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Clinical Trials/NCT07088172
NCT07088172RecruitingNot Applicable

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 Medicine1 site in 1 country24 target enrollmentStarted: May 23, 2024Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
Width of Keratinized Mucosa, KMW
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Width of Keratinized Mucosa, KMW

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

Secondary Outcomes

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

Investigators

Sponsor
The Dental Hospital of Zhejiang University School of Medicine
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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