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

NCT07626866 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-06-04

No results posted yet for this study

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

Interventions

PROCEDURE

Free connective tissue graft without an epithelial collar

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.

PROCEDURE

Free connective tissue graft with epithelial collar

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.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Igor P Ashurko · I.M. Sechenov First Moscow State Medical University (Sechenov University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2026-06-20
Completion
2026-08-20

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 NCT07626866 on ClinicalTrials.gov