Actively Recruiting
The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
Led by The Dental Hospital of Zhejiang University School of Medicine · Updated on 2025-08-15
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how the presence of keratinized mucosa, the firm gum tissue around dental implants, affects the health of the soft and hard tissues near the implant site. The study compares clinical signs, patient-reported experiences, and levels of inflammation between implant areas with adequate keratinized mucosa (2 mm or more) and those with inadequate tissue (less than 2 mm). This observational study aims to understand the impact of gum tissue quality on implant health. Participants in this study have already received dental implant restorations, either single crowns or fixed bridges, and are grouped based on the width of their keratinized mucosa around the implant. There is no treatment given as part of the study; it is observational. The study collects data at one point in time, focusing on implant sites with either less than 2 mm or at least 2 mm of keratinized mucosa. During the enrollment visit, researchers will measure gum tissue width, plaque levels, bleeding on probing, probing depth around the implant, and bone loss using X-rays. They will also collect fluid from around the implant to analyze inflammatory markers and assess patient satisfaction. Participants will only have this single study visit, and the study is expected to end in December 2026.
CONDITIONS
Brief Title
The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 to 70 years (inclusive of 18 and 70 years), of any gender
- Patients who have undergone dental implant restoration (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
You will not qualify if you...
- Patients who are unwilling to participate in the follow-up of this study for various reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo assessments including measurement of keratinized mucosa width, plaque index, bleeding on probing, probing depth, marginal bone loss via X-ray, patient satisfaction surveys, and collection of immunological samples.
1 visit (in-person)
Duration - Up to the study completion date in December 2026
Participants with different keratinized mucosa widths are observed without intervention to assess peri-implant tissue health over time.
No scheduled visits; participants are observed as part of routine care
Trial Site Locations
Total: 1 location
1
The Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
M
Misi Si
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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