The Impact of the Adequacy of Keratinized Mucosa on Peri-implant Tissue Health and Patient-reported Outcomes

NCT ID: NCT07124416

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-10

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Edentulous Alveolar Ridge

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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inadequate keratinized mucosa

peri-implant width of keratinized mucosa less than 2 mm

No interventions assigned to this group

adequate keratinized mucosa

peri-implant width of keratinized mucosa ≥ 2 mm

No intervention

Intervention Type OTHER

No intervention: observational case-control study

Interventions

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No intervention

No intervention: observational case-control study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Dental Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Misi Si

Role: CONTACT

+86 18605712858

Facility Contacts

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Misi Si

Role: primary

+86 18605712858

Other Identifiers

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2025-104

Identifier Type: -

Identifier Source: org_study_id

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