Soft Tissue Augmentation Around Dental Implants

NCT07605286 | Completed

• 1 other identifier: 1/20
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in peri-implant soft tissue thickness from baseline to 6 months post-augmentation

  The primary outcome is the mean change in vertical soft tissue thickness at the implant site, measured at three equidistant points (crest, 1 mm apical, 2 mm apical) along the vestibular aspect of the alveolar ridge. Thickness is assessed using three complementary methods: (1) mucosal puncture with a calibrated spreader and silicone stopper under local anesthesia; (2) superimposition of cone-beam computed tomography (CBCT) scans; and (3) comparison of digital 3D intraoral scans (STL files) using GOM Inspect software. Measurements are averaged across the three points per site. The primary analysis compares mean thickness gain between the four intervention groups (palate CTG, tuberosity CTG, Fibro-Gide, FibroMatrix) at 6 months.

  Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery

Study Arms (4)

Palate CTG

EXPERIMENTAL

Subepithelial connective tissue graft harvested from the hard palate, placed at the implant site to augment soft tissue thickness and volume

Procedure: Connective Tissue Graft (Palate)

Tuberosity CTG

EXPERIMENTAL

Subepithelial connective tissue graft harvested from the maxillary tuberosity, placed at the implant site to augment soft tissue thickness and volume

Procedure: Connective Tissue Graft (Tuberosity)

Fibro-Gide

EXPERIMENTAL

Xenogeneic collagen matrix (porcine-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue

Device: Fibro-Gide Collagen Matrix

FibroMatrix

EXPERIMENTAL

Xenogeneic collagen matrix (bovine pericardium-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue

Device: FibroMatrix Collagen Matrix

Interventions

Connective Tissue Graft (Palate) PROCEDURE

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.

Palate CTG

Connective Tissue Graft (Tuberosity) PROCEDURE

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.

Tuberosity CTG

Fibro-Gide Collagen Matrix DEVICE

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.

Fibro-Gide

FibroMatrix Collagen Matrix DEVICE

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.

FibroMatrix

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 21 and 75 years
• Requirement for single dental implant placement in the mandibular molar region (replacing no more than one tooth)
• Need for soft tissue augmentation to achieve peri-implant mucosal thickness ≥2 mm
• Signed voluntary informed consent for treatment and research participation
• Ability and willingness to attend all scheduled follow-up examinations for 12 months post-surgery
• Adequate oral hygiene and commitment to maintain it throughout the study period

You may not qualify if:

• Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes, severe cardiovascular disease)
• Current or prior use of immunosuppressants, bisphosphonates, or high-dose corticosteroids
• History of cancer, radiation therapy, or chemotherapy within 5 years prior to enrollment
• Need for concurrent bone grafting or immediate implant placement following tooth extraction
• Active periodontal disease or untreated oral infections at the time of surgery
• Heavy smoking (\>10 cigarettes/day) or inability to abstain from smoking during the healing period
• Pregnancy or lactation
• Known allergy to collagen, porcine/bovine products, or materials used in the study (sutures, anesthetics)
• Participation in another clinical trial within 30 days prior to enrollment
• Refusal to participate in any stage of the study or inability to comply with study procedures
• Psychological or social conditions that, in the investigator's judgment, may compromise protocol adherence or data reliability

Sponsors & Collaborators

• Andrey Vasilyev: lead

Study Sites (1)

Central Research Institute of Dental and Maxillofacial Surgery

Moscow, 119021, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: leading researcher

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: October 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)