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NCT Number: NCT07124416

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

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.

Recruiting

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Key information

Conditions

Edentulous Alveolar Ridge

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Misi Si

CONTACT

[email protected]

+86 18605712858

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention: observational case-control study

Primary outcomes

  1. Width of Keratinized Mucosa, KMW

    Time frame: on the day of enrollment

  2. Plaque Index(PI)

    Time frame: on the day of enrollment

  3. Bleeding on Probing(BOP)

    Time frame: on the day of enrollment

  4. Peri-implant Probing Depth(PPD)

    Time frame: on the day of enrollment

  5. Marginal Bone Loss(MBL)

    Time frame: The X-ray examination will be completed on the day of enrollment

  6. Patient Satisfaction

    Time frame: on the day of enrollment

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

  7. Immunological parameters in peri-implant crevicular fluids(PICF)

    Time frame: The PICF will be collected on the day of enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Misi Si

CONTACT

[email protected]

+86 18605712858

Sponsors and collaborators

Lead sponsor

The Dental Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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