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

NCT06708247 | Completed

• 1 other identifier: TUBER-GALVO-RCT
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implantitis; Peri-Implant Health; Peri-Implantational Loss; Peri-Implantation Loss

Keywords

peri-implantits; dental implants; bone grafting; Electrolytic cleaning

Outcome Measures

Primary Outcomes (1)

• Probing Pocket Depth (PPD)

  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.

  12 months

Secondary Outcomes (2)

• Bone Regeneration Assessed via Radiographic Analysis

  12 months

• Bleeding on Probing (BOP)

  12 months

Study Arms (2)

Standard Peri-implant Reconstructive Therapy

ACTIVE COMPARATOR

Participants in this arm receive standard peri-implant reconstructive therapy for the management of peri-implantitis. This includes mechanical debridement of the implant surface, bone grafting using autogenous bone from the tuberosity, and the use of a resorbable collagen membrane to promote bone regeneration. The intervention aims to reduce inflammation, improve bone regeneration, and stabilize the implant site.

Procedure: Standard Peri-implant Reconstructive Surgery

Peri-implant Reconstructive Therapy with Electrolytic Cleaning

EXPERIMENTAL

Participants in this arm undergo peri-implant reconstructive therapy combined with electrolytic cleaning for enhanced decontamination of the implant surface. This includes mechanical debridement, electrolytic cleaning to remove biofilm and contaminants while preserving the implant surface, followed by bone grafting using autogenous bone from the tuberosity and coverage with a resorbable collagen membrane. This intervention is intended to improve clinical outcomes, enhance bone regeneration, and achieve better implant stability compared to the standard therapy alone.

Procedure: Electrolytic Cleaning with Peri-implant Reconstructive Surgery

Interventions

Standard Peri-implant Reconstructive Surgery PROCEDURE

This intervention involves standard peri-implant reconstructive surgery without the additional step of electrolytic cleaning. The procedure includes mechanical debridement of the implant surface to remove biofilm, followed by bone grafting using autogenous bone harvested from the tuberosity and coverage with a resorbable collagen membrane for bone regeneration and stabilization of the implant.

Standard Peri-implant Reconstructive Therapy

Electrolytic Cleaning with Peri-implant Reconstructive Surgery PROCEDURE

This intervention involves peri-implant reconstructive surgery with an added step of electrolytic cleaning for enhanced implant surface decontamination. The procedure starts with mechanical debridement of the implant surface, followed by the use of an electrolytic cleaning device to remove biofilm and contaminants without damaging the implant surface. This is then followed by bone grafting using autogenous tuberosity bone and coverage with a resorbable collagen membrane to promote bone regeneration and implant stability.

Peri-implant Reconstructive Therapy with Electrolytic Cleaning

Eligibility Criteria

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

You may qualify if:

• 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.
• \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vilniaus Implantologijos Centro (VIC) Klinika: lead

Study Sites (1)

VIC Clinic

Vilnius, 03162, Lithuania

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This study follows a parallel interventional model where participants are randomly assigned to one of two groups. The control group receives standard peri-implant reconstructive therapy involving mechanical debridement and bone grafting with autogenous tuberosity bone. The test group undergoes the same reconstructive therapy but includes an additional intervention of electrolytic cleaning for implant surface decontamination. Both groups are monitored concurrently over a 12-month period to assess clinical and radiographic outcomes, such as probing pocket depth reduction and bone regeneration. This model allows for a direct comparison of treatment efficacy between the two intervention strategies.

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: June 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available starting 6 months after publication of the main study results. Data will be available for a period of 5 years after the initial release.
• Access Criteria: Qualified researchers with a valid research proposal related will be able to access the de-identified individual participant data (IPD) and supporting information. Researchers must submit a written request to the corresponding author, detailing the purpose and methodology of their proposed study. Access will be granted upon approval by the research team and will require a signed data use agreement to ensure confidentiality and proper data usage. Data will be provided in a secure format through an encrypted electronic transfer or a secure data-sharing platform.

Locations

LI (1)