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

The Dental Hospital of Zhejiang University School of Medicine

Status: Enrolling

Conditions: Edentulous Alveolar Ridge In Mandible

Treatments: Procedure: free gingival grafts prior to the implantaion; Procedure: free gingival grafts during the second stage of implant surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07088172

2024-064

Details and patient eligibility

About

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.

Full description

To compare the clinical outcomes and the differences in hard and soft tissue stability at implant sites with insufficient buccal keratinized gingiva in the mandibular posterior region, where free gingival grafts are applied either before implant surgery or concurrently during the second stage of implant surgery.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

free gingival grafting during the second stage of implant surgery

Experimental group

Description:

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

Treatment:

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

free gingival grafts prior to the implantation

Other group

Description:

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

Treatment:

Procedure: free gingival grafts prior to the implantaion