The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Edentulous Alveolar Ridge. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other No intervention
No intervention: observational case-control study
Primary outcome measures
- Width of Keratinized Mucosa, KMW [Time frame: on the day of enrollment]
- Plaque Index(PI) [Time frame: on the day of enrollment]
- Bleeding on Probing(BOP) [Time frame: on the day of enrollment]
- Peri-implant Probing Depth(PPD) [Time frame: on the day of enrollment]
- Marginal Bone Loss(MBL) [Time frame: The X-ray examination will be completed on the day of enrollment]
- Patient Satisfaction [Time frame: on the day of enrollment]
- Immunological parameters in peri-implant crevicular fluids(PICF) [Time frame: The PICF will be collected on the day of enrollment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- The Stomatology Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07124416 · 2025-104