Reconstructive Therapy for Peri-implantitis Using Tuberosity Bone with or Without Electrolytic Cleaning: a Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Peri-implantitis; Peri-Implant Health; Peri-Implantational Loss; Peri-Implantation Loss

• Registration Number: NCT06708247
• Lead Sponsor: Vilniaus Implantologijos Centro (VIC) Klinika

Brief Summary

This study aims to evaluate the effectiveness of two surgical approaches for managing peri-implantitis, a condition characterized by inflammation and bone loss around dental implants. Participants will be randomly assigned to one of two groups: one group will receive standard peri-implant reconstructive therapy using bone grafts from the tuberosity region, and the other group will undergo the same treatment with the addition of electrolytic cleaning to decontaminate the implant surface. The primary objective is to determine whether adding electrolytic cleaning improves treatment outcomes by promoting better decontamination and bone regeneration. Clinical assessments, including probing depth measurements and radiographic analysis, will be performed at baseline and at follow-up intervals over 12 months. The study's hypothesis is that the use of electrolytic cleaning alongside standard reconstructive therapy will result in superior clinical and radiographic outcomes compared to the standard method alone.

Detailed Description

This randomized clinical trial investigates the effectiveness of reconstructive therapy for peri-implantitis using autogenous bone grafts from the tuberosity, with and without the addition of electrolytic cleaning for implant surface decontamination. Peri-implantitis, an inflammatory condition that results in bone loss around dental implants, poses significant challenges for successful long-term management. Traditional treatment methods focus on mechanical decontamination and bone regeneration, but the outcomes have been inconsistent due to difficulties in achieving thorough surface cleaning without damaging the implant.

This study involves patients diagnosed with peri-implantitis who will be randomly assigned to either the control group or the test group. The control group will undergo conventional treatment, which includes mechanical debridement and grafting with autogenous bone harvested from the tuberosity, covered by a resorbable collagen membrane. The test group will receive an additional step of electrolytic cleaning using a novel electrochemical device designed to decontaminate the implant surface without causing structural damage. This method leverages reactive oxygen species to aid in biofilm disruption and removal.

The trial's primary outcome measures include the reduction in probing pocket depth (PPD) and bleeding on probing (BOP) as well as radiographic assessments of bone regeneration at various time points, up to 12 months post-surgery. Secondary outcomes include patient-reported pain levels, surgical site healing, and the overall stability of bone and soft tissue.

Pre-surgical procedures involve thorough oral hygiene protocols, mechanical debridement, and local application of chlorhexidine and antibiotics. Surgical treatment follows standard implant exposure and flap design techniques, with bone grafts obtained from the tuberosity. For the test group, electrolytic cleaning will be performed prior to graft placement. Post-surgical care includes antibiotics, pain management, and specific oral hygiene instructions to ensure optimal healing.

The study seeks to address the hypothesis that incorporating electrolytic cleaning enhances implant surface decontamination, thus improving clinical outcomes and facilitating more predictable bone regeneration. The findings aim to contribute to the growing body of literature on peri-implantitis management and provide evidence for more effective treatment strategies that preserve implant integrity and support long-term success.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Participants aged 18 years or older.

Diagnosed with peri-implantitis, 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.

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Exclusion Criteria

Individuals with uncontrolled medical conditions or systemic diseases. Pregnant women. Smokers who smoke more than 10 cigarettes per day. Presence of implant mobility. Situations where the removal of the implant suprastructure is not possible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Probing Pocket Depth (PPD)	12 months	The primary outcome measure for this study is the reduction in probing pocket depth (PPD) at a 12-month follow-up. PPD is measured at four sites (mesial, distal, buccal, and lingual) around the affected implants to assess the success of treatment in reducing the depth of periodontal pockets. A significant decrease in PPD indicates effective treatment and improved implant health. Clinical probing is performed by a blinded examiner using a standardized periodontal probe to ensure consistency and reliability. Measurements taken at baseline and at 12 months post-surgery will be compared to evaluate the effectiveness of both the standard reconstructive therapy and the therapy with added electrolytic cleaning.

Secondary Outcome Measures

Name	Time	Method
Bone Regeneration Assessed via Radiographic Analysis	12 months	Bone regeneration is assessed using standardized radiographic analysis to measure changes in bone levels around the treated implants. Radiographs taken at baseline and at the 12-month follow-up will be analyzed to quantify the amount of new bone formed. Measurements will be conducted at four points (mesial, distal, buccal, and lingual) relative to the implant shoulder. This outcome helps determine the efficacy of the interventions in supporting bone regeneration and stabilizing the implant environment.
Bleeding on Probing (BOP)	12 months	This outcome measures the presence of bleeding on probing around the treated implants at baseline and 12 months post-surgery. BOP is a key indicator of gingival inflammation and peri-implant health. Reduction in BOP signifies improved periodontal status and successful treatment.

Trial Locations

Locations (1)

VIC Clinic; 🇱🇹 Vilnius, Lithuania