Status:
COMPLETED
A Randomized Controlled Clinical Trial to Evaluate Safety and Effectiveness of CAF + Mucograft® Compared to CAF Alone in Patients With Gingival Recessions
Lead Sponsor:
Geistlich Pharma AG
Conditions:
Gingival Recession
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this multi-center study is to determine the efficacy and safety of Mucograft® in combination with the coronally advanced flap (CAF) for the treatment of gingival recessions. It is assum...
Detailed Description
Primary goals of mucogingival surgery have changed with time from maintaining gingival health and prevent further progression of the recession to providing predictable root coverage solving patients' ...
Eligibility Criteria
Inclusion
- The patient (male or female) must be 18 years or older
- The patient must be a candidate for bilateral root coverage procedure
- Recession defects are Miller Class I-II and do not vary more than 2 mm.
- At least one mm keratinized tissue is present.
- Patient shows sufficient plaque control (FMPS \< 20%).
- If patient is of child-bearing potential, the patient confirms not to be pregnant and agrees to take contraception for at least 6 months after surgery.
- The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent.
Exclusion
- Patient is a heavy smoker (\> 10 cigarettes per day)
- Patient is an insulin dependent diabetic
- General contraindications for dental and/or surgical treatment are present.
- The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
- The patient is pregnant or nursing
- The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
- The patient has a disease, which affects connective tissue metabolism (e.g. collagenases).
- The patient is allergic to collagen.
- Patients have participated in a clinical trial within the last six months.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00902876
Start Date
March 1 2009
End Date
January 1 2012
Last Update
February 8 2019
Active Locations (1)
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1
Prof. Mariano Sanz
Madrid, Spain, 2804