Clinical trial NCT06708247: Reconstructive Therapy for Peri-implantitis Using Tuberosity Bone with or Without Electrolytic Cleaning: a Randomized Clinical Trial
Official title: Peri-implant Reconstructive Therapy with Tuberosity Bone with and Without Electrolytic Cleaning in the Surgical Management of Peri-implantitis: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-implantitis
Peri-Implant Health
Peri-Implantational Loss
Peri-Implantation Loss
Keywords: peri-implantits
dental implants
bone grafting
Electrolytic cleaning
Lead sponsor: Vilniaus Implantologijos Centro (VIC) Klinika
Sponsor class: NETWORK
First posted: 2024-11-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Probing Pocket Depth (PPD)
timeFrame: 12 months
Secondary outcomes:
measure: Bone Regeneration Assessed via Radiographic Analysis
timeFrame: 12 months
measure: Bleeding on Probing (BOP)
timeFrame: 12 months
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: VIC Clinic
Study officials:
References: