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

NCT07124416 | Recruiting DMC

• 1 other identifier: 2025-104
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Alveolar Ridge

Outcome Measures

Primary Outcomes (7)

• Width of Keratinized Mucosa, KMW

  on 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 Satisfaction

  visual analogue scale \[VAS\] 0-10,e.g., not at all satisfied to perfectly satisfied

  on the day of enrollment

• Immunological parameters in peri-implant crevicular fluids(PICF)

  PICF 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.

  The PICF will be collected on the day of enrollment

Study Arms (2)

inadequate keratinized mucosa

peri-implant width of keratinized mucosa less than 2 mm

adequate keratinized mucosa

peri-implant width of keratinized mucosa ≥ 2 mm

Other: No intervention

Interventions

No intervention OTHER

No intervention: observational case-control study

adequate keratinized mucosa

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have completed dental implant restoration（single crown or fixed bridge restorations） for at least 6 months and undergo routine follow-up examinations.

You may qualify if:

• 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.

You may not qualify if:

• Patients who are unwilling to participate in the follow-up of this study for various reasons

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Central Study Contacts

Misi Si

CONTACT

+86 18605712858; misi_si@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: August 15, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (1)