scholarly journals Minimally-invasive Non-surgical Vs. Surgical Approach for Periodontal Intrabony Defects: a Randomised Controlled Trial

2019 ◽  
Author(s):  
Luigi Nibali ◽  
Vasiliki Koidou ◽  
Simona Salomone ◽  
Thomas Hamborg ◽  
R Allaker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Minimally Invasive ◽  
Surgical Therapy ◽  
Surgical Approach ◽  
Controlled Trial ◽  
Intrabony Defects ◽  
Defect Depth ◽  
Intrabony Defect ◽  
Patient Reported ◽  
Randomised Controlled

Abstract Background Periodontal intrabony defects are usually treated surgically with the aim to increase attachment and bone levels and reduce 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 ≥3mm. 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 loss (CAL) 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.

scholarly journals MINIMALLY-INVASIVE NON-SURGICAL VS. SURGICAL APPROACH FOR PERIODONTAL INTRABONY DEFECTS: A RANDOMISED CONTROLLED TRIAL

2019 ◽  
Author(s):  
Luigi Nibali ◽  
Vasiliki Koidou ◽  
Simona Salomone ◽  
Thomas Hamborg ◽  
R Allaker ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Minimally Invasive ◽  
Surgical Therapy ◽  
Surgical Approach ◽  
Controlled Trial ◽  
Intrabony Defects ◽  
Defect Depth ◽  
Intrabony Defect ◽  
Patient Reported ◽  
Randomised Controlled

Abstract Background: Periodontal intrabony defects are usually treated surgically with the aim to increase attachment and bone levels and reduce 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 ≥3mm. 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 loss (CAL) 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: This study was registered on clinicaltrials.gov NCT03797807 (date registered: 9 January 2019). Keywords: Periodontitis, intrabony defect, minimally-invasive, quality of life, bone

scholarly journals Modified minimally invasive surgical technique plus Bio-Oss Collagen for regenerative therapy of isolated interdental intrabony defects: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040046
Author(s):  
Churen Zhang ◽  
Haidong Zhang ◽  
Zhaoguo Yue ◽  
Lili Miao ◽  
Ye Han ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Surgical Technique ◽  
Minimally Invasive ◽  
Controlled Trial ◽  
Periodontal Regeneration ◽  
Intrabony Defects ◽  
Regenerative Effect ◽  
Minimally Invasive Surgical ◽  
Human Cancellous Bone ◽  
Randomised Controlled

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 group: M-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.

scholarly journals Protocol for a randomised controlled trial to compare postoperative complications between minimally invasive and open DIStal PAnCreaTectomy (DISPACT-2 trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e047867
Author(s):  
Pascal Probst ◽  
Fabian Schuh ◽  
Colette Dörr-Harim ◽  
Anja Sander ◽  
Thomas Bruckner ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Minimally Invasive ◽  
Distal Pancreatectomy ◽  
Controlled Trial ◽  
Postoperative Mortality ◽  
Morbidity Rate ◽  
Distal Pancreatic Resection ◽  
Open Distal Pancreatectomy ◽  
Patient Reported ◽  
Randomised Controlled

IntroductionIn recent years, minimally invasive distal pancreatectomy (MIDP) has been used with increasing frequency to accelerate patient recovery. Distal pancreatectomy has an overall morbidity rate of 30%–40%. The known advantages of minimally invasive techniques must be rigorously compared with those of open surgery before they can be completely implemented into clinical practice.Methods and analysisDISPACT-2 is a multicentre randomised controlled trial comparing minimally invasive (conventional laparoscopic or robotic assisted) with open distal pancreatic resection in patients undergoing elective surgery for benign as well as malign diseases of the pancreatic body and tail. After screening for eligibility and obtaining informed consent, a total of 294 adult patients will be preoperatively randomised in a 1:1 ratio. The primary hypothesis is that MIDP is non-inferior to open distal pancreatectomy in terms of postoperative mortality and morbidity expressed as the Comprehensive Complication Index (CCI) within 3 months after index operation, with a non-inferiority margin of 7.5 CCI points. Secondary endpoints include pancreas-specific complications, oncological safety and patient reported outcomes. Follow-up for each individual patient will be 2 years.Ethics and disseminationThe DISPACT-2 trial has been approved by the Ethics Committee of the medical faculty of Heidelberg University (S-693/2017). Results of the primary endpoint will be available in 2024 and will be published at national and international meetings. Full results will be made available in an open access, peer-reviewed journal. The website www.dispact.de contains up-to-date information regarding the trial.Trial registration numberDRKS00014011

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