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Comparative Analysis Using the Collagen Matrix and Autogenous Graft: Clinical Course, Aesthetic Results

NCT05870774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-09-26

No results posted yet for this study

Summary

This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 32 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 Fibro-Gide" (Geistlich Pharma AG, Bahnhofstrasse 40, 6110 Wolhusen, Switzerland; registration in Russia 19.08.2020 No FSZ -20207/11765). In the postoperative period the value of soft tissue thickness gain, severity of pain, collateral edema, amount of analgesics consumed, soft tissue aesthetics, keratinized mucosa width, quality of life and duration of surgery were assessed.

Conditions

  • Soft Tissue Atrophy

Interventions

PROCEDURE

Soft tissue augmentation with CTG

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Astra Tech dental implant (Dentsply, Germany) 3. Harvesting of free connective tissue graft from the maxilla tuberosity area 4. Fixation of the graft to the vestibular mucosal-periosteal flap 5. Suturing the wound tightly

PROCEDURE

Soft tissue augmentation with CM

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation 2. Placement of the Astra Tech dental implant (Dentsply, Germany) 3. Modeling of sterile collagen matrix according to the shape of the recipient bed 4. Fixation of the collagen matrix to the vestibular mucosal-periosteal flap 5. Suturing the wound tightly

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Igor Ashurko, ass.prof. · I.M. Sechenov First Moscow State Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2022-12-25
Completion
2023-05-18

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 NCT05870774 on ClinicalTrials.gov