Soft Tissue Augmentation Around Dental Implants

Summary

The goal of this study is to determine which method better increases the volume of soft tissues (gums) around dental implants: using the patient's own tissues or applying collagen matrices. The study also evaluates the safety of these methods and their impact on smile aesthetics.

The main questions it aims to answer:

Which method provides greater and more stable increase in gum thickness around the implant? Does the choice of material affect gum color (how well it matches adjacent areas)? What features of healing and cellular tissue structure are observed when using different materials?

Researchers will compare:

Autogenous connective tissue grafts (CTG) - the patient's own connective tissue grafts harvested from the palate or maxillary tuberosity Xenogeneic collagen matrices (XCM) - bioresorbable materials of animal origin (Fibro-Gide® and FibroMatrix®) that do not require harvesting the patient's own tissue

Participants will:

Undergo a surgical procedure to increase soft tissue volume in the area of implant placement (using one of four methods assigned randomly)

Attend clinic visits for follow-up examinations and assessments:

* Before surgery
* 3 months after surgery
* 6 months after surgery

Undergo additional examinations:

* 3D intraoral scanning to assess changes in tissue volume
* Cone-beam computed tomography (CBCT) to measure gum thickness
* Polarized-light photography to evaluate gum color
* Collection of a small tissue sample (biopsy) for laboratory analysis of tissue structure and cellular composition

Conditions

• Peri-implant Soft Tissue Augmentation
• Dental Implant Rehabilitation

Interventions

DEVICE

Fibro-Gide Collagen Matrix

Porcine-derived xenogeneic collagen matrix (types I/III), 6 mm thick, gamma-sterilized. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required.

PROCEDURE

Connective Tissue Graft (Palate)

Autogenous subepithelial connective tissue graft harvested from the hard palate (premolar-molar region) using a horizontal incision 2-3 mm apical to the gingival margin. Epithelium removed microscopically. Graft secured within a soft-tissue "envelope" at the recipient implant site using U-shaped sutures. Donor site closed with compression sutures.

PROCEDURE

Connective Tissue Graft (Tuberosity)

Autogenous subepithelial connective tissue graft harvested from the maxillary tuberosity using parallel incisions 2 mm distal to the last molar. Epithelial strip removed. Graft placed and secured at the implant site using U-shaped suturing technique. Donor site closed with interrupted sutures.

DEVICE

FibroMatrix Collagen Matrix

Bovine pericardium-derived xenogeneic collagen matrix (types I/III), 3-4 mm thick, freeze-dried, bilayer structure. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required.

Sponsors & Collaborators

• Andrey Vasilyev

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2024-10-01

Completion

2024-10-01

Countries

• Russia

Study Locations