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

NCT06708247 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-11-27

No results posted yet for this study

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

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Vilniaus Implantologijos Centro (VIC) Klinika

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06708247 on ClinicalTrials.gov