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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.
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. Gingival tissue biopsy and peri-implant crevicular fluid (PICF) will be collected at baseline and 3 months post-surgery. Participants will then be followed in a structured supportive care program with visits every 3 months from month 6 to month 60.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 3 months post-surgery. |
| Modified Plaque Index (mPI) (score on a scale, 0-3; higher score = worse outcome) |
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Inclusion Criteria
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Ravida, DDS, MS, PhD | Contact | 7347309678 | andrearavida@pitt.edu | |
| Carla Sanchez, MS | Contact | 4126241179 | cab28@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Ravida, DDS, MS, PhD | University of Pittsburgh, Department of Periodontics and Oral Medicine. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh School of Dental Medicine | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30280418 | Background | 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. | |
| 15642026 | 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. |
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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).
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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 |
|
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. |
| Baseline and 3 months post-surgery |
| Modified gingival index (score) | Peri-implant mucosal inflammation will be assessed using the modified gingival index (mGI) and summarized as the mean score per implant. | Baseline and 3 months post-surgery |
| Implant mucosal index (IMI) (score on a scale, 0-4; higher score = worse outcome) | Peri-implant mucosal inflammation will be assessed using the Implant Mucosal Index, a 5-point ordinal scale based on light probing where 0 = no bleeding, 1 = minimal single-point bleeding, 2 = moderate multipoint bleeding, 3 = profuse multipoint bleeding, and 4 = suppuration. Scores range from 0 (minimum, best outcome) to 4 (maximum, worst outcome). Higher scores indicate more severe peri-implant inflammation. Results will be summarized as the worst score per implant across the 6 sites assessed. | Baseline and 3 months post-surgery |
| Mean change from baseline in marginal bone level (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; values will be averaged. | Baseline and 3 months post-treatment |
| Mean width of keratinized mucosa | 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. | Baseline and 3 months post-surgery. |
| Elastase activity in peri-implant crevicular fluid | Elastase activity will be quantified in PICF using a fluorogenic substrate assay and reported per collected sample. | Baseline and 3 months post-surgery |
| Alpha-2-macroglobulin level in peri-implant crevicular fluid | Alpha-2-macroglobulin will be measured in PICF by ELISA and reported per collected sample. | Baseline and 3 months post-surgery |
| Alkaline phosphatase activity in peri-implant crevicular fluid | Alkaline phosphatase activity will be measured in PICF using p-nitrophenyl phosphate as substrate and reported per collected sample. | Baseline and 3 months post-surgery |
| Interleukin-1 beta level in peri-implant crevicular fluid | Interleukin-1 beta will be measured in PICF using a multiplex immunoassay and reported per collected sample. | Baseline and 3 months post-surgery |
| Bray-Curtis dissimilarity of submucosal plaque microbial communities | Microbial community differences will be summarized using Bray-Curtis dissimilarity calculated from 16S rRNA sequencing profiles. | 3 months post surgery |
| Systemic immune clonal overlap frequency | The frequency of overlapping immune cell clones will be assessed by comparing single-cell RNA sequencing profiles from peripheral blood and gingival tissue biopsies. | Baseline and 2 weeks post-surgery. |
| 32718212 | 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. |
| 30306693 | 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. |
| 37271864 | 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. |
| 37271498 | 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. |
| 39506335 | 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. |
| 37996420 | 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. |
| 15355397 | 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. |
| 9151584 | 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. |
| 29926491 | 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. |