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Peri-implantitis - Reconstructive Surgical Therapy

NCT03077061 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-10-15

No results posted yet for this study

Summary

The project will evaluate the potential benefit of the use of bone replacement graft as an adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients diagnosed with peri-implantitis will randomly assigned to be treated with or without bone replacement graft. Outcome measures include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.

Conditions

  • Peri-Implantitis

Interventions

PROCEDURE

Open flap debridement

Open flap debridement using saline as irrigation

DEVICE

Bone replacement graft

Open flap debridement using saline as irrigation including a grafting procedure withBio-Oss Collagen®.

Sponsors & Collaborators

  • Osteology Foundation

    collaborator OTHER

  • Göteborg University

    lead OTHER

Principal Investigators

  • Tord Berglundh, Professor · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2022-03-14
Completion
2026-03-14

Countries

  • Sweden

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 NCT03077061 on ClinicalTrials.gov