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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.

SUBMITTER: Nibali L

PROVIDER: S-EPMC6660941 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial.

Nibali L L Koidou V V Salomone S S Hamborg T T Allaker R R Ezra R R Zou L L Tsakos G G Gkranias N N Donos N N

Trials 20190727 1

<h4>Background</h4>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 the ...[more]

PMID: 31351492

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Project description:IntroductionPeriodontal regeneration surgery has been widely used to deal with intrabony defects. Modified minimally invasive surgical technique (M-MIST) is designed to deal with isolated interdental intrabony defects, and has achieved satisfactory periodontal regenerative effect. Bio-Oss Collagen, as a bioactive material, has been applied for periodontal regeneration. It is similar to human cancellous bone, with the ability to promote bone formation; furthermore, it has exceptional plasticity and spatial stability. The combination of different materials and techniques has become a research hotspot in recent years. By combining the superiority of regeneration technology and materials, better regenerative effect can be achieved. This study will search for differences between M-MIST combined with Bio-Oss Collagen, and M-MIST alone in regeneration therapy for intrabony defects.Methods and analysisThe present research is designed as a two-group parallel randomised controlled trial. The total number of patients is 40. The patients will be randomly assigned to two groups, with 20 participants in each group, for further periodontal regenerative surgery. Test group: M-MIST plus Bio-Oss Collagen.Control groupM-MIST. After 12 months, the measurement indices will be recorded; these will include clinical attachment gain and radiographical intrabony defect depth change as the primary results, and secondary outcomes of full-mouth plaque scores, probing depth, full-mouth bleeding scores, gingival recession, mobility, gingival papilla height and Visual Analogue Scale. The paired samples t-test will be applied to detect any difference between baseline and 1-year registrations. A general linear model will be performed to study the relationship between the secondary and the primary outcome.Ethics and disseminationThe present research has received approval from the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-202053002). Data of the present research will be registered with the International Clinical Trials Registry Platform. Additionally, we will disseminate the results through scientific dental journals.Trial registration numberChiCTR-2000030851.Protocol versionProtocol Version 4, 14 July 2020.

Project description:BackgroundIn the regenerative treatment of intrabony periodontal defects, surgical strategies are primarily determined by defect morphologies. In certain cases, however, direct clinical measurements and intraoral radiographs do not provide sufficient information on defect morphologies. Therefore, the application of cone-beam computed tomography (CBCT) has been proposed in specific cases. 3D virtual models reconstructed with automatic thresholding algorithms have already been used for diagnostic purposes. The aim of this study was to utilize 3D virtual models, generated with a semi-automatic segmentation method, for the treatment planning of minimally invasive periodontal surgeries and to evaluate the accuracy of the virtual models, by comparing digital measurements to direct intrasurgical measurements.MethodsFour patients with a total of six intrabony periodontal defects were enrolled in the present study. Two months following initial periodontal treatment, a CBCT scan was taken. The novel semi-automatic segmentation method was performed in an open-source medical image processing software (3D Slicer) to acquire virtual 3D models of alveolar and dental structures. Intrasurgical and digital measurements were taken, and results were compared to validate the accuracy of the digital models. Defect characteristics were determined prior to surgery with conventional diagnostic methods and 3D virtual models. Diagnostic assessments were compared to the actual defect morphology during surgery.ResultsDifferences between intrasurgical and digital measurements in depth and width of intrabony components of periodontal defects averaged 0.31 ± 0.21 mm and 0.41 ± 0.44 mm, respectively. In five out of six cases, defect characteristics could not be assessed precisely with direct clinical measurements and intraoral radiographs. 3D models generated with the presented semi-automatic segmentation method depicted the defect characteristics correctly in all six cases.ConclusionIt can be concluded that 3D virtual models acquired with the described semi-automatic segmentation method provide accurate information on intrabony periodontal defect morphologies, thus influencing the treatment strategy. Within the limitations of this study, models were found to be accurate; however, further investigation with a standardized validation process on a large number of participants has to be conducted.

Project description:ObjectivesMinimally invasive flap designs have been introduced to enhance blood clot stability and support wound healing. Limited data appear to suggest, that in intrabony defects, better clinical outcomes can be achieved by means of minimally invasive flap compared to more extended flaps. The aim of this study was to evaluate the healing of intrabony defects treated with either minimally invasive surgical flaps or with modified or simplified papilla preservation techniques in conjunction with the application of an enamel matrix derivative (EMD).Materials and methodsForty-seven subjects were randomly assigned to either test (N = 23) or control (N = 24) procedures. In the test group, the intrabony defects were accessed by means of either minimally invasive surgical technique (MIST) or modified minimally invasive surgical technique (M-MIST) according to the defect localization while the defects in the control group were treated with either the modified or simplified papilla preservation (MPP) or the simplified papilla preservation technique (SPP). EMD was used as regenerative material in all defects. The following clinical parameters were recorded at baseline and after 12 months: full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depths (PD), clinical attachment level (CAL), and gingival recession (GR). Early healing index (EHI) score was assessed in both groups 1 week following the surgery. CAL gain was set as primary outcome.ResultsAfter 12 months follow-up, the CAL gain was 4.09 ± 1.68 mm in test group and 3.79 ± 1.67 mm in control group, while the PD reduction was 4.52 ± 1.34 mm and 4.04 ± 1.62 mm for test and control sites. In both groups, a minimal GR increase (0.35 ± 1.11 mm and 0.25 ± 1.03 mm) was noted. No residual PDs ≥ 6 mm were recorded in both groups. CAL gains of 4-5 mm were achieved in 30.4% and in 29.2% of test and control group, respectively. Moreover, CAL gains ≥ 6 mm were recorded in 21.7% of experimental sites and in 20.8% of control sites. No statistically significant differences in any of the evaluated parameters were found between the test and control procedures (P > 0.05). After 1 week post-surgery, a statistically significant difference (P < 0.05) between the groups was found in terms of EHI score.ConclusionsWithin the limits of this pilot RCT, the results have failed to show any differences in the measured parameters following treatment of intrabony defects with EMD, irrespective of the employed surgical technique.Clinical relevanceIn intrabony defects, the application of EMD in conjunction with either MIST/M-MIST or M-PPT/SPPT resulted in substantial clinical improvements.

Project description:BackgroundPeriodontitis, 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.MethodsWe 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.ResultsA 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).ConclusionsThis 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 registrationNCT01357785 Date registered: 18 May 2011.

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Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial.

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Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial.

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