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.
Regenerative Periodontal Surgery: Regenerative periodontal therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration.
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Primary outcome measure(s)
Change in Subgingival Microbiome Composition After Periodontal and Peri-implant Surgery — Baseline (preoperative), intraoperative sampling (Day 0), 1 week, 4 weeks, and 12 weeks postoperatively Assessment of changes in the subgingival and peri-implant microbiome before, during, and after surgical treatment.
Microbiome samples are collected at standardized time points and analyzed using next-generation sequencing (NGS), including 16S rRNA gene sequencing and Structure Microbial Diversity Index (SMDI).
The primary outcome reflects quantitative and qualitative microbial shifts induced by resective periodontal surgery, regenerative periodontal surgery, or peri-implantitis surgery.
Trial sites (1)
Facility
City
Region
Status
University Hospital Münster
Münster
North Rhine-Westphalia
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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