An interventional study of Resective surgery with implantoplasty and Resective surgery with mechanical debridement in Peri-implantitis, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
Among 32 studies in Peri-Implantitis with a site in United States — 7 open to participants now, 9 under way, none of them phase 3. Peri-Implantitis · United States.
Among the 32 studies in Peri-Implantitis with a site in United States, this one is the 10th largest by planned enrollment of the 22 interventional ones, is one of 2 that started in 2026, is one of 15 with no phase, and was the 32nd registered.
322 studies on the registry are indexed under Peri-Implantitis; 88 are open to participants now.
This study's planned enrollment of 44 is close to the median of 40 across 195 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →7 of the 32 studies in Peri-Implantitis with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 48 Peri-Implantitis studies recruiting now, 26 (54%) set no upper age limit and 9 (19%) stop at 75 or younger; 7 take children under 18; 25 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2026.
Median enrollment 42 across the 22 interventional studies, 40 across the 10 observational. Of the 21 that completed or were terminated, 7 (33%) have results posted.
6 of 32 have an industry lead sponsor. The 10 most frequent:
University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
University of Pittsburgh has 4 studies filed under Peri-Implantitis — fewer than ten, so there is no comparison to draw.
5 of the studies in Peri-Implantitis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07325747University of MichiganImmediate Versus Delayed Surgical Reconstruction of Peri-implantitis Intra-bony Defects. | 2027-02 |
| NCT06063876University of PittsburghExperimental Peri-implant Mucositis on Implant Sites That Were Previously Treated With or Without Implantoplasty | 2027-04 |
| NCT06153212University of MichiganRegenerative Treatment of Peri-implantitis | 2027-06-01 |
| NCT06430268Andrea RavidaEfficacy of Non-surgical and Surgical Surface Decontamination Methods on Peri-implantitis-affected Implants | 2027-06-30 |
| NCT07550127University of PittsburghPeri-implantitis Management: Surgical and Maintenance Outcomes | 2027-06-30 |
Among the 32 studies in Peri-Implantitis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
The goal of this clinical trial is to learn how two standard surgical treatments for peri-implantitis affect inflammation around dental implants. Participants will be randomly assigned to receive resective surgery with implantoplasty or resective surgery with mechanical debridement only. Participants will provide blood samples before surgery, about 48 hours after surgery, and about 2 weeks after surgery. Participants will also provide saliva samples before surgery and about 2 weeks after surgery, and small gum tissue samples at baseline and about 3 months after surgery. Participants will attend approximately 24 visits and will be followed in a maintenance program for up to 5 years.
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This is a single-site, parallel-arm randomized clinical trial in adults with peri-implantitis requiring resective surgery. Participants will be assigned to resective surgery with implantoplasty or resective surgery with mechanical debridement only. Blood will be collected at baseline (pre-surgery), 48 hours post-surgery, and 2 weeks post-surgery. Saliva will be collected at baseline and 2 weeks post-surgery. Gingival tissue biopsies will be collected at baseline and 3 months post-surgery for spatial transcriptomic and histological analyses. An additional follow-up visit will occur at approximately 2 months post-surgery for reinforcement of oral hygiene instructions. Participants will then be followed in a structured supportive care program with visits every 3 months from Month 6 through Month 60.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be enrolled, the participant must met the following inclusion criteria:
To be enrolled in the maintenance phase, participants must meet clinical stability criteria at the time of enrollment:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Full-thickness mucoperiosteal flaps will be elevated, and granulation tissue will be removed using surgical curettes. The implant surface will be cleaned using mechanical debridement with titanium curettes and ultrasonic instruments. In the test group, implantoplasty will be performed using rotary instruments to smooth and reduce implant surface roughness. All implant surfaces will be irrigated with sterile saline before suturing. Flaps will then be repositioned and secured using single interrupted sutures.
Procedure: Resective surgery with implantoplasty
Full-thickness mucoperiosteal flaps will be elevated, and granulation tissue will be removed using surgical curettes. The implant surface will be cleaned using mechanical debridement with titanium curettes and ultrasonic instruments. In the control group, air polishing will be performed using the Airflow Prophylaxis Master with AIR-FLOW powder PLUS containing erythritol (14 µm), amorphous silica, and 0.3% chlorhexidine. All implant surfaces will be irrigated with sterile saline before suturing. Flaps will then be repositioned and secured using single interrupted sutures.
Procedure: Resective surgery with mechanical debridement
In the implantoplasty group, exposed implant surfaces not covered by bone will be mechanically smoothed using a resective approach aimed at reducing surface roughness. No osteoplasty will be performed. Implantoplasty will be carried out using oval-shaped tungsten carbide burs of progressively increasing diameter mounted on a rotary handpiece. Surface refinement will then be completed using white Arkansas stone burs, followed by polishing with brown and green silica polishing burs under copious saline irrigation. The implantoplasty procedure will be standardized to approximately 5 minutes per implant.
In the mechanical debridement group, visible calculus will be removed using an ultrasonic tip without direct contact with the implant surface. Implant surfaces will then be decontaminated using the Airflow Prophylaxis Master device with erythritol (14 μm), amorphous silica, and 0.3% chlorhexidine. The device will be operated at a static pressure of 5 bar with maximal water irrigation. No implantoplasty will be performed.
Mean change from baseline in peri-implant probing depth (millimeters)
Probing depth will be measured to the nearest 1 millimeter at 6 sites per implant (MB, B, DB, ML, L, DL) using a UNC-15 periodontal probe by a calibrated examiner.
Time frame: Baseline and 3 months post-surgery
Percentage of sites with bleeding on probing (percentage)
Bleeding on probing will be assessed at 6 sites per implant and summarized as the percentage of sites with bleeding.
Time frame: Baseline and 3 months post-surgery.
Modified Plaque Index (mPI) (score on a scale, 0-3; higher score = worse outcome)
Plaque accumulation will be assessed using the Modified Plaque Index (mPI) for dental implants, a 4-point ordinal scale where 0 = no detection of plaque / no visible plaque, 1 = plaque only recognized by running a probe across the marginal surface, 2 = plaque can be seen by the naked eye (\>25%), and 3 = abundance of soft matter. Scores range from 0 (minimum, best outcome) to 3 (maximum, worst outcome). Higher scores indicate greater plaque accumulation. Results will be summarized as the mean score per implant across the 6 sites assessed.
Time frame: Baseline and 3 months post-surgery
Modified sulcus bleeding index (score)
Peri-implant mucosal inflammation will be assessed using the modified sulcus bleeding index (mSBI) and summarized as the mean score per implant.
Time frame: Baseline and 3 months post-surgery
Marginal bone loss (millimeters)
Marginal bone level will be measured on standardized periapical radiographs as the distance from the implant platform to the first bone-to-implant contact at mesial and distal sites at both baseline and 3 months follow-up. Marginal bone loss will be determined as the difference between both timepoints.
Time frame: Baseline and 3 months post-treatment
Mean Width of Keratinized Mucosa (millimeters)
The width of keratinized mucosa (KM) will be measured in millimeters (mm) at the mid-buccal and mid-lingual aspects of each experimental implant using a UNC-15 probe.
Time frame: Baseline and 3 months post-surgery.
Disease resolution (dichotomic)
Disease resolution will be assessed for all implants and defined as: Absence of profuse BOP, absence of suppuration, PD ≤ 5 mm and absence of progressive bone loss compared to pre-treatment bone levels.
Time frame: 3 months, 12 months
Disease recurrence (dichotomic)
Assessed on all implants, defined as presence of profuse BOP and/or suppuration, increase in PPD, and progressive MBL of \> 0.5 mm compared to the previous examination.
Time frame: 2, 3, 4, and 5 years post-surgery
Cellular Composition of Peri-implant Tissue Assessed by Spatial Transcriptomics
Peri-implant tissue samples will undergo spatial transcriptomic analysis to characterize cellular composition and compare the peri-implant tissue microenvironment between treatment groups.
Time frame: Baseline and 3 months post-surgery
Change in Serum Cytokine, Chemokine, and Growth Factor Levels
Serum samples will be analyzed using a multiplex cytokine, chemokine, and growth factor panel on the Luminex system. Each analyte concentration will be assessed separately and compared between treatment groups and across collection time points.
Time frame: Baseline, 48 hours post-surgery, and 2 weeks post-surgery
Change in Salivary Protein Biomarker Levels
Unstimulated whole saliva samples will be analyzed using multiplex protein assays. Salivary biomarker levels will be compared between treatment groups and across collection time points.
Time frame: Baseline and 2 weeks post-surgery
Titanium Particle Density in Peri-implant Tissue (particles/mm²)
Titanium particles will be identified in peri-implant tissue. Particle density will be calculated as the number of confirmed titanium particles divided by the analyzed tissue area.
Time frame: Baseline and 3 months post-surgery
Percentage of Peri-implant Tissue Area Occupied by Titanium Particles
The area occupied by confirmed titanium particles will be measured using ImageJ/Fiji and expressed as a percentage of the analyzed tissue region of interest.
Time frame: Baseline and 3 months post-surgery
Plan to share: No — Research study data will be stored separately from medical records. Consent forms and copies of letters/correspondence will be stored separately from the research data. Data will be coded with a participant code number which will be assigned consecutively as subjects are enrolled. There will be an excel spreadsheet containing the linkage code to the identifiable patient name or Axium number. This spreadsheet will be password protected and only accessible to the research team and will be saved in a separate location then the medical records (such as OneDrive).
Started Feb 2026 (actual). Primary completion is estimated for Jun 2027, 16 months after the start.
Of 119 non-industry interventional studies with no phase under Peri-Implantitis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 16 months is below that.
Counting every sponsor, half of 126 studies reached it within 26 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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