Peri-implantitis Management: Surgical and Maintenance Outcomes

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Resective surgery with implantoplasty
  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 pro
• Процедура Resective surgery with mechanical debridement
  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

Первичные конечные точки

• Mean change from baseline in peri-implant probing depth (millimeters) [Срок оценки: Baseline and 3 months post-surgery]

Вторичные конечные точки (12)

• Percentage of sites with bleeding on probing (percentage) [Срок оценки: Baseline and 3 months post-surgery.]
• Modified Plaque Index (mPI) (score on a scale, 0-3; higher score = worse outcome) [Срок оценки: Baseline and 3 months post-surgery]
• Modified gingival index (score) [Срок оценки: Baseline and 3 months post-surgery]
• Implant mucosal index (IMI) (score on a scale, 0-4; higher score = worse outcome) [Срок оценки: Baseline and 3 months post-surgery]
• Mean change from baseline in marginal bone level (millimeters) [Срок оценки: Baseline and 3 months post-treatment]
• Mean width of keratinized mucosa [Срок оценки: Baseline and 3 months post-surgery.]
• Elastase activity in peri-implant crevicular fluid [Срок оценки: Baseline and 3 months post-surgery]
• Alpha-2-macroglobulin level in peri-implant crevicular fluid [Срок оценки: Baseline and 3 months post-surgery]
• Alkaline phosphatase activity in peri-implant crevicular fluid [Срок оценки: Baseline and 3 months post-surgery]
• Interleukin-1 beta level in peri-implant crevicular fluid [Срок оценки: Baseline and 3 months post-surgery]
• Bray-Curtis dissimilarity of submucosal plaque microbial communities [Срок оценки: 3 months post surgery]
• Systemic immune clonal overlap frequency [Срок оценки: Baseline and 2 weeks post-surgery.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pittsburgh School of Dental Medicine — Pittsburgh

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07550127 · STUDY25070066

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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