Clinical Trial: Peri-implantitis - Reconstructive Surgical Therapy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Reconstructive Surgical Therapy of Peri-implantitis-related Osseous Defects. A Multicenter Randomized Controlled Clinical Trial

Brief 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.

Detailed Summary:

Objective The overall objective of the project is to evaluate the clinical efficacy of the use of a bone substitute material in reconstructive surgical therapy of peri-implantitis-associated osseous defects.

Hypothesis: The use of a bone substitute material in reconstructive therapy of peri-implantitis increases the likelihood to achieve treatment success.

Relevance for clinical practice The project will provide significant contribution to the understanding of outcomes using reconstructive procedures in treatment of peri-implantitis.

Study population, design and treatment procedures 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 with implants ≥1 year in function and diagnosed with advanced peri-implantitis at ≥1 implants will be enrolled.

Inclusion criteria Age ≥ 18 years

≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus. Confirmed bone loss ≥3 mm at same implant(s)

Exclusion criteria Treated for peri-implantitis during previous 6 months Intake of systemic or local antibiotics during previous 6 months Systemic conditions affecting peri-implant tissues Systemic conditions impeding surgical intervention

Surgical procedures Surgical procedures will be performed one month after a baseline examination and initiation of plaque control. Three days before surgery a 10-day systemic antibiotic regimen will be initiated. Full thickness flaps will be elevated and inflamed tissues will be removed. The implant surfaces w
Sponsor: Göteborg University

Current Primary Outcome:

• Treatment success (year 1) [ Time Frame: Assessed at year 1 ]
  Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin
• Treatment success (year 3) [ Time Frame: Assessed at year 3 ]
  Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin
• Treatment success (year 5) [ Time Frame: Assessed at year 5 ]
  Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Radiographic outcomes [ Time Frame: Assessed at 1, 3 and 5 years ]
  Defect fill and crestal bone support
• Patient-reported outcomes [ Time Frame: Prior to intervention and at 1, 3 and 5 years ]
  Patient-reported outcomes assessed by questionnaire and in relation to baseline

Original Secondary Outcome: Same as current

Information By: Göteborg University

Dates:
Date Received: February 24, 2017
Date Started: April 1, 2017
Date Completion: April 1, 2023
Last Updated: April 25, 2017
Last Verified: April 2017