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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07124416
Enrollment
150
Registered
2025-08-15
Start date
2025-07-10
Completion date
2026-12-31
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Alveolar Ridge

Brief 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.

Interventions

OTHERNo intervention

No intervention: observational case-control study

Sponsors

The Dental Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Width of Keratinized Mucosa, KMWon 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 Satisfactionon the day of enrollmentvisual 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 enrollmentPICF 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.

Countries

China

Contacts

Primary ContactMisi Si
misi_si@zju.edu.cn+86 18605712858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026