Timing of free gingival grafts to increase gum tissue around lower back dental implants
Clinical Effects of Keratinized Mucosa Augmentation Around Dental Implant With Free Gingival Graft in Different Surgical Timing at Mandibular Posterior Sites
This trial will test whether placing a free gingival graft before implants or during the second-stage surgery gives better gum tissue width and stability for adults getting implants in the lower back jaw with less than 2 mm of keratinized gum.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Dental Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07088172 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two surgical timings for free gingival grafting at mandibular posterior implant sites with insufficient buccal keratinized mucosa. One group receives the graft before implant placement and the other receives it during the second-stage implant surgery. Clinical measurements of soft- and hard-tissue stability, keratinized mucosa width, and related outcomes will be recorded over follow-up visits. Eligible patients are adults with partially edentulous mandibular posterior sites planned for implant-supported fixed restorations and buccal keratinized mucosa under 2 mm.
Who should consider this trial
Good fit: Adults (≥18 years) with partial tooth loss in the lower back jaw who plan implant-supported fixed restorations and have less than 2 mm of buccal keratinized mucosa, good overall and periodontal health, and smoke no more than 10 cigarettes per day are ideal candidates.
Not a fit: Patients with uncontrolled metabolic disease, severe or unstable periodontal disease, heavy smokers (>10 cigarettes/day), or those needing augmentation over more than two teeth are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the procedure timing that provides better gum stability could improve long-term implant health, comfort, and ease of oral hygiene for patients.
How similar studies have performed: Free gingival grafting is an established method to increase keratinized mucosa and has shown clinical success, though direct comparisons of graft timing (before versus during second-stage surgery) are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- The Stomatology Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Misi Si
- Email: misi_si@zju.edu.cn
- Phone: +86 18605712858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.