Clinical Trial: Treatment of Peri-implantitis Lesions by Using Biomaterial
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Surgical Treatment of Peri-implantitis Lesions, With or Without the Placement of a Bone Substitute and a Collagen Membrane. A Randomized Clinical Trial
Brief Summary: The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease.
Detailed Summary:
Patient who will considered eligible at the screening visit will undergo surgical treatment procedure within 2 weeks. At the day of the surgery the patients will be randomized into the 2 treatment groups.
The subjects will be then prescribed postoperative antibiotics (Azitromax 500 mg day one and 250 mg day 2-4).
Post-operative pain will be controlled with Ibuprofen (400mg x 3) for two days to all subjects. Subjects will rinse twice daily with Chlorhexidine mouth rinse and use modified oral hygiene procedures during the first 5 weeks of healing. Subjects will receive professional prophylaxis as required.
Subjects will be instructed on appropriate oral hygiene throughout the study and will be given appropriate oral hygiene instructions. Instructions on post-operative care will be repeated at each visit. In particular the following points have to be covered during the first month after surgery: Chlorhexidine rinses, avoidance of brushing, usage of interdental cleaning devices, avoidance of chewing on or trauma to the treated area. In addition subjects will be instructed not to smoke more than 10 cigarettes per day during the entire study period and not to consume alcohol during antibiotic therapy.
Sutures will be removed after 14 days. Photos will be taken during the whole study to document the healing process.
Further follow up visits will be scheduled 6 weeks and 3,6,9,12 months post-surgery.
Sponsor: Geistlich Pharma AG
Current Primary Outcome: Change in the dimensions of the bone defect [ Time Frame: 6 months, 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in pocket depth [ Time Frame: 3 months,6months, 9 months,12months ]
- Change in gingival inflammation [ Time Frame: 3 months,6months, 9 months,12months ]
- Changes in recession of the mucosal margin [ Time Frame: 3 months,6months, 9 months,12months ]
- Subject satisfaction with the outcome at the study end [ Time Frame: 12months ]
Original Secondary Outcome: Same as current
Information By: Geistlich Pharma AG
Dates:
Date Received: July 7, 2014
Date Started: September 2014
Date Completion: April 2017
Last Updated: August 8, 2016
Last Verified: August 2016
