unclear how clustered data were handled. CONCLUSIONS: PPD and BOP were routinely reported in studies on the prevention and management of peri-implant mucositis and peri-implantitis, while composite outcomes, adverse events, and patient-reported outcomes were only infrequently described.

Prevention and management of peri-implant mucositis and peri-implantitis: A systematic review of outcome measures used in clinical studies in the last 10 years.

OBJECTIVES: To evaluate outcome measures, methods of assessment, and analysis in clinical studies on the prevention and management of peri-implant mucositis and peri-implantitis. METHODS: Systematic electronic searches (CENTRAL/MEDLINE/SCOPUS) up to April 2021 were conducted to identify longitudinal clinical studies with ≥10 patients on either the prevention or management of peri-implant diseases. Outcome measures of this analysis were the choice of outcome measures, methods of assessment, and analytical methods. Risk of bias was evaluated according to study design. Data were extracted into evidence tables and outcomes were analysed in a descriptive manner. RESULTS: The analysis of the 159 selected studies revealed that probing pocket depth (PPD) and bleeding/suppuration on probing (BOP) were reported in 89% and 87% of all studies, respectively. Additional outcome measures included plaque scores (reported in 64% of studies), radiographic outcomes (49%), soft tissue dimensions (34%), and composite outcomes (26%). Adverse events (8%) and patient-reported outcomes (6%) were only rarely mentioned. A primary outcome measure was clearly defined only in 36% of studies. Data on PPD, radiographic outcomes, and soft tissue dimensions were primarily reported as mean values and rarely as frequency distributions. For radiographic outcomes and soft tissue dimensions, it was frequently unclear how clustered data were handled. CONCLUSIONS: PPD and BOP were routinely reported in studies on the prevention and management of peri-implant mucositis and peri-implantitis, while composite outcomes, adverse events, and patient-reported outcomes were only infrequently described.

Scientific rationale for study: In 2012, recommendations on study design, key outcome measures, and reporting in clinical studies on the prevention and management of peri-implant diseases were presented. We aimed to evaluate how these recommendations were adapted and utilized in relevant studies published during the last decade. Principal findings: Recommendations on outcome measures and reporting in clinical studies on the prevention and management of peri-implant mucositis and peri-implantitis were only partially followed. Practical implications: When evaluating the evidence on the prevention and management of peri-implant diseases, the clinician should be aware of the limitations in terms of choice of outcome measures and data reporting.

Occurrence of complications in patients restored with implants.

OBJECTIVES: To determine the occurrence and clustering of complications in subjects restored with fixed implant-supported prostheses. METHODS: In the present retrospective case series, 241 subjects treated at one clinical centre and provided with 729 implants were included. A clinical and radiographic examination was performed after a mean follow-up period of 4.8 ± 2.0 years. Additional information on occurrence of technical (chipping, loss of retention, fracture of components) and biological complications (marginal bone loss, implant loss) during follow-up was extracted from patient records. For each type of complication and complications overall, regression analyses were performed to identify potential risk factors. Cox regression analyses were used to evaluate time to event for implant loss and technical complications. RESULTS: In all, 30% of the 241 patients presented with at least one complication of technical and/or biological character during the follow-up period. Technical complications affected 19.5% of subjects, while 14.1% presented with marginal bone loss >2 mm. Implant loss occurred in 4.6% of subjects. While technical complications were noted already early during the maintenance period (<1200 days), implant loss typically occurred during a later phase. A small subgroup of subjects (7.9%) experienced more than one type of complication. CONCLUSIONS: Complications occurred frequently and the most common type of complication was of technical character. Technical and biological complications occurred independently of each other.

Reconstructive surgical therapy of peri-implantitis: A multicenter randomized controlled clinical trial.

OBJECTIVE: To evaluate the potential benefit of the use of a bone substitute material in the reconstructive surgical therapy of peri-implantitis. METHODS: In this multicenter randomized clinical trial, 138 patients (147 implants) with peri-implantitis were treated surgically, randomized by coin toss to either a control (access flap surgery) or a test group (reconstructive surgery using bone substitute material). Clinical assessments, including probing pocket depth (PPD), bleeding and suppuration on probing (BOP & SOP) as well as soft tissue recession (REC), were recorded at baseline, 6 and 12 months. Marginal bone levels (MBL), measured on intra-oral radiographs, and patient-reported outcomes (PROs) were recorded at baseline and 12 months. No blinding to group allocation was performed. The primary outcome at 12 months was a composite measure including (i) implant not lost, (ii) absence of BOP/SOP at all aspects, (iii) PPD ≤5 mm at all aspects and (iv) ≤1 mm recession of mucosal margin on the buccal aspect of the implant. Secondary outcomes included (i) changes of MBL, (ii) changes of PPD, BOP%, and buccal KM, (iii) buccal REC and (iv) patient-reported outcomes. RESULTS: During follow-up, four implants (one in the test group, three in the control group) in four patients were removed due to disease progression. At 12 months, a total of 69 implants in the test and 68 implants in the control group were examined. Thus, 16.4% and 13.5% of implants in the test and control group, respectively, met all predefined criteria of the composite outcome. PPD reduction and MBL gain were 3.7 mm and about 1.0 mm in both groups. Reduction in mean BOP% varied between 45% (test) and 50% (control), without significant differences between groups. Buccal REC was less pronounced in the test group (M = 0.7, SD = 0.9 mm) when compared to controls (M = 1.1, SD = 1.5 mm). PROs were favorable in both groups without significant differences. One case of allergic reaction to the antibiotic therapy was recorded. No other adverse events were noted. CONCLUSIONS: Surgical therapy of peri-implantitis effectively improved the clinical and radiographic status at 12 months. While the use of a bone substitute material did not improve reductions of PPD and BOP, buccal REC was less pronounced in the test group. Patient satisfaction was high in both groups.