Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic R… (NCT05870774) | Clinical Trial Compass
CompletedNot Applicable
Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic Results
Russia52 participantsStarted 2021-10-28
Plain-language summary
This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 32 patients who were randomly divided into two groups depending on the surgical intervention used. First group - patients underwent increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the upper jaw. Second group - patients used collagen matrix Fibro-Gide" (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ -20207/11765). In the postoperative period the value of soft tissue thickness gain, severity of pain, collateral edema, amount of analgesics consumed, soft tissue aesthetics, keratinized mucosa width, quality of life and duration of surgery were assessed.
Who can participate
Age range25 Years – 59 Years
SexALL
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Inclusion criteria
✓. The presence of written informed consent of the patient to participate in the study;
✓. Age from 25 to 59 years;
✓. The presence of an included defect in the distal part of the lower jaw with a sufficient volume of bone tissue;
✓. Soft tissue thickness \<3 mm on the vestibular side;
✓. Adjacent teeth without periodontal pathology, the depth of probing should not exceed 3 mm along the entire dentoalveolar furrow;
✓. Satisfactory level of oral hygiene;
✓. Patients without concomitant pathology or with concomitant pathology in the compensation stage.
✓. Age less than 25 and more than 59 years;
Exclusion criteria
✕. Patients with infections either periodontally or periapically, which developed after inclusion in the study;
✕
What they're measuring
1
The amount of soft tissue thickness gain
Timeframe: [Day 90 compared to the 0th day (initial value)]
Trial details
NCT IDNCT05870774
SponsorI.M. Sechenov First Moscow State Medical University