MICRO-SURG: Subgingival Microbiome in Peri-Implantitis, Regenerative, and Resective Periodontal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital Muenster
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Resective Periodontal Surgery
Procedure/SurgeryApically 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
Procedure/SurgeryRegenerative periodontal therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration.
Surgical Peri-implantitis Therapy
Procedure/SurgerySurgical intervention for peri-implantitis including surgical access flap, defect debridement, implant surface decontamination, and resective or regenerative procedures as clinically indicated.
Treatment groups
84 Participants
are divided into 3 treatment groupsGroup A: Resective Periodontal SurgeryExperimental treatment 1 intervention
Group B: Regenerative Periodontal SurgeryExperimental treatment 1 intervention
Group C: Peri-Implantitis SurgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Subgingival Microbiome Composition After Periodontal and Peri-implant Surgery
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.
Time frame
Baseline (preoperative), intraoperative sampling (Day 0), 1 week, 4 weeks, and 12 weeks postoperativelySecondary outcomes
1
Clinical attachment level (CAL) change
Time frame
Baseline and 12 weeks postoperatively2
Probing depth (PD) change
Time frame
Baseline (preoperative) and 12 weeks postoperatively3
Bleeding on probing
Time frame
Baseline (preoperative) and 12 weeks postoperatively4
Implant pocket change
Time frame
Baseline (preoperative) and 12 weeks postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Muenster
Lead sponsor
dfg
Collaborator
Source ClinicalTrials.gov