Clinical and Histological Outcomes of Using Collagen Matrix or Soft Tissue Graft Around Implants (NCT05123898) | Clinical Trial Compass
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Clinical and Histological Outcomes of Using Collagen Matrix or Soft Tissue Graft Around Implants
Russia30 participantsStarted 2020-01-14
Plain-language summary
This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 35 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 "Fibromatrix" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). In the postoperative period the value of soft tissue thickness gain, duration of surgery, severity of pain syndrome and quality of life were assessed. Also, after 3 months simultaneously with installation of gingiva formers biopsy specimens were sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. The presence of written informed consent of the patient to participate in the study;
✓. The presence of an included defect (1 teeth) in the distal part of the lower jaw with a sufficient volume of bone tissue;
✓. Deficiency of soft tissue thickness;
✓. Adjacent teeth are without any of periodontal disease, namely the absence of periodontal probing depth \> 3 mm in any site of adjacent teeth;
✓. The presence of concomitant pathology in the stage of decompensation;
✓. Hard smokers (more than 10 cigarettes per day);
✓. Radio and chemotherapy in history over the past 5 years;
✓. Pregnancy and breastfeeding;
Exclusion criteria
✕. Patients with infections either periodontally or periapically;
✕. Pregnantcy following entrance into the study;
What they're measuring
1
The amount of soft tissue thickness gain
Timeframe: Days 90
Trial details
NCT IDNCT05123898
SponsorI.M. Sechenov First Moscow State Medical University