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Active Not Recruiting
NCT03077061
Peri-implantitis - Reconstructive Surgical Therapy
Conditions: Peri-Implantitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Göteborg University
Location: Department of Periodontology, Institute of Odontology Gothenburg
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT03077061). StuddyBuddy aggregates publicly available trial information.