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Recruiting NCT07088172

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

No phase Interventional Edentulous Alveolar Ridge In Mandible

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: free gingival grafts during the second stage of implant surgery, free gingival grafts prior to the implantaion.
Who it may be relevant to
Registry conditions: Edentulous Alveolar Ridge In Mandible. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

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.

Interventions

  • Procedure 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.
  • Procedure free gingival grafts prior to the implantaion
    Free gingival graft surgery performed 6-8 weeks before implant placement

Primary outcome measures

  • Width of Keratinized Mucosa, KMW [Time frame: Preoperative\Immediate postoperative\2 months postoperative\6 months postoperative]
Secondary outcome measures (7)
  • Thickness of Keratinized Mucosa, KMT [Time frame: Preoperative\ Immediate postoperative\2 months postoperative\6 months postoperative]
  • Postoperative Discomfort [Time frame: follow-up time point(at least 6 months after restoration)]
  • Plaque Index,PI [Time frame: follow-up time point(at least 6 months after restoration)]
  • Bleeding on Probing, BOP [Time frame: follow-up time point(at least 6 months after restoration)]
  • Peri-implant Probing Depth, PPD [Time frame: follow-up time point(at least 6 months after restoration)]
  • Marginal Bone Loss, MBL [Time frame: follow-up time point(at least 6 months after restoration)]
  • Patient Satisfaction [Time frame: follow-up time point(at least 6 months after restoration)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Stomatology Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07088172 · 2024-064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗