Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar

NCT07626866 | Active Not Recruiting

• 1 other identifier: AI-05
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized interventional clinical trial (RCT) with a parallel-group design is planned. The study sample will include 32 patients randomly allocated into two groups according to the surgical intervention performed. In the first group, a free connective tissue graft with an epithelial collar will be used. In the second group, a free connective tissue graft without an epithelial collar will be used. In the postoperative period, assessment of changes in the width of keratinized mucosa, soft tissue thickness, pain severity, postoperative swelling, and patient quality of life will be performed.

Conditions

Soft Tissue Atrophy

Keywords

Connective tissue graft; increasing of soft tissue thickness; dental implant; soft tissue augmentation

Outcome Measures

Primary Outcomes (1)

• Change in the Width of Keratinized Mucosa

  Measurements will be performed using optical impressions obtained with the Primescan intraoral scanner (Dentsply/Sirona) or conventional impressions followed by digital scanning before surgery and on postoperative day 90. Subsequently, STL files will be superimposed using GOM Inspect software, and contour changes will be assessed at three equidistant points.

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

Secondary Outcomes (24)

• Change in the Width of Keratinized Mucosa

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

• Assessment of Scar Formation According to the Modified Scar Index (MSI)

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

• Assessment of Scar Formation According to the Modified Scar Index (MSI)

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

• Assessment of Pain Severity

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

• Assessment of Pain Severity

  Day 1 compared to the 0th day (initial value)

Study Arms (2)

first group

ACTIVE COMPARATOR

Patients will receive a free connective tissue graft without an epithelial collar

Procedure: Free connective tissue graft without an epithelial collar

second group

EXPERIMENTAL

Patients will receive a free connective tissue graft with epithelial collar

Procedure: Free connective tissue graft with epithelial collar

Interventions

Free connective tissue graft without an epithelial collar PROCEDURE

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol. 2. Formation of the recipient site in the vestibular area. 3. Harvesting of free connective tissue graft from the maxilla tuberosity area or palate and its adaptation to the recipient site. 4. Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area. 5. Suturing of the wound in the donor site.

first group

Free connective tissue graft with epithelial collar PROCEDURE

1. Incision the mucosa at the alveolar ridge, mucosal-periosteal flap elevation, preparation of the implant bed and placement of the dental implant according to the standard protocol. 2. Formation of the recipient site in the vestibular area. 3. Harvesting of free connective tissue graft with epithelial strip from the maxilla tuberosity area or palate and its adaptation to the recipient site. 4. Fixation of the graft to the vestibular mucosal-periosteal flap and tight suturing of the wound in the recipient area. 5. Suturing of the wound in the donor site.

second group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who previously underwent connective tissue graft harvesting from the same donor site;
• Patients with impacted third molars in the donor site area;
• Presence of concomitant diseases in the stage of exacerbation or decompensation;
• Patients with malignant neoplasms, as well as patients who underwent radiation therapy or chemotherapy within the previous 5 years;
• Patients with a smoking history of more than 10 years.

You may not qualify if:

• Patient refusal to continue participation in the study;
• Pregnant or breastfeeding women;
• Patients with coagulation disorders (hemophilia, von Willebrand disease, or anticoagulant therapy);
• Patients with diseases affecting soft tissue healing processes (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

Location

Study Officials

• Igor P Ashurko

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

  PRINCIPAL INVESTIGATOR

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: May 29, 2026
• First Posted: June 4, 2026
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)