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| Name | Class |
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| dfg | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resective Periodontal Surgery | Experimental | 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. |
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| Regenerative Periodontal Surgery | Experimental | 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. |
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| Peri-Implantitis Surgery | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resective Periodontal Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (preoperative), intraoperative sampling (Day 0), 1 week, 4 weeks, and 12 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level (CAL) change | Baseline and 12 weeks postoperatively | |
| Probing depth (PD) change | Baseline (preoperative) and 12 weeks postoperatively | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Ehmke, Univ. -Prof. Dr. med. dent. | Contact | +4902518347059 | ehmke@uni-muenster.de | |
| Daniel Hagenfeld, PD Dr. med. dent. | Contact | +492518345092 | Daniel.hagenfeld@ukmuenster.de |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Ehmke, Univ. Prof. Dr. med. dent. | Clinic for Periodontology and Conservative Dentistry, University of Münster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Münster | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34428955 | Background | Chen T, Marsh PD, Al-Hebshi NN. SMDI: An Index for Measuring Subgingival Microbial Dysbiosis. J Dent Res. 2022 Mar;101(3):331-338. doi: 10.1177/00220345211035775. Epub 2021 Aug 25. | |
| 31312781 | Background | Garcia ME, Bindman AB, Coffman J. Language-Concordant Primary Care Physicians for a Diverse Population: The View from California. Health Equity. 2019 Jul 1;3(1):343-349. doi: 10.1089/heq.2019.0035. eCollection 2019. |
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| Related Info | View source |
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Participants are assigned to one of three parallel surgical intervention groups: (i) resective periodontal surgery, (ii) regenerative periodontal surgery, or (iii) peri-implantitis surgery. No crossover between groups is planned.
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| Regenerative Periodontal Surgery | Procedure | Regenerative periodontal therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration. |
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| Surgical Peri-implantitis Therapy | Procedure | Surgical intervention for peri-implantitis including surgical access flap, defect debridement, implant surface decontamination, and resective or regenerative procedures as clinically indicated. |
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| Bleeding on probing |
| Baseline (preoperative) and 12 weeks postoperatively |
| Implant pocket change | Baseline (preoperative) and 12 weeks postoperatively |
| 16272510 | Background | Aas JA, Paster BJ, Stokes LN, Olsen I, Dewhirst FE. Defining the normal bacterial flora of the oral cavity. J Clin Microbiol. 2005 Nov;43(11):5721-32. doi: 10.1128/JCM.43.11.5721-5732.2005. |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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