How bacteria beneath the gums change after resective, regenerative, or peri-implant surgery
MICRO-SURG: Investigation of Subgingival Microbiome Changes Following Surgical Peri-Implantitis Therapy, Regenerative Periodontal Surgery, and Resective Periodontal Surgery Using Next-Generation Sequencing
NA · University Hospital Muenster · NCT07414498
We will test whether three types of gum and implant surgery cause different changes in the bacteria beneath the gums in adults with periodontitis or peri-implantitis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital Muenster (other) |
| Locations | 1 site (Münster, North Rhine-Westphalia) |
| Trial ID | NCT07414498 on ClinicalTrials.gov |
What this trial studies
Adults with periodontitis or peri-implantitis will receive the surgical treatment indicated for their condition (resective periodontal, regenerative periodontal, or peri-implantitis surgery). Subgingival plaque and saliva samples will be collected at baseline and at defined postoperative follow-ups. Microbiome composition will be analyzed using next-generation sequencing and summarized with the Subgingival Microbial Dysbiosis Index (SMDI). The study aims to characterize microbial shifts after each procedure and determine whether surgical type influences recovery or disruption of the subgingival ecosystem.
Who should consider this trial
Good fit: Adults with Stage III/IV periodontitis who require resective or regenerative surgery, or adults with peri-implantitis who require surgical therapy, who can consent, maintain adequate oral hygiene, attend follow-up visits, and provide plaque and saliva samples.
Not a fit: Patients with uncontrolled systemic disease, recent antibiotic use, active infection, heavy smoking, pregnancy, or those who do not require surgical therapy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help tailor surgical choices and post-operative care to protect or restore a healthier subgingival microbiome and reduce disease recurrence.
How similar studies have performed: Previous NGS-based studies have shown that periodontal treatments alter the subgingival microbiome, but direct comparisons of different surgical procedures are relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Münster, North Rhine-Westphalia
- University Hospital Münster — Münster, North Rhine-Westphalia, Germany (RECRUITING)
Study contacts
- Principal investigator: Benjamin Ehmke, Univ. Prof. Dr. med. dent. — Clinic for Periodontology and Conservative Dentistry, University of Münster
- Study coordinator: Benjamin Ehmke, Univ. -Prof. Dr. med. dent.
- Email: ehmke@uni-muenster.de
- Phone: +4902518347059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periodontitis, Periimplantitis, Subgingival Microbiome, Periodontal Surgery, Regenerative Surgery, Resective Surgery, Peri-Implantitis Surgery, Next-Generation Sequencing