Peri-implantitis Management: Surgical and Maintenance Outcomes
Impact of Implantoplasty on Local and Systemic Inflammation in Peri-implantitis: A Randomized Controlled Trial
1 other identifier
interventional
44
1 country
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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2026
CompletedFirst Submitted
Initial submission to the registry
April 9, 2026
CompletedFirst Posted
Study publicly available on registry
April 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2029
September 10, 2026
September 1, 2026
1.4 years
April 9, 2026
September 7, 2026
Conditions
Keywords
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 sulcus bleeding index (score)
Baseline and 3 months post-surgery
Marginal bone loss (millimeters)
Baseline and 3 months post-treatment
Mean Width of Keratinized Mucosa (millimeters)
Baseline and 3 months post-surgery.
- +7 more secondary outcomes
Study Arms (2)
Resective surgery with implantoplasty
EXPERIMENTALFull-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.
Resective surgery with mechanical debridement
ACTIVE 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.
Interventions
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh School of Dental Medicine
Pittsburgh, Pennsylvania, 15213, United States
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: 30280418BACKGROUNDRomeo 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: 15642026BACKGROUNDRavida 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: 32718212BACKGROUNDMombelli 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: 30306693BACKGROUNDIchioka 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: 37271864BACKGROUNDHerrera 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: 37271498BACKGROUNDGoh 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: 39506335BACKGROUNDChen 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: 37996420BACKGROUNDBullon 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: 15355397BACKGROUNDBollen 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: 9151584BACKGROUNDBerglundh 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: 29926491BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Ravida, DDS, MS, PhD
University of Pittsburgh, Department of Periodontics and Oral Medicine.
Central Study Contacts
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
September 10, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
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).