Kristianstad University, Department of Health Sciences
Kristianstad, 29188, Sweden
NCT Number: NCT02375750
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Kristianstad, 29188, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 6 months, 1 year
Time frame: 3 months,6months, 9 months,12months
Time frame: 3 months,6months, 9 months,12months
Time frame: 3 months,6months, 9 months,12months
Time frame: 12months
Geistlich Pharma AG
Industry
Surgical Treatment of Peri-implantitis Lesions, With or Without the Placement of a Bone Substitute and a Collagen Membrane. A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06083246
Mouth Diseases, Peri-Implantitis
Pavia, Lombardy, Italy
View Trial DetailsNCT05024760
Dental Implant Failed, Implant Infection
Tacoma, Washington, United States
View Trial DetailsNCT07700628
Mouth Diseases, Peri-Implantitis
Caserta, CE, Italy
View Trial DetailsNCT07678892
Mouth Diseases, Peri-Implantitis
Kristianstad, Sweden
View Trial Details