An interventional study of Resective Periodontal Surgery and Regenerative Periodontal Surgery in Periodontitis and Periimplantitis, sponsored by University Hospital Muenster. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University Hospital Muenster · Not applicable, Interventional, and Treatment
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 84 is above the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm undergo subgingival microbiome sampling in the context of resective periodontal surgery. Microbiome samples are collected at standardized time points (preoperative baseline, intraoperative sampling, and postoperative follow-ups). Samples are analyzed using next-generation sequencing (NGS), including 16S rRNA profiling, and Structure-Microbial Diversity Index (SMDI) evaluation. The goal is to characterize microbial shifts associated with resective periodontal therapy.
Procedure: Resective Periodontal Surgery
Participants undergoing regenerative periodontal therapy are enrolled for longitudinal subgingival microbiome analysis. Microbiome samples are obtained at predefined time points (baseline, intraoperative, postoperative). Sequencing is performed using next-generation sequencing (NGS) and 16S rRNA analysis, with SMDI calculations to assess microbial diversity changes associated with regenerative procedures.
Procedure: Regenerative Periodontal Surgery
Participants in this arm receive systematic peri-implant microbiome profiling before, during, and after peri-implantitis surgery. Sampling includes submucosal/peri-implant biofilm collection at standardized visits. Analyses include next-generation sequencing (NGS), 16S rRNA sequencing, and SMDI-based microbial diversity assessment to evaluate microbial changes associated with peri-implantitis therapy.
Procedure: Surgical Peri-implantitis Therapy
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 therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration.
Surgical intervention for peri-implantitis including surgical access flap, defect debridement, implant surface decontamination, and resective or regenerative procedures as clinically indicated.
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 postoperatively
Clinical attachment level (CAL) change
Time frame: Baseline and 12 weeks postoperatively
Probing depth (PD) change
Time frame: Baseline (preoperative) and 12 weeks postoperatively
Bleeding on probing
Time frame: Baseline (preoperative) and 12 weeks postoperatively
Implant pocket change
Time frame: Baseline (preoperative) and 12 weeks postoperatively
Plan to share: No
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