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Peri-implantitisNCT07550127

Peri-implantitis Management: Surgical and Maintenance Outcomes

A study testing Resective surgery with implantoplasty and Resective surgery with mechanical debridement in people with Peri-implantitis, run by University of Pittsburgh at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. 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?
Resective surgery with implantoplasty and Resective surgery with mechanical debridement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
16 Feb 2026to 30 Jun 2029
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

  • To be enrolled, the participant must met the following inclusion criteria:
  • Aged 18 or older.
  • In good general health, classified as ASA Physical Status I or II.
  • Diagnosed with peri-implantitis requiring resective surgical treatment, characterized by: Bleeding on probing (BOP) around dental implants. Probing pocket depths (PPD) greater than 6 mm. Implants in function for over 1 year with progressive bone loss exceeding 3 mm. Initial screening confirmed by panoramic radiographs, cone-beam computed tomography (CBCT), and clinical diagnosis.
  • To be enrolled in the maintenance phase, participants must meet clinical stability criteria at the time of enrollment:
  • Probing depth (PD) ≤ 5 mm
Show all 9Show fewer
  • Bleeding on probing (BOP) ≤ 1 point
  • Absence of suppuration (SOP)
  • Absence of progressive bone loss compared to pre-treatment bone levels

Who cannot join

  • Patients with autoimmune or systemic inflammatory diseases (e.g., lupus, rheumatoid arthritis) that could alter immune cell profiles independent of local peri-implant inflammation.
  • Chronic use of systemic corticosteroids or immunosuppressants within the past 3 months.
  • Uncontrolled diabetes (HbA1c > 7.5%) due to its potential impact on healing and immune response.
  • Active infection or antibiotic use in the 30 days prior to baseline sampling.
  • Pregnancy or breastfeeding.
  • Inability to undergo venipuncture or tolerate soft tissue biopsy.
  • Inability to attend the 3-month follow-up visit or comply with study protocol.
  • History of malignancy requiring systemic therapy within the past 5 years.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrea Ravida, DDS, MS, PhD contact

7347309678

andrearavida@pitt.edu

Carla Sanchez, MS contact

4126241179

cab28@pitt.edu

United States1 site, 1 recruiting

  • University of Pittsburgh School of Dental Medicine

    Pittsburgh, Pennsylvania, 15213

    Andrea Ravida, DDS, MS, PhD

    Recruiting

Other trials in United States

About this study

Official title: Impact of Implantoplasty on Local and Systemic Inflammation in Peri-implantitis: A Randomized Controlled Trial

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.

Show more lines

Read the detailed description

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.

Being tested
Resective surgery with implantoplasty, Resective surgery with mechanical debridement
Keywords
Peri-implantitis, Implantoplasty, Spatial transcriptomics, Salivary biomarkers
Medical subject headings
Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resective surgery with implantoplastyProcedure or surgery

    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.

  • Resective surgery with mechanical debridementProcedure or surgery

    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.

Study groups in NCT07550127
Study groupRoleWhat they receive
Resective surgery with implantoplastyExperimentalFull-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.
Receives: Procedure: Resective surgery with implantoplasty
Resective surgery with mechanical debridementActive comparatorFull-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.
Receives: Procedure: Resective surgery with mechanical debridement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 3 months post-surgery

Secondary outcomes (12)

  1. 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.

    Measured: Baseline and 3 months post-surgery.

  2. 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.

    Measured: Baseline and 3 months post-surgery

  3. 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.

    Measured: Baseline and 3 months post-surgery

  4. 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.

    Measured: Baseline and 3 months post-treatment

  5. 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.

    Measured: Baseline and 3 months post-surgery.

  6. 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.

    Measured: 3 months, 12 months

  7. 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.

    Measured: 2, 3, 4, and 5 years post-surgery

  8. 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.

    Measured: Baseline and 3 months post-surgery

  9. 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.

    Measured: Baseline, 48 hours post-surgery, and 2 weeks post-surgery

  10. 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.

    Measured: Baseline and 2 weeks post-surgery

  11. 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.

    Measured: Baseline and 3 months post-surgery

  12. 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.

    Measured: Baseline and 3 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study start16 Feb 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

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
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07550127
Sponsor's protocol ID
STUDY25070066
Status last verified
Sep 2026
First submitted
9 Apr 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

Publications

  • Suarez-Lopez Del Amo F, Garaicoa-Pazmino C, Fretwurst T, Castilho RM, Squarize CH. Dental implants-associated release of titanium particles: A systematic review. Clin Oral Implants Res. 2018 Nov;29(11):1085-1100. doi: 10.1111/clr.13372. Epub 2018 Oct 2.

    PubMed 30280418

  • Romeo E, Ghisolfi M, Murgolo N, Chiapasco M, Lops D, Vogel G. Therapy of peri-implantitis with resective surgery. A 3-year clinical trial on rough screw-shaped oral implants. Part I: clinical outcome. Clin Oral Implants Res. 2005 Feb;16(1):9-18. doi: 10.1111/j.1600-0501.2004.01084.x.

    PubMed 15642026

  • Ravida A, Siqueira R, Saleh I, Saleh MHA, Giannobile A, Wang HL. Lack of Clinical Benefit of Implantoplasty to Improve Implant Survival Rate. J Dent Res. 2020 Nov;99(12):1348-1355. doi: 10.1177/0022034520944158. Epub 2020 Jul 27.

    PubMed 32718212

  • Mombelli A, Hashim D, Cionca N. What is the impact of titanium particles and biocorrosion on implant survival and complications? A critical review. Clin Oral Implants Res. 2018 Oct;29 Suppl 18:37-53. doi: 10.1111/clr.13305.

    PubMed 30306693

  • Ichioka Y, Derks J, Larsson L, Berglundh T. Surface decontamination of explanted peri-implantitis-affected implants. J Clin Periodontol. 2023 Aug;50(8):1113-1122. doi: 10.1111/jcpe.13836. Epub 2023 Jun 4.

    PubMed 37271864

  • Herrera D, Berglundh T, Schwarz F, Chapple I, Jepsen S, Sculean A, Kebschull M, Papapanou PN, Tonetti MS, Sanz M; EFP workshop participants and methodological consultant. Prevention and treatment of peri-implant diseases-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2023 Jun;50 Suppl 26:4-76. doi: 10.1111/jcpe.13823. Epub 2023 Jun 4.

    PubMed 37271498

  • Goh R, Li KC, Atieh MA, Ma S, Oliver A, Giraldo D, Tawse-Smith A. The Effect of Implantoplasty on Fracture Resistance and Implant Surface Changes: An In Vitro and Finite Element Analysis Study. Clin Implant Dent Relat Res. 2025 Feb;27(1):e13409. doi: 10.1111/cid.13409. Epub 2024 Nov 6.

    PubMed 39506335

  • Chen L, Tong Z, Luo H, Qu Y, Gu X, Si M. Titanium particles in peri-implantitis: distribution, pathogenesis and prospects. Int J Oral Sci. 2023 Nov 23;15(1):49. doi: 10.1038/s41368-023-00256-x.

    PubMed 37996420

  • Bullon P, Fioroni M, Goteri G, Rubini C, Battino M. Immunohistochemical analysis of soft tissues in implants with healthy and peri-implantitis condition, and aggressive periodontitis. Clin Oral Implants Res. 2004 Oct;15(5):553-9. doi: 10.1111/j.1600-0501.2004.01072.x.

    PubMed 15355397

  • Bollen CM, Papaioanno W, Van Eldere J, Schepers E, Quirynen M, van Steenberghe D. The influence of abutment surface roughness on plaque accumulation and peri-implant mucositis. Clin Oral Implants Res. 1996 Sep;7(3):201-11. doi: 10.1034/j.1600-0501.1996.070302.x.

    PubMed 9151584

  • Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

    PubMed 29926491

Questions about this trial

What is this clinical trial studying?

A study testing Resective surgery with implantoplasty and Resective surgery with mechanical debridement in people with Peri-implantitis, run by University of Pittsburgh 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 9 inclusion and 8 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 10 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?

Contact Andrea Ravida, DDS, MS, PhD (7347309678, andrearavida@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in peri-implant probing depth (millimeters) (time frame: Baseline and 3 months post-surgery). 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 NCT07550127, which also lists 11 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 10 Sep 2026.

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