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

NCT ID: NCT06708247

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard Peri-implant Reconstructive Therapy

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.

Group Type ACTIVE_COMPARATOR

Standard Peri-implant Reconstructive Surgery

Intervention Type 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.

Peri-implant Reconstructive Therapy with Electrolytic Cleaning

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.

Group Type EXPERIMENTAL

Electrolytic Cleaning with Peri-implant Reconstructive Surgery

Intervention Type 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.

Interventions

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Standard Peri-implant Reconstructive Surgery

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.

Intervention Type PROCEDURE

Electrolytic Cleaning with Peri-implant Reconstructive Surgery

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vilniaus Implantologijos Centro (VIC) Klinika

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VIC Clinic

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

Other Identifiers

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TUBER-GALVO-RCT

Identifier Type: -

Identifier Source: org_study_id