Periodontitis, Periimplantitis
Conditions
Keywords
Subgingival Microbiome, Periodontal Surgery, Regenerative Surgery, Resective Surgery, Peri-Implantitis Surgery, Next-Generation Sequencing, 16S rRNA Sequencing, Microbiome Analysis, SMDI
Brief 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.
Interventions
PROCEDUREResective Periodontal Surgery
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.
PROCEDURERegenerative Periodontal Surgery
Regenerative periodontal therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration.
PROCEDURESurgical Peri-implantitis Therapy
Surgical intervention for peri-implantitis including surgical access flap, defect debridement, implant surface decontamination, and resective or regenerative procedures as clinically indicated.
Sponsors
University Hospital Muenster
dfg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subgingival Microbiome Composition After Periodontal and Peri-implant Surgery | Baseline (preoperative), intraoperative sampling (Day 0), 1 week, 4 weeks, and 12 weeks postoperatively | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Clinical attachment level (CAL) gain | Baseline and 12 weeks postoperatively |
| Probing depth (PD) reduction | Baseline (preoperative) and 12 weeks postoperatively |
| Bleeding on probing | Baseline (preoperative) and 12 weeks postoperatively |
| Implant pocket reduction | Baseline (preoperative) and 12 weeks postoperatively |
Countries
Germany
Contacts
CONTACTBenjamin Ehmke, Univ. -Prof. Dr. med. dent.
CONTACTDaniel Hagenfeld, PD Dr. med. dent.
PRINCIPAL_INVESTIGATORBenjamin Ehmke, Univ. Prof. Dr. med. dent.
Clinic for Periodontology and Conservative Dentistry, University of Münster
Outcome results
None listed