NCT06039839

Using of Collagen Matrix for Maxillary Tuberosity Donor Area Preservation

Use of a Double-layered Collagen Matrix for Preservation of the Maxillary Tuberosity Area Upon Free Connective Tissue Graft Harvesting

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: I.M. Sechenov First Moscow State Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of this study is to perform a comparative analysis of the effectiveness of using a double-layer collagen matrix to preserve the parameters of the donor area in the region of the maxillary tuberosity versus healing of the wound surface without its use. Examination and treatment of patients will be carried out on the basis of the Department of Surgical Dentistry of the E.V. Borovsky Institute of Dentistry of I.M. Sechenov First Moscow State Medical University. The object of the study will be patients with an inclusion defect on the maxilla or mandible within 1-2 teeth combined with a soft tissue thickness deficiency in the area of dental implants (\< 2 mm) which requires mucosal augmentation operation. All patients will be randomly divided into two groups depending on the surgical procedure. In 1 group (n=15) the donor area will heal by secondary tension, and in 2 group (n=15) the collagen matrix "FibroMATRIX" will be used to close the wound defect in the donor area. The groups will be comparable in terms of gender and age characteristics. The randomisation of patients will be performed at the stage of surgical intervention as follows: after taking a free connective tissue graft and adapting the CTG to the recipient bed, an envelope with a randomly assigned method of donor area closure will be opened. Patients in both groups will undergo dental implantation according to the standard protocol and healing abutment installation. In both groups of patients, a free connective tissue graft will be taken from the maxillary tuberosity and the autograft will be fixed to the vestibular full-thickness muco-periosteal flap with horizontal U-shaped sutures, followed by wound closure using simple interrupted sutures without tension. Further, the collagen matrix "FibroMATRIX" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671) will be adapted to the donor area for the patients of the 2 group, the patients of both groups will have to perform suturing of the wound surface using simple interrupted sutures. In the postoperative period, standard antibacterial and anti-inflammatory therapy should be administered in combination with the use of topical antiseptics for daily care.

Conditions

• Soft Tissue Atrophy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-17
• Primary completion: 2024-12-30
• Completion: 2025-05-15
• First posted: 2023-09-15
• Last updated: 2023-09-15

Locations

1 site across 1 country: Russia