Health TrialsbyHealthPanel

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

ConditionEdentulous Alveolar Ridge In Mandible
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Dental Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • free gingival grafts during the second stage of implant surgery

    Procedure/Surgery

    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/Surgery

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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: free gingival grafting during the second stage of implant surgeryExperimental treatment 1 intervention
Group B: free gingival grafts prior to the implantationOther 1 intervention

Trial outcomes

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

Visual Analog Scale

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Dental Hospital of Zhejiang University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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