Does having at least 2 mm of keratinized gum tissue affect implant health and patient comfort?
The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
This project will see if having at least 2 mm of keratinized gum around dental implants affects peri-implant tissue health, local inflammation, and patient-reported outcomes in adults treated at Zhejiang University's dental hospital at least six months after restoration.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The Dental Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07124416 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional observational comparison of implant sites with adequate (≥2 mm) versus inadequate (<2 mm) keratinized mucosa. Clinicians will collect clinical indices, patient-reported outcome measures, and levels of inflammatory markers from peri-implant gingival crevicular fluid. Participants are adults 18–70 who received single-crown or fixed-bridge restorations at The Stomatology Hospital, Zhejiang University School of Medicine at least six months prior. Data will be compared between the two groups to explore associations between keratinized mucosa width and peri-implant soft and hard tissue health.
Who should consider this trial
Good fit: Adults aged 18–70 who had single-crown or fixed-bridge implant restorations at The Stomatology Hospital, Zhejiang University School of Medicine at least six months earlier and who consent to study exams are ideal candidates.
Not a fit: People without implants placed at that hospital, those less than six months after their final restoration, or those unwilling to participate are unlikely to gain benefit from participating.
Why it matters
Potential benefit: If results show a clear relationship, clinicians could use keratinized mucosa status to guide decisions about preserving or augmenting gum tissue to improve implant outcomes and patient comfort.
How similar studies have performed: Prior observational studies have reported mixed but generally supportive findings that ≥2 mm of keratinized mucosa is associated with better peri-implant soft tissue health and patient comfort, though results are not uniformly conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals aged 18 to 70 years (inclusive of 18 and 70 years), of any gender; * Patients who have undergone dental implant restoration是（single crown or fixed bridge restorations） at the Stomatology Hospital, Zhejiang University School of medicine and have had their final restoration for at least 6 months; * Patients who voluntarily participate and sign the informed consent form after being fully informed, and who cooperate with relevant examinations. Exclusion Criteria: * Patients who are unwilling to participate in the follow-up of this study for various reasons
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.