Peri-ImplantitisNCT06153212
Regenerative Treatment of Peri-implantitis
A study testing Membrane placement with bone grafting in people with Peri-Implantitis, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Membrane placement with bone grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 1 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
- Subjects having at least one dental implant with peri-implantitis according to the definition proposed by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018):
- Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
- Correct 3-dimensional implant positioning, or buccal position ≤ 1 mm
- Implants which have been in function for at least 6 months
Who cannot join
- A clearly mal-positioned dental implant
- Significant interproximal horizontal bone loss (more than 50% of implant fixture length)
- A mobile dental implant
- Presence of uncontrolled or untreated periodontal disease
- More than 2 weeks usage of antibiotics in the past two months
- Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c > 8)).
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- Pregnant subjects or individuals attempting to get pregnant (self-reported)
- Subjects smoking more than 10 cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
- Subjects unable to maintain adequate oral hygiene (O'Leary plaque index more than 50%) (O'Leary et al., 1972)
- Any other contraindications for undergoing periodontal surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: Regenerative Treatment of Peri-implantitis: A Comparison of the Reinforced PTFE Mesh (RPM) and the Collagen Membrane in the Submerged Approach: a Randomized Controlled Clinical Trial
The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.
Read the detailed description
Peri-implantitis is an inflammatory response that leads to irreversible loss of implant supporting bone. This study will investigate the regenerative outcomes obtained with two membranes for surgical reconstructive treatment of peri-implantitis defects when the implant is submerged and primary wound closure is obtained. In one group the newly designed d-PTFE membrane with macropores, known as the RPM membrane will be utilized, which will be compared to the traditional collagen membrane used in the other group. The clinical, radiographic, and histologic outcomes for the regenerative treatment of peri-implantitis when utilizing the same bone graft in combination with either a collagen membrane or the RPM will be evaluated via a parallel-arm randomized controlled clinical trial.
32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.
- Conditions
- Peri-Implantitis
- Being tested
- Membrane placement with bone grafting
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Membrane placement with bone graftingProcedure or surgery
The diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane.
| Study group | Role | What they receive |
|---|---|---|
| PTFE Mesh Membrane | Experimental | A reinforced PTFE Mesh membrane will be used to cover the bone graft. Receives: Procedure: Membrane placement with bone grafting |
| Collagen membrane | Active comparator | A collagen membrane will be used to cover the bone graft. Receives: Procedure: Membrane placement with bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth measurements in millimeters
To compare probing depth measurements using a periodontal probe after peri-implantitis treatment
Measured: About 5 weeks before baseline surgery and at 8.5 months after baseline surgery.
Bone measurements in millimeters
Bone measurements obtained from CBCT
Measured: Baseline and 8 months after baseline surgery
Secondary outcomes (3)
Clinical attachment levels in millimeters
To compare clinical attachment measurements using a periodontal probe from baseline to the final follow-up visit
Measured: 8 months after baseline surgery
Marginal bone levels in millimeters at the implant site
To compare marginal bone measurements from periapical radiographs
Measured: 8 months after baseline surgery
Volumetric changes of grafted area in cubic millimeters
To compare volumetric bone measurements of the grafted areas from CBCT
Measured: 8 months after baseline surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start2 Nov 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Osteogenics Biomedical
- Responsible party
- Principal investigator, Muhammad Saleh, University of Michigan
- Investigators
- Muhammad Saleh, BDS, MSD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153212
- Sponsor's protocol ID
- HUM00169735
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2023
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Treatment of Peri-implantitis: A Comparison of the Reinforced PTFE Mesh (RPM) and the Collagen Membrane in the Submerged Approach: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06153212
- Acronym / sponsor ID
- HUM00169735
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Osteogenics Biomedical
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 Dec 2023 (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.
The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.
Detailed description
Peri-implantitis is an inflammatory response that leads to irreversible loss of implant supporting bone. This study will investigate the regenerative outcomes obtained with two membranes for surgical reconstructive treatment of peri-implantitis defects when the implant is submerged and primary wound closure is obtained. In one group the newly designed d-PTFE membrane with macropores, known as the RPM membrane will be utilized, which will be compared to the traditional collagen membrane used in the other group. The clinical, radiographic, and histologic outcomes for the regenerative treatment of peri-implantitis when utilizing the same bone graft in combination with either a collagen membrane or the RPM will be evaluated via a parallel-arm randomized controlled clinical trial.
32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTFE Mesh Membrane | Experimental | Procedure: Membrane placement with bone graftingA reinforced PTFE Mesh membrane will be used to cover the bone graft. |
| Collagen membrane | Active comparator | Procedure: Membrane placement with bone graftingA collagen membrane will be used to cover the bone graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
- Subjects having at least one dental implant with peri-implantitis according to the definition proposed by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018):
- Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
- Correct 3-dimensional implant positioning, or buccal position ≤ 1 mm
Key exclusion criteria (10 listed)
- A clearly mal-positioned dental implant
- Significant interproximal horizontal bone loss (more than 50% of implant fixture length)
- A mobile dental implant
- Presence of uncontrolled or untreated periodontal disease
- More than 2 weeks usage of antibiotics in the past two months
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 |
|---|---|---|
| Membrane placement with bone graftingThe diseased dental implant will be cleaned and the bone defect will be filled with bone graft and covered by a membrane. | Procedure or surgery | Collagen membrane, PTFE Mesh Membrane |
Primary outcome
Probing depth measurements in millimeters
Time frame: About 5 weeks before baseline surgery and at 8.5 months after baseline surgery.
To compare probing depth measurements using a periodontal probe after peri-implantitis treatment
Bone measurements in millimeters
Time frame: Baseline and 8 months after baseline surgery
Bone measurements obtained from CBCT
3 secondary outcomes
Clinical attachment levels in millimeters
Time frame: 8 months after baseline surgery
Marginal bone levels in millimeters at the implant site
Time frame: 8 months after baseline surgery
Volumetric changes of grafted area in cubic millimeters
Time frame: 8 months after baseline surgery
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 1 Sep 2026.
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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.
Muhammad Saleh, BDS, MSD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Membrane placement with bone grafting in people with Peri-Implantitis, run by University of Michigan at 1 site in United States.
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 6 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 1 Sep 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth measurements in millimeters (time frame: About 5 weeks before baseline surgery and at 8.5 months after baseline surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.