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NCT Number: NCT07414498

MICRO-SURG: Subgingival Microbiome in Peri-Implantitis, Regenerative, and Resective Periodontal Surgery

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.

Recruiting

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Key information

Conditions

Periodontitis Mouth Diseases Peri-Implantitis Periimplantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Regenerative Periodontal Surgery

Procedure

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

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.

Primary outcomes

  1. Change in Subgingival Microbiome Composition After Periodontal and Peri-implant Surgery

    Time frame: 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 outcomes

  1. Clinical attachment level (CAL) change

    Time frame: Baseline and 12 weeks postoperatively

  2. Probing depth (PD) change

    Time frame: Baseline (preoperative) and 12 weeks postoperatively

  3. Bleeding on probing

    Time frame: Baseline (preoperative) and 12 weeks postoperatively

  4. Implant pocket change

    Time frame: Baseline (preoperative) and 12 weeks postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+4902518347059

Daniel Hagenfeld, PD Dr. med. dent.

CONTACT

[email protected]

+492518345092

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • dfg

Registry information

Official study title

MICRO-SURG: Investigation of Subgingival Microbiome Changes Following Surgical Peri-Implantitis Therapy, Regenerative Periodontal Surgery, and Resective Periodontal Surgery Using Next-Generation Sequencing

Acronym: MICROSURG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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