Randomized controlled clinical study to investigate effectiveness and safety of a Collagen Matrix 10808 for soft tissue volume augmentation after implant placement in single tooth gaps compared to autogenous connective tissue graft

Geistlich Pharma AG0 个研究点目标入组 20 人开始时间: 2012年3月2日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Inclusion criteria
•1. Implant placement at least 6 weeks and maximum 6 months prior enrolment
•2. Necessity of soft tissue augmentation in single tooth gap
•3. 2 teeth adjacent to each side of the defect have a mean BOP of < 30%
•4. Basic periodontal examination (BPE <2)
•5. 18 years or older
•6. Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
•7. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form

•Exclusion criteria
•1. Heavy smoker (> 10 cigarettes per day)
•2. Probing depth greater than 4 mm
•3. Insulin dependent diabetes
•4. General contraindications for dental and/or surgical treatment
•5. History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
•6. Women of child bearing age, not using a standard accepted method of birth control
•7. Pregnancy or breast feeding
•8. Previous and concurrent medication affecting mucosal healing in general (e.g.
•steroids, large doses of anti-inflammatory drugs)
•9. Disease affecting connective tissue metabolism (e.g. collagenases).
•10. Allergy to collagen
•11. Participation in a clinical trial within the last six months

发起方