NCT07414498

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

February 9, 2026

Last Update Submit

April 28, 2026

Conditions

PeriodontitisPeriimplantitis

Keywords

Subgingival MicrobiomePeriodontal SurgeryRegenerative SurgeryResective SurgeryPeri-Implantitis SurgeryNext-Generation Sequencing16S rRNA SequencingMicrobiome AnalysisSMDI

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Clinical attachment level (CAL) change

    Baseline and 12 weeks postoperatively

  • Probing depth (PD) change

    Baseline (preoperative) and 12 weeks postoperatively

  • Bleeding on probing

    Baseline (preoperative) and 12 weeks postoperatively

  • Implant pocket change

    Baseline (preoperative) and 12 weeks postoperatively

Study Arms (3)

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.

Procedure: Resective Periodontal Surgery

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.

Procedure: Regenerative Periodontal Surgery

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.

Procedure: Surgical Peri-implantitis Therapy

Interventions

Resective Periodontal SurgeryPROCEDURE

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.

Resective Periodontal Surgery
Regenerative Periodontal SurgeryPROCEDURE

Regenerative periodontal therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration.

Regenerative Periodontal Surgery
Surgical Peri-implantitis TherapyPROCEDURE

Surgical intervention for peri-implantitis including surgical access flap, defect debridement, implant surface decontamination, and resective or regenerative procedures as clinically indicated.

Peri-Implantitis Surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Münster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34428955BACKGROUND

  • 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.

    PMID: 31312781BACKGROUND

  • 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.

    PMID: 16272510BACKGROUND

Related Links

MeSH Terms

Conditions

PeriodontitisPeri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Benjamin Ehmke, Univ. Prof. Dr. med. dent.

    Clinic for Periodontology and Conservative Dentistry, University of Münster

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Ehmke, Univ. -Prof. Dr. med. dent.

CONTACT

+4902518347059ehmke@uni-muenster.de

Daniel Hagenfeld, PD Dr. med. dent.

CONTACT

+492518345092Daniel.hagenfeld@ukmuenster.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

February 23, 2026

Primary Completion

May 18, 2026

Study Completion

June 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)