A prospective, randomized controlled trial to evaluate correction of ridge contour deficiency using OSSIX® Volumax vs Fibro-Gide.

Datum Dental0 个研究点目标入组 65 人开始时间: 2022年10月18日最近更新: 2022年10月31日

适应症

试验速览

暂无简介。

•1. Males and females =18 years
•2. General good health (ASA 1 and ASA 2)
•3. Presence of a tissue contour deficiency leading to an unesthetic implant rehabilitation, not associated with bone dehiscence and/or fenestration defects.
•4. Patients require 1-3 implants placed between two periodontally stable natural teeth.
•5. Good oral hygiene (full mouth plaque index <25%)
•6. Adequate control of inflammation (full mouth bleeding on probing <25%)
•7. Patients that are willing to sign an informed consent and participate in the clinical study
•8. Patient that are able to understand and to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations

•1. Implant sites with associated alveolar bone dehiscence and/or fenestration defects that necessitate bone grafting in combination with correction of ridge contour deficiency.
•2. General contraindications for dental and/or surgical treatments
•3. Inflammatory and autoimmune disease of the oral cavity
•4. Allergy to collagen
•5. Uncontrolled diabetes (A1C > 6.5 %)
•6. Disease of oral mucosa
•7. Disease affecting connective tissue metabolism (e.g. collagenases)
•8. Uncontrolled Periodontal disease
•9. History of myeloma, respiratory tract cancer, breast cancer, prostate cancer, or kidney cancer requiring chemotherapy or radiotherapy.
•10. Concurrent or previous radiotherapy of head area
•11. Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy
•12. Heavy Smokers (over 10 cigarettes a day)
•13. Pregnant or lactating women.
•14. Women of childbearing age, who are not using a highly effective method of birth control
•15. Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to the study start.

发起方

Datum Dental