The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-report… (NCT07124416) | Clinical Trial Compass
RecruitingNot Applicable
The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
China150 participantsStarted 2025-07-10
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Width of Keratinized Mucosa, KMW
Timeframe: on the day of enrollment
2
Plaque Index(PI)
Timeframe: on the day of enrollment
3
Bleeding on Probing(BOP)
Timeframe: on the day of enrollment
4
Peri-implant Probing Depth(PPD)
Timeframe: on the day of enrollment
5
Marginal Bone Loss(MBL)
Timeframe: The X-ray examination will be completed on the day of enrollment
6
Patient Satisfaction
Timeframe: on the day of enrollment
7
Immunological parameters in peri-implant crevicular fluids(PICF)
Timeframe: The PICF will be collected on the day of enrollment
Trial details
NCT IDNCT07124416
SponsorThe Dental Hospital of Zhejiang University School of Medicine