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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorThe Dental Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention: observational case-control study

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: inadequate keratinized mucosa0 interventions
Group B: adequate keratinized mucosa1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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