Peri-implantitis - Reconstructive Surgical Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Open flap debridement: Open flap debridement using saline as irrigation

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

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.

Eligibility

Primary outcome measure(s)

• Treatment success (year 1) — 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) — 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) — Assessed at year 5
  Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm

Trial sites (1)

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