Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial.
ABSTRACT: BACKGROUND:Periodontal intrabony defects are usually treated surgically with the aim of increasing attachment and bone levels and reducing risk of progression. However, recent studies have suggested that a minimally invasive non-surgical therapy (MINST) leads to considerable clinical and radiographic defect depth reductions in intrabony defects. The aim of this study is to compare the efficacy of a modified MINST approach with a surgical approach (modified minimally invasive surgical therapy, M-MIST) for the treatment of intrabony defects. METHODS:This is a parallel-group, single-centre, examiner-blind non-inferiority randomised controlled trial with a sample size of 66 patients. Inclusion criteria are age 25-70, diagnosis of periodontitis stage III or IV (grades A to C), presence of ??1 'intrabony defect' with probing pocket depth (PPD) >?5?mm and intrabony defect depth???3?mm. Smokers and patients who received previous periodontal treatment to the study site within the last 12?months will be excluded. Patients will be randomly assigned to either the modified MINST or the M-MIST protocol and will be assessed up to 15?months following initial therapy. The primary outcome of the study is radiographic intrabony defect depth change at 15?months follow-up. Secondary outcomes are PPD and clinical attachment level change, inflammatory markers and growth factors in gingival crevicular fluid, bacterial detection, gingival inflammation and healing (as measured by geometric thermal camera imaging in a subset of 10 test and 10 control patients) and patient-reported outcomes. DISCUSSION:This study will produce evidence about the clinical efficacy and potential applicability of a modified MINST protocol for the treatment of periodontal intrabony defects, as a less invasive alternative to the use of surgical procedures. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03797807. Registered on 9 January 2019.
Project description:Purpose:The modified minimally invasive surgical technique (M-MIST) has been successfully employed to achieve periodontal regeneration. Platelet-rich fibrin (PRF) is known to enhance wound healing through the release of growth factors. This study aimed to observe the outcomes of periodontal surgery when M-MIST was used with or without PRF for the treatment of isolated intrabony defects. Methods:This randomized clinical trial was conducted on 36 systemically healthy patients, who had chronic periodontitis associated with a single-site buccal probing pocket depth (PPD) and clinical attachment level of ?5 mm. Patients were randomly divided into 2 groups: the test group treated with M-MIST and PRF, and the control group treated with M-MIST alone. The primary periodontal parameters analyzed were PPD, relative attachment level (RAL), and relative gingival margin level. The radiographic parameters analyzed were change in alveolar crest position (C-ACP), linear bone growth (LBG), and percentage bone fill (%BF). Patients were followed up to 6 months post-surgery. Results:Intragroup comparisons at 3 and 6 months showed consistently significant improvements in PPD and RAL in both the groups. In intergroup comparisons, the improvement in PPD reduction, gain in RAL, and the level of the gingival margin was similar in both groups at 3 and 6 months of follow-up. Furthermore, an intergroup comparison of radiographic parameters also demonstrated similar improvements in C-ACP, LBG, and %BF at 6 months of follow-up. Conclusions:M-MIST with or without PRF yielded comparable periodontal tissue healing in terms of improvements in periodontal and radiographic parameters. Further investigation is required to confirm the beneficial effects of PRF with M-MIST. Trial Registration:ClinicalTrials.gov Identifier: NCT03169920.
Project description:Background:There are no authoritative meta-analyses and no clear quantitative assessments available estimating effects of open flap debridement (OFD) combined with platelet-rich fibrin (PRF) or platelet-rich plasma (PRP) over and above that of OFD. This study evaluated the actual quantitative mean gain for various clinical (clinical attachment level [CAL], probing pocket depth [PPD] and gingival marginal level [GML]) and radiographic (intrabony defect depth [IBD]) parameters of Platelet Concentrates- PCs (PRP/PRF) as sole grafting material along with OFD and OFD alone in the treatment of intrabony defects. Materials and Methods:A detailed electronic search was carried out in PUBMED/MEDLINE, COCHRANE, EBSCOHOST, and Google Scholar databases by unifying related search terms with additional hand searches in select specialty journals up to May 2017. The eligibility criteria included human randomized clinical trials, either of a parallel group or a split-mouth design with follow-up period of at least 6 months. Periodontal intrabony defects with radiographic IBD ≥3 mm with corresponding CAL ≥5 mm were included. For the meta-analysis, the inverse variance method was used in fixed- or random-effect models. Results:Actual quantitative mean gains were calculated for OFD with PRF/PRP (CAL = 1.1 mm, IBD = 1.68 mm, PPD = 0.97 mm and GML = 0.48 mm) over and above that of OFD alone. Conclusion:Because of very high heterogeneity, the results may not be dependable. Apart from gains in radiographic bone fill, all other periodontal clinical parameters showed negligible gains. Using PRF technologies in periodontal intrabony defects may not be of great clinical significance over and above that of OFD alone, the effect sizes are also not large enough.
Project description:Treatment of intrabony periodontal defects with a combination of a natural bone mineral (NBM) and guided tissue regeneration (GTR) has been shown to promote periodontal regeneration in intrabony defects. In certain clinical situations, the teeth presenting intrabony defects are located at close vicinity of the resorbed alveolar ridge. In these particular cases, it is of clinical interest to simultaneously reconstruct both the intrabony periodontal defect and the resorbed alveolar ridge, thus allowing insertion of endosseous dental implants. The aim of the present study was to present the clinical and histological results obtained with a new surgical technique designed to simultaneously reconstruct the intrabony defect and the adjacently located resorbed alveolar ridge. Eight patients with chronic advanced periodontitis displaying intrabony defects located in the close vicinity of resorbed alveolar ridges were consecutively enrolled in the study. After local anesthesia, mucoperiosteal flaps were raised, the granulation tissue removed, and the roots meticulously scaled and planed. A subepithelial connective tissue graft was harvested from the palate and sutured to the oral flap. The intrabony defect and the adjacent alveolar ridge were filled with a NBM and subsequently covered with a bioresorbable collagen membrane (GTR). At 11-20 months (mean, 13.9+/-3.9 months) after surgery, implants were placed, core biopsies retrieved, and histologically evaluated. Mean pocket depth reduction measured 3.8+/-1.7 mm and mean clinical attachment level gain 4.3+/-2.2 mm, respectively. Reentry revealed in all cases a complete fill of the intrabony component and a mean additional vertical hard tissue gain of 1.8+/-1.8 mm. The histologic evaluation indicated that most NBM particles were surrounded by bone. Mean new bone and mean graft area measured 17.8+/-2.8% and 32.1+/-8.3%, respectively. Within their limits, the present findings indicate that the described surgical approach may be successfully used in certain clinical cases to simultaneously treat intrabony defects and to reconstruct the resorbed alveolar ridge.
Project description:OBJECTIVE:Periodontal disease is an inflammatory disorder with widespread morbidities involving both oral and systemic health. The primary goal of periodontal treatment is the regeneration of the lost or diseased periodontium. In this study, we retrospectively examined feasibility and safety of reconstructing the periodontal intrabony defects with autologous periodontal ligament progenitor (PDLP) implantation in three patients. MATERIALS AND METHODS:In this retrospective pilot study, we treated 16 teeth with at least one deep intrabony defect of probing depth (PD) > OR = 6 mm with PDLP transplantation and evaluated clinical outcome measures in terms of probing depth, gingival recession and attachment gain for a duration of 32-72 months. Furthermore, we compare PDLPs with standard PDL stem cells (PDLSCs) and confirmed that PDLPs possessed progenitor characters. RESULTS:Clinical examination indicated that transplantationof PDLPs may provide therapeutic benefit for the periodontal defects. All treated patients showed no adverse effects during the entire course of follow up. We also found that PDLPs were analogous to PDLSCs in terms of high proliferation, expression of mesenchymal surface molecules, multipotent differentiation, and in vivo tissue regain. However, PDLPs failed to express scleraxis, a marker of tendon, as seen in PDLSCs. CONCLUSIONS:This study demonstrated clinical and experimental evidences supporting a potential efficacy and safety of utilizing autologous PDL cells in the treatment of human periodontitis.
Project description:The aim of this retrospective case series was to evaluate the clinical efficacy of nanohydroxyapatite powder (NHA) in combination with polylactic acid/polyglycolic acid copolymer (PLGA) as a bone replacement graft in the surgical treatment of intrabony periodontal defects. Medical charts were screened following inclusion and exclusion criteria. Periodontal parameters and periapical radiographs taken before surgery and at 12-month follow-up were collected. Intra-group comparisons were performed using a two-tailed Wilcoxon signed-rank test. Twenty-five patients (13 males, 12 females, mean age 55.1 ± 10.5 years) were included in the final analysis. Mean probing depth (PD) and clinical attachment level (CAL) at baseline were 8.32 ± 1.41 mm and 9.96 ± 1.69 mm, respectively. Twelve months after surgery, mean PD was 4.04 ± 0.84 mm and CAL was 6.24 ± 1.71 mm. Both PD and CAL variations gave statistically significant results (p < 0.00001). The mean radiographic defect depth was 5.54 ± 1.55 mm and 1.48 ± 1.38 mm at baseline and at 12-month follow-up, respectively (p < 0.0001). This case series, with the limitations inherent in the study design, showed that the combination of NHA and PLGA, used as bone replacement graft in intrabony periodontal defects, may give significant improvements of periodontal parameters at 12-month follow-up.
Project description:Background. Statins are the recently evolved agents that aid in periodontal regeneration and ultimately in attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The current study was conducted to compare the effectiveness of 1.2% ATV and 1.2% SMV, in addition to scaling and root planing (SRP), in the treatment of intrabony defects in subjects with chronic periodontitis. Methods. Ninety-six individuals were categorized into three treatment groups: SRP plus 1.2% ATV, SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters of full-mouth plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Bone fill was assessed using percentage radiographic defect depth reduction at baseline, 6 months and 9 months. Results. Both ATV and SMV showed significant PD reduction and RAL gain than placebo. ATV group showed greater mean PD reduction and mean RAL gain as compared to SMV group at 3, 6 and 9 months. Furthermore, ATV group sites exhibited a significantly greater percentage of radiographic defect depth reduction (33.23 ± 3.11%; 34.84 ± 3.07%) as compared to SMV (30.39 ± 3.36%; 32.15 ± 3.37%) at 6 and 9 months. Conclusion. ATV resulted in greater improvements in clinical parameters with higher percentage of radiographic defect depth reduction as compared to SMV in the treatment of intrabony defects in CP subjects.
Project description:The primary outcome of the present study was to assess the percentage of pocket closure, and the secondary aim was to evaluate the clinical performance in terms of clinical attachment level (CAL) gain, probing pocket depth (PPD) reduction, and gingival recession (REC) after the use of cavitron ultrasonic surgical aspirator (CUSA) in deep infrabony defects. Fourteen deep infrabony defects in 11 patients who were previously treated with active periodontal therapy followed by one year of supportive periodontal therapy (at least three sessions) were additionally treated by the aid of CUSA. Eighty-six percent of the initial defects (12 out of 14) resulted in a PD < 5 mm, showing complete resolution six months after CUSA treatment, without any adverse event and with negligible pain (VAS from 0 to 3). CUSA showed potential as a method to promote pocket healing, reduce PPD, and increase clinical attachment (P < 0.001) in deep infrabony defects. This trial is registered with ClinicalTrials.gov NCT03567161.
Project description:To date, enamel matrix derivative (EMD) has been considered to be one of the few biomaterials for clinical use capable of demonstrating true periodontal regeneration. The aim of this two-center prospective clinical study was to evaluate 2-year outcome of periodontal regenerative therapy using EMD in the treatment of intrabony defects, performed as an 'advanced medical treatment' under the national healthcare system in Japan.Patients with chronic periodontitis who have completed initial periodontal therapy at either of the two dental school clinics were enrolled. Each contributed at least one intrabony defect of ?3 mm in depth. During surgery, EMD was applied to the defect following debridement. Twenty-two participants (mean age 55.2 years old, 9 men and 13 women) completed 2-year reevaluation, and a total of 42 defects were subjected to data analysis. Mean gains in clinical attachment level (CAL) at 1 and 2 years were 2.9 mm (38% of baseline CAL) and 3.1 mm (41%), respectively, both showing a significant improvement from baseline. There was also a significant reduction in probing depth (PD): mean reductions at 1 and 2 years were 3.2 and 3.3 mm, respectively. There was a progressive improvement in the mean percentages of bone fill from 26% at 1 year to 36% at 2 years. No significant difference in CAL gain at 2 years was found between 3-wall bone defects and other defect types combined. In multiple regression analysis, the baseline PD was significantly associated with CAL gain at 2 years. In this population of patients, the treatment of intrabony defects with EMD yielded clinically favorable outcomes, as assessed by periodontal and radiographical parameters, over a period of 2 years.
Project description:Combination of platelet-rich fibrin (PRF) and bone substitutes for the treatment of intrabony pockets is based on sound biologic rationale. The present study aimed to explore the clinical and radiographic effectiveness of autologous PRF and calcium phosphosilicate (CPS) putty alone and in combination in treatment of intrabony defects.A total of 45 intrabony defects were selected and randomly divided into three groups. In Group I, mucoperiosteal flap elevation followed by placement of PRF was done. In Group II, mucoperiosteal flap elevation followed by placement of CPS putty was done. In Group III, mucoperiosteal flap elevation followed by placement of PRF and CPS putty was done. Clinical parameters such as gingival index (GI), pocket depth (PD), clinical attachment level (CAL), gingival marginal position and radiographic parameters such as bone fill, changes in crestal bone level, and defect depth resolution were recorded at baseline and after 6 months postoperatively.Statistically significant changes in GI, PD reduction, CAL gain, defect fill, and defect depth resolution from baseline to 6 months were seen in all the three groups (P < 0.05). On intergroup comparison, no statistically significant changes were seen in all clinical parameters. However, the difference in defect fill and defect depth resolution between the Groups I and III and Group II and III was significant.Within limitations of study, combination of PRF and CPS putty showed a significant improvement in PD reduction, CAL gain, and bone fill.
Project description:BACKGROUND:Periodontitis, which progressively destroys tooth-supporting structures, is one of the most widespread infectious diseases and the leading cause of tooth loss in adults. Evidence from preclinical trials and small-scale pilot clinical studies indicates that stem cells derived from periodontal ligament tissues are a promising therapy for the regeneration of lost/damaged periodontal tissue. This study assessed the safety and feasibility of using autologous periodontal ligament stem cells (PDLSCs) as an adjuvant to grafting materials in guided tissue regeneration (GTR) to treat periodontal intrabony defects. Our data provide primary clinical evidence for the efficacy of cell transplantation in regenerative dentistry. METHODS:We conducted a single-center, randomized trial that used autologous PDLSCs in combination with bovine-derived bone mineral materials to treat periodontal intrabony defects. Enrolled patients were randomly assigned to either the Cell group (treatment with GTR and PDLSC sheets in combination with Bio-oss(®)) or the Control group (treatment with GTR and Bio-oss(®) without stem cells). During a 12-month follow-up study, we evaluated the frequency and extent of adverse events. For the assessment of treatment efficacy, the primary outcome was based on the magnitude of alveolar bone regeneration following the surgical procedure. RESULTS:A total of 30 periodontitis patients aged 18 to 65 years (48 testing teeth with periodontal intrabony defects) who satisfied our inclusion and exclusion criteria were enrolled in the study and randomly assigned to the Cell group or the Control group. A total of 21 teeth were treated in the Control group and 20 teeth were treated in the Cell group. All patients received surgery and a clinical evaluation. No clinical safety problems that could be attributed to the investigational PDLSCs were identified. Each group showed a significant increase in the alveolar bone height (decrease in the bone-defect depth) over time (p < 0.001). However, no statistically significant differences were detected between the Cell group and the Control group (p > 0.05). CONCLUSIONS:This study demonstrates that using autologous PDLSCs to treat periodontal intrabony defects is safe and does not produce significant adverse effects. The efficacy of cell-based periodontal therapy requires further validation by multicenter, randomized controlled studies with an increased sample size. TRIAL REGISTRATION:NCT01357785 Date registered: 18 May 2011.