MICRO-SURG: Subgingival Microbiome in Peri-Implantitis, Regenerative, and Resective Periodontal S… (NCT07414498) | Clinical Trial Compass
RecruitingNot Applicable
MICRO-SURG: Subgingival Microbiome in Peri-Implantitis, Regenerative, and Resective Periodontal Surgery
Germany84 participantsStarted 2026-02-23
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Subgingival Microbiome Composition After Periodontal and Peri-implant Surgery