The Dental Hospital of Zhejiang University School of Medicine
Phase
Observational
Started
2025-07-10
Last updated
2025-08-15
Condition(s) studied
Edentulous Alveolar Ridge
Investigational drug(s) / intervention(s)
No intervention
No intervention: No intervention: observational case-control study
Study summary
This study aims to conduct a cross-sectional study to compare the differences in clinical indices, patient-reported outcomes, and levels of inflammatory factors in peri-implant gingival crevicular fluid between sites with adequate (≥ 2 mm) and inadequate (\< 2 mm) keratinized mucosa after implant restoration, in order to explore the impact of the presence of keratinized mucosa on peri-implant soft and hard tissue health.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Width of Keratinized Mucosa, KMW — on the day of enrollment
Plaque Index(PI) — on the day of enrollment
Bleeding on Probing(BOP) — on the day of enrollment
Peri-implant Probing Depth(PPD) — on the day of enrollment
Marginal Bone Loss(MBL) — The X-ray examination will be completed on the day of enrollment
Patient Satisfaction — on the day of enrollment visual analogue scale \[VAS\] 0-10,e.g., not at all satisfied to perfectly satisfied
Immunological parameters in peri-implant crevicular fluids(PICF) — The PICF will be collected on the day of enrollment PICF samples were collected from buccal aspects of implants after removing all supragingival plaque. The levels of IL-1β and PGE2 in PICF were measured using a sandwich ELISA kit.
Trial sites (1)
Facility
City
Region
Status
The Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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