PeriodontitisMICROSURGNCT07414498
MICRO-SURG: Subgingival Microbiome in Peri-Implantitis, Regenerative, and Resective Periodontal Surgery
A study testing Resective Periodontal Surgery, Regenerative Periodontal Surgery and Surgical Peri-implantitis Therapy in people with Periodontitis and Periimplantitis, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontitis, Periimplantitis
- What is being tested?
- Resective Periodontal Surgery, Regenerative Periodontal Surgery and Surgical Peri-implantitis Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 23 Feb 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Münster
Münster, North Rhine-Westphalia, 48149
Benjamin Ehmke, Univ.-Prof. Dr. med. dent., +4902518347059, ehmke@uni-muenster.de
Maher Heno, +492518345092, Maher.heno@ukmuenster.de
About this study
Official title: MICRO-SURG: Investigation of Subgingival Microbiome Changes Following Surgical Peri-Implantitis Therapy, Regenerative Periodontal Surgery, and Resective Periodontal Surgery Using Next-Generation Sequencing
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.
- Conditions
- Periodontitis, Periimplantitis
- Being tested
- Resective Periodontal Surgery, Regenerative Periodontal Surgery, Surgical Peri-implantitis Therapy
- Keywords
- Subgingival Microbiome, Periodontal Surgery, Regenerative Surgery, Resective Surgery, Peri-Implantitis Surgery, Next-Generation Sequencing, 16S rRNA Sequencing, Microbiome Analysis, SMDI
- Medical subject headings
- Periodontitis, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resective Periodontal SurgeryProcedure or 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.
Regenerative Periodontal SurgeryProcedure or surgery
Regenerative periodontal therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration.
Surgical Peri-implantitis TherapyProcedure or surgery
Surgical intervention for peri-implantitis including surgical access flap, defect debridement, implant surface decontamination, and resective or regenerative procedures as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Surgical Peri-implantitis Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (preoperative), intraoperative sampling (Day 0), 1 week, 4 weeks, and 12 weeks postoperatively
Secondary outcomes (4)
Clinical attachment level (CAL) change
Measured: Baseline and 12 weeks postoperatively
Probing depth (PD) change
Measured: Baseline (preoperative) and 12 weeks postoperatively
Bleeding on probing
Measured: Baseline (preoperative) and 12 weeks postoperatively
Implant pocket change
Measured: Baseline (preoperative) and 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start23 Feb 2026
- Primary completion18 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- dfg
- Responsible party
- Sponsor
- Investigators
- Benjamin Ehmke, Univ. Prof. Dr. med. dent., Principal investigator, Clinic for Periodontology and Conservative Dentistry, University of Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414498
- Sponsor's protocol ID
- MICRO-SURG-UKM-2025
- Acronym
- MICROSURG
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34428955Garcia 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.
PubMed 31312781Aas 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.
PubMed 16272510
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICRO-SURG: Investigation of Subgingival Microbiome Changes Following Surgical Peri-Implantitis Therapy, Regenerative Periodontal Surgery, and Resective Periodontal Surgery Using Next-Generation Sequencing
- ClinicalTrials.gov ID
- NCT07414498
- Acronym / sponsor ID
- MICROSURG / MICRO-SURG-UKM-2025
- Conditions
- Periodontitis, Periimplantitis
- Keywords
- Subgingival Microbiome, Periodontal Surgery, Regenerative Surgery, Resective Surgery, Peri-Implantitis Surgery, Next-Generation Sequencing, 16S rRNA Sequencing, Microbiome Analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- dfg
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 18 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Resective Periodontal Surgery | Experimental | Procedure: Resective Periodontal SurgeryParticipants 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. |
| Regenerative Periodontal Surgery | Experimental | Procedure: Regenerative Periodontal SurgeryParticipants 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. |
| Peri-Implantitis Surgery | Experimental | Procedure: Surgical Peri-implantitis TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resective Periodontal SurgeryApically 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. | Procedure or surgery | Resective Periodontal Surgery |
| Regenerative Periodontal SurgeryRegenerative periodontal therapy including the use of autogenous bone, membranes, and/or bone substitute materials for periodontal regeneration. | Procedure or surgery | Regenerative Periodontal Surgery |
| Surgical Peri-implantitis TherapySurgical intervention for peri-implantitis including surgical access flap, defect debridement, implant surface decontamination, and resective or regenerative procedures as clinically indicated. | Procedure or surgery | Peri-Implantitis Surgery |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 34428955Chen 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.
- Background: PubMed 31312781Garcia 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.
- Background: PubMed 16272510Aas 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Ehmke, Univ. Prof. Dr. med. dent. principal investigator
Clinic for Periodontology and Conservative Dentistry, University of Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resective Periodontal Surgery, Regenerative Periodontal Surgery and Surgical Peri-implantitis Therapy in people with Periodontitis and Periimplantitis, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Ehmke, Univ. -Prof. Dr. med. dent. (+4902518347059, ehmke@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07414498, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.