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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBO and GBG | Experimental | 0.2 g-0,5 g GBO and 1 GBG once after decontamination of implant surface |
|
| Standard treatment | Active Comparator | Decontamination of surface of implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBO and GBG | Device | Application of GBO and GBG to the defect fill after removal of chronic inflammatory tissue and decontamination of the surface of implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the dimensions of the bone defect | 6 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pocket depth | 3 months,6months, 9 months,12months | |
| Change in gingival inflammation | 3 months,6months, 9 months,12months | |
| Changes in recession of the mucosal margin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Renvert, Professor | Department of Health Sciences, Kristianstad University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kristianstad University, Department of Health Sciences | Kristianstad | 29188 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39020503 | Derived | Renvert S, Giovannoli JL, Rinke S. The efficacy of reconstructive therapy in the surgical management of peri-implantitis: A 3-year follow-up of a randomized clinical trial. J Clin Periodontol. 2024 Oct;51(10):1267-1276. doi: 10.1111/jcpe.14049. Epub 2024 Jul 17. | |
| 34169551 | Derived | Renvert S, Giovannoli JL, Roos-Jansaker AM, Rinke S. Surgical treatment of peri-implantitis with or without a deproteinized bovine bone mineral and a native bilayer collagen membrane: A randomized clinical trial. J Clin Periodontol. 2021 Oct;48(10):1312-1321. doi: 10.1111/jcpe.13513. Epub 2021 Jul 29. |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Standard treatment | Other | Removal of chronic inflammatory tissue using titanium curettes and a rotary titanium brush; Implant Surface decontamination and closure by suturing |
|
| 3 months,6months, 9 months,12months |
| Subject satisfaction with the outcome at the study end | 12months |