Clinical Effects of Keratinized Mucosa Augmentation Around Dental Implant With Free Gingival Graft in Different Surgical Timing at Mandibular Posterior Sites

NCT07088172 | Recruiting DMC

• 1 other identifier: 2024-064
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare clinical outcomes and tissue stability at implant sites in the mandibular posterior region with insufficient buccal keratinized gingiva. It will assess the use of free gingival grafts either before or during the second stage of implant surgery.

Conditions

Edentulous Alveolar Ridge In Mandible

Outcome Measures

Primary Outcomes (1)

• Width of Keratinized Mucosa, KMW

  Preoperative\Immediate postoperative\2 months postoperative\6 months postoperative

Secondary Outcomes (7)

• Thickness of Keratinized Mucosa, KMT

  Preoperative\ Immediate postoperative\2 months postoperative\6 months postoperative

• Postoperative Discomfort

  follow-up time point(at least 6 months after restoration)

• Plaque Index,PI

  follow-up time point(at least 6 months after restoration)

• Bleeding on Probing, BOP

  follow-up time point(at least 6 months after restoration)

• Peri-implant Probing Depth, PPD

  follow-up time point(at least 6 months after restoration)

Study Arms (2)

free gingival grafting during the second stage of implant surgery

EXPERIMENTAL

Free gingival graft surgery performed simultaneously with the second stage of the implant surgery, followed by the restoration 6-8 weeks later.

Procedure: free gingival grafts during the second stage of implant surgery

free gingival grafts prior to the implantation

OTHER

Free gingival graft surgery is performed 6-8 weeks before implant placement

Procedure: free gingival grafts prior to the implantaion

Interventions

free gingival grafts during the second stage of implant surgery PROCEDURE

Free gingival graft surgery performed simultaneously with implant stage II, followed by upper restoration 6-8 weeks later.

free gingival grafting during the second stage of implant surgery

free gingival grafts prior to the implantaion PROCEDURE

Free gingival graft surgery performed 6-8 weeks before implant placement

free gingival grafts prior to the implantation

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, gender unrestricted;
• partially edentulous in the mandible posterior area, planned for implant-supported fixed restoration;
• Buccal keratinized mucosa width at the implant site is less than 2mm, with the transplantation area not exceeding 2 teeth;
• No soft tissue augmentation performed at the site prior to surgery;
• Overall health is good, with no systemic diseases that may affect bone metabolism or wound healing;
• Good periodontal condition, no progressive alveolar bone resorption, no periodontal abscess;
• Smoking ≤ 10 cigarettes per day.

You may not qualify if:

• Uncontrolled metabolic diseases;
• Severe periodontal disease, with unstable periodontal condition;
• Smoking \> 10 cigarettes per day;
• Unwilling to participate in the follow-up of this study;
• Other conditions that do not meet the requirements for implant treatment.

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Central Study Contacts

Misi Si

CONTACT

+86 18605712858; misi_si@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: May 23, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

CN (1)