Peri-implantitis Management: Surgical and Maintenance Outcomes

NCT07550127 | Recruiting

• 1 other identifier: STUDY25070066
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. Participants will provide blood samples before surgery, about 48 hours and 2 weeks after surgery. Participants will also provide a small gum tissue sample and fluid from around the implant at baseline and about 3 months after surgery. Participants will be followed in a maintenance program for up to 5 years.

Conditions

Peri-implantitis

Keywords

Peri-implantitis; Implantoplasty; Single-cell RNA sequencing

Outcome Measures

Primary Outcomes (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.

  Baseline and 3 months post-surgery

Secondary Outcomes (12)

• Percentage of sites with bleeding on probing (percentage)

  Baseline and 3 months post-surgery.

• Modified Plaque Index (mPI) (score on a scale, 0-3; higher score = worse outcome)

  Baseline and 3 months post-surgery

• Modified gingival index (score)

  Baseline and 3 months post-surgery

• Implant mucosal index (IMI) (score on a scale, 0-4; higher score = worse outcome)

  Baseline and 3 months post-surgery

• Mean change from baseline in marginal bone level (millimeters)

  Baseline and 3 months post-treatment

Study Arms (2)

Resective surgery with implantoplasty

EXPERIMENTAL

Full thickness mucoperiosteal flaps will be elevated, and granulation tissue will be removed using surgical curettes. Hard deposits will be debrided with plastic-tipped universal curettes, and all sites will be irrigated with 20 mL of sterile saline. Exposed and accessible titanium implant surfaces will be polished to reduce macro- and micro-roughness and eliminate bacterial biofilm. No osteoplasty will be performed. Polishing will be carried out with round diamond burs (30 µm grit; diameters 1.8, 2.3, and 3.5 mm) at 15,000 rpm under continuous saline irrigation, standardized to \~5 minutes per implant. Surgical sites will be irrigated thoroughly with sterile saline to eliminate remaining granulation tissue, titanium debris, or polishing particles. Flaps will then be repositioned and secured using single interrupted sutures to allow for optimal healing.

Procedure: Resective surgery with implantoplasty

Resective surgery with mechanical debridement

ACTIVE COMPARATOR

Full thickness mucoperiosteal flaps will be elevated and granulation tissue removed using surgical curettes. Hard deposits will be debrided with plastic-tipped universal curettes and sites irrigated with 20 mL sterile saline. Implant surfaces will be decontaminated by submucosal air-polishing with the Airflow Prophylaxis Master (EMS) using AIR-FLOW powder PLUS (erythritol 14 µm, amorphous silica, 0.3% chlorhexidine) at full power with irrigation. The nozzle will be changed after each implant and the handpiece moved along threads from apical to coronal positions; angulation/working distance not standardized. Surgical sites will be irrigated thoroughly with sterile saline to remove residual granulation tissue, titanium debris, or polishing particles. Flaps will then be repositioned and secured using single interrupted sutures to allow for optimal healing.

Procedure: Resective surgery with mechanical debridement

Interventions

Resective surgery with implantoplasty PROCEDURE

In the implantoplasty group, exposed and accessible titanium implant surfaces will be polished using a resective approach aimed at mechanically reducing macro- and micro-roughness to eliminate bacterial biofilm. No osteoplasty will be performed to avoid unnecessary soft tissue recession. Polishing will be carried out with round diamond burs (30 µm grit; diameters 1.8, 2.3, and 3.5 mm) mounted on a rotary handpiece operating at 15,000 rpm under continuous saline irrigation. The implantoplasty procedure will be standardized to approximately 5 minutes per implant.

Resective surgery with implantoplasty

Resective surgery with mechanical debridement PROCEDURE

Hard deposits will be debrided with plastic-tipped universal curettes, and all sites will be irrigated with 20 mL of sterile saline. In the control group, implant surfaces will be decontaminated using submucosal air-polishing with the Airflow Prophylaxis Master device. Copious saline irrigation will be performed prior to implant decontamination. Air-polishing will be carried out using AIR-FLOW powder PLUS, which contains erythritol (sugar alcohol, 14 µm), amorphous silica, and 0.3% chlorhexidine. The device will be set to full power with irrigation. After decontamination, surgical sites will be irrigated thoroughly with sterile saline to remove any residual granulation tissue, titanium debris, or polishing particles

Resective surgery with mechanical debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Bleeding on probing (BOP) ≤ 1 point
• Absence of suppuration (SOP)
• Absence of progressive bone loss compared to pre-treatment bone levels

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh School of Dental Medicine

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (11)

• 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.

  PMID: 30280418 BACKGROUND

• 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.

  PMID: 15642026 BACKGROUND

• 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.

  PMID: 32718212 BACKGROUND

• 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.

  PMID: 30306693 BACKGROUND

• 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.

  PMID: 37271864 BACKGROUND

• 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.

  PMID: 37271498 BACKGROUND

• 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.

  PMID: 39506335 BACKGROUND

• 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.

  PMID: 37996420 BACKGROUND

• 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.

  PMID: 15355397 BACKGROUND

• 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.

  PMID: 9151584 BACKGROUND

• 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.

  PMID: 29926491 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Ravida, DDS, MS, PhD

  University of Pittsburgh, Department of Periodontics and Oral Medicine.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Ravida, DDS, MS, PhD

CONTACT

7347309678; andrearavida@pitt.edu

Carla Sanchez, MS

CONTACT

4126241179; cab28@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, DDS, MS, PhD

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 24, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)