An interventional study of GBO and GBG and Standard treatment in Peri-implantitis, sponsored by Geistlich Pharma AG. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Geistlich Pharma AG · Not applicable, Interventional, and Treatment
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.
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.
304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.
This study's enrollment of 71 is above the median of 40 across 182 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →Geistlich Pharma AG is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.2 g-0,5 g GBO and 1 GBG once after decontamination of implant surface
Device: GBO and GBG
Decontamination of surface of implant
Other: Standard treatment
Application of GBO and GBG to the defect fill after removal of chronic inflammatory tissue and decontamination of the surface of implant
Removal of chronic inflammatory tissue using titanium curettes and a rotary titanium brush; Implant Surface decontamination and closure by suturing
Change in the dimensions of the bone defect
Time frame: 6 months, 1 year
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
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Geistlich Pharma AG