Using of Collagen Matrix for Maxillary Tuberosity Donor Area Preservation

NCT06039839 | Unknown

• 1 other identifier: AI-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

connective tissue graft; xenogeic collagen matrix; increasing of soft tissue thickness; dental implant; soft tissue augmentation; donor site

Outcome Measures

Primary Outcomes (1)

• Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting

  To carry out the measurement an optical impression will be taken using the Primescan intraoral scanner (Dentsply/SIRONA,Germany) before the operation and on the 90th day after the operation. Then, the stl files will be compared in the GOM Inspect software and the contour change will be evaluated at 3 equidistant points.

  [Day 90 compared to the 0th day (initial value)]

Secondary Outcomes (22)

• Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting

  [Day 180 compared to the 0th day (initial value)]

• Assessment of the severity of pain syndrome

  [4 hours compared to the 0th day (initial value)]

• Assessment of the severity of pain syndrome

  [day 1 compared to the 0th day (initial value)]

• Assessment of the severity of pain syndrome

  [day 3 compared to the 0th day (initial value)]

• Assessment of the severity of pain syndrome

  [day 5 compared to the 0th day (initial value)]

Study Arms (2)

first group

ACTIVE COMPARATOR

Healing of the donor area will be accomplished without the use of collagen matrix

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

second group

EXPERIMENTAL

Closure of the wound defect in the donor area in the region of the maxillary tuberosity will be carried out after CTG harvesting with the use of collagen matrix

Procedure: Closure of the donor area after CTG harvesting with collagen matrix

Interventions

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

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.

first group

Closure of the donor area after CTG harvesting with collagen matrix PROCEDURE

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

second group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of written informed consent of the patient to participate in the study;
• Age between 18 and 45 years;
• 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);
• Teeth without periodontal pathology, probing depth should not exceed 3 mm across the entire dentoalveolar sulcus;
• Satisfactory level of oral hygiene;
• Absence of general diseases in the stage of exacerbation or decompensation
• Patients who had previous harvesting of CTG from the same donor area;
• Patients with impacted third molars in the donor area;
• Presence of concomitant diseases in the stage of exacerbation or decompensation;
• Patients with oncological diseases, as well as patients who have received radiotherapy and chemotherapy in the last 5 years;
• Patients with a history of smoking for more than 10 years.

You may not qualify if:

• Patient refusal of further participation in the study;
• Pregnant and breastfeeding women;
• Patients with blood coagulation disorders (haemophilia, Willebrand's disease, intake of anticoagulants);
• Patients with diseases that impair soft tissue healing (insulin-dependent diabetes mellitus).

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, Russia

RECRUITING

Study Officials

• Igor Ashurko

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Ashurko

CONTACT

+7-926-515-05-55; ashurko_i_p@staff.sechenov.ru

Anna Galyas

CONTACT

+7-925-882-61-92; galyas_a_i@student.sechenov.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2023
• First Posted: September 15, 2023
• Study Start: January 17, 2023
• Primary Completion: December 30, 2024
• Study Completion: May 15, 2025
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)