Using of Collagen Matrix for Maxillary Tuberosity Donor Area Preservation (NCT06039839) | Clinical Trial Compass
UnknownNot Applicable
Using of Collagen Matrix for Maxillary Tuberosity Donor Area Preservation
Russia30 participantsStarted 2023-01-17
Plain-language summary
An interventional prospective randomised clinical trial (RCT) in parallel groups is planned. The sample size was 30 patients who will be randomly divided into two groups based on the surgical procedure. The first group is the healing of the donor zone after SCTG harvesting without filling the wound with collagen matrix. The second group is the wound defect closure in the donor area using the collagen matrix "FibroMATRIX" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting, severity of pain, postoperative edema, bleeding, analgesic intake and quality of life in the postoperative period will be assessed.
Who can participate
Age range18 Years ā 45 Years
SexALL
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Inclusion criteria
ā. Presence of written informed consent of the patient to participate in the study;
ā. Age between 18 and 45 years;
ā. Included defects on the maxilla or mandible within 1-2 teeth combined with soft tissue thickness deficiency in the area of dental implants (\< 2 mm);
ā. Teeth without periodontal pathology, probing depth should not exceed 3 mm across the entire dentoalveolar sulcus;
ā. Satisfactory level of oral hygiene;
ā. Absence of general diseases in the stage of exacerbation or decompensation
ā. Patients who had previous harvesting of CTG from the same donor area;
ā. Patients with impacted third molars in the donor area;
Exclusion criteria
ā. Patient refusal of further participation in the study;
ā
What they're measuring
1
Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting
Timeframe: [Day 90 compared to the 0th day (initial value)]
Trial details
NCT IDNCT06039839
SponsorI.M. Sechenov First Moscow State Medical University