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Using of Collagen Matrix for Maxillary Tuberosity Donor Area Preservation

NCT06039839 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-15

No results posted yet for this study

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.

Conditions

  • Soft Tissue Atrophy

Interventions

PROCEDURE

Closure of the donor area after CTG harvesting without the use of collagen matrix

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, placement of the dental implant 2. Harvesting of free connective tissue graft from the maxilla tuberosity area and it's fixation to the vestibular mucosal-periosteal flap, tight suturing of the wound in the recipient area 3. Suturing of the wound in the donor site.

PROCEDURE

Closure of the donor area after CTG harvesting with collagen matrix

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, placement of the dental implant 2. Harvesting of free connective tissue graft from the maxilla tuberosity area and it's fixation to the vestibular mucosal-periosteal flap, tight suturing of the wound in the recipient area 3. Adaptation of sterile collagen matrix to the donor site 4. Suturing of the wound in the donor site

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Igor Ashurko · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-17
Primary Completion
2024-12-30
Completion
2025-05-15

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039839 on ClinicalTrials.gov