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NCT Number: NCT07088172

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 grafts prior to the implantaion

Procedure

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

Primary outcomes

  1. Width of Keratinized Mucosa, KMW

    Time frame: Preoperative\Immediate postoperative\2 months postoperative\6 months postoperative

Secondary outcomes

  1. Thickness of Keratinized Mucosa, KMT

    Time frame: Preoperative\ Immediate postoperative\2 months postoperative\6 months postoperative

  2. Postoperative Discomfort

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

    Visual Analog Scale

  3. Plaque Index,PI

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

  4. Bleeding on Probing, BOP

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

  5. Peri-implant Probing Depth, PPD

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

  6. Marginal Bone Loss, MBL

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

  7. Patient Satisfaction

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

    Visual Analog Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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