Randomized controlled clinical multi-center 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 88 人开始时间: 2014年3月3日最近更新: 2024年8月19日

适应症

试验速览

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•Inclusion Criteria
•1. 18 years or older
•2. Ability to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
•3. Ability to fully understand the nature of the proposed surgery and ability to sign the informed consent form
•4. Necessity of soft tissue augmentation in a single tooth gap
•5. Implant placement at least 6 weeks prior baseline examination
•6. One tooth adjacent to each side of the defect with a mean BOP of < 20%
•7. Basic periodontal examination (BPE) <2

•Exclusion criteria
•1.Presence of a bony dehiscence >3 mm at the implant site assessed at the time of surgery (soft tissue augmentation)
•2.Heavy smoker (> 10 cigarettes per day)
•3.Presence of periodontal disease
•4.Insulin dependent diabetes
•5.General contraindications for dental and/or surgical treatment
•6.History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
•7.Women of child bearing age, not using a highly effective method of birth control
•8.Pregnancy or breast feeding
•9.Previous and concurrent medication affecting mucosal healing in general
•(e.g. topical steroids, large doses of anti-inflammatory drugs)
•10.Disease affecting connective tissue metabolism
•11.Any systemic diseases that contraindicate implant placement
•12.Allergy to collagen
•13.Participation in an investigational device or drug clinical trial within the last six months

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