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

NCT ID: NCT07088172

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-23

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Edentulous Alveolar Ridge In Mandible

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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free gingival grafting during the second stage of implant surgery

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

Group Type EXPERIMENTAL

free gingival grafts during the second stage of implant surgery

Intervention Type PROCEDURE

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

free gingival grafts prior to the implantation

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

Group Type OTHER

free gingival grafts prior to the implantaion

Intervention Type PROCEDURE

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

Interventions

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free gingival grafts during the second stage of implant surgery

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

Intervention Type PROCEDURE

free gingival grafts prior to the implantaion

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Dental Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Misi Si

Role: CONTACT

+86 18605712858

Facility Contacts

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Misi Si

Role: primary

+86 18605712858

Other Identifiers

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2024-064

Identifier Type: -

Identifier Source: org_study_id

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