MICRO-SURG: Subgingival Microbiome in Peri-Implantitis, Regenerative, and Resective Periodontal Surgery

Официальное название

MICRO-SURG: Investigation of Subgingival Microbiome Changes Following Surgical Peri-Implantitis Therapy, Regenerative Periodontal Surgery, and Resective Periodontal Surgery Using Next-Generation Sequencing

Обзор

This clinical study investigates how the subgingival microbiome changes after three different periodontal and peri-implant surgical procedures: (1) resective periodontal surgery, (2) regenerative periodontal surgery, and (3) peri-implantitis surgery. The aim is to characterize microbial shifts associated with these commonly used surgical treatments and to determine whether the type of surgery influences the recovery or disruption of the subgingival ecosystem. Adult patients with periodontitis or peri-implantitis will receive the procedure indicated for their condition. Subgingival plaque samples will be collected at baseline and at defined postoperative follow-up intervals. Microbiome analysis will be performed using next-generation sequencing (NGS), and microbial changes will be evaluated with the Subgingival Microbial Dysbiosis Index (SMDI). Insights from this study may help improve prevention, diagnostics, and treatment strategies for periodontal and peri-implant diseases.

Вмешательства

• Процедура Resective Periodontal Surgery
  Apically repositioned full-thickness mucoperiosteal flap with resective surgical treatment of periodontal defects. Includes removal of inflamed tissue and recontouring of osseous structures according to clinical indication. Microbiome samples are taken pre-, intra- and postoperatively.
• Процедура Regenerative Periodontal Surgery
  Regenerative periodontal therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration.
• Процедура Surgical Peri-implantitis Therapy
  Surgical intervention for peri-implantitis including surgical access flap, defect debridement, implant surface decontamination, and resective or regenerative procedures as clinically indicated.

Первичные конечные точки

• Change in Subgingival Microbiome Composition After Periodontal and Peri-implant Surgery [Срок оценки: Baseline (preoperative), intraoperative sampling (Day 0), 1 week, 4 weeks, and 12 weeks postoperatively]

Вторичные конечные точки (4)

• Clinical attachment level (CAL) change [Срок оценки: Baseline and 12 weeks postoperatively]
• Probing depth (PD) change [Срок оценки: Baseline (preoperative) and 12 weeks postoperatively]
• Bleeding on probing [Срок оценки: Baseline (preoperative) and 12 weeks postoperatively]
• Implant pocket change [Срок оценки: Baseline (preoperative) and 12 weeks postoperatively]

Критерии участия

Критерии включения

• Age 18 years or older
• Confirmed diagnosis of Peri-implantitis (for the peri-implantitis surgery arm), or Stage III/IV periodontitis (for the periodontal surgery arms)
• Indication for surgical therapy corresponding to the assigned study arm
• Ability to understand the study procedures and provide written informed consent
• Adequate oral hygiene (API/SBI according to the clinician's judgment)
• Willingness and ability to attend all follow-up visits
• Willingness to provide salivary and subgingival plaque samples for microbiome analyses (NGS, SMDI)

Критерии исключения

• Systemic conditions contraindicating oral surgical procedures
• Severe systemic diseases (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders)
• Use of systemic antibiotics within the previous 3 months
• Active COVID-19 infection at the time of surgery
• Pregnancy or breastfeeding
• Drug or alcohol abuse
• Smoking more than 10 cigarettes per day
• Known allergies to materials used in the assigned intervention (e.g., local anesthetics, sutures, membranes, bone grafting materials)
• Participation in another clinical study within the previous 30 days
• Acute oral infections that contraindicate participation
• Inability or unwillingness to comply with all follow-up appointments Lack of capacity to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University Hospital Münster — Münster

Публикации

• Chen T, Marsh PD, Al-Hebshi NN. SMDI: An Index for Measuring Subgingival Microbial Dysbiosis. J Dent Res. 2022 Mar;101(3):331-338. doi: 10.1177/00220345211035775. Epub 2021 Aug 25. PMID 34428955
• Garcia ME, Bindman AB, Coffman J. Language-Concordant Primary Care Physicians for a Diverse Population: The View from California. Health Equity. 2019 Jul 1;3(1):343-349. doi: 10.1089/heq.2019.0035. eCollection 2019. PMID 31312781
• Aas JA, Paster BJ, Stokes LN, Olsen I, Dewhirst FE. Defining the normal bacterial flora of the oral cavity. J Clin Microbiol. 2005 Nov;43(11):5721-32. doi: 10.1128/JCM.43.11.5721-5732.2005. PMID 16272510

Идентификаторы

NCT: NCT07414498 · MICRO-SURG-UKM-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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