Lingual Keratinized Tissue in Fully Edentulous Patients and Its Impact on Implant Health

NCT ID: NCT06166017

Last Updated: 2024-02-22

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

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-01-31

Brief Summary

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Cross-sectional study involving the measurement of the width of lingual keratinized tissue (in the implant locations) in fully edentulous patients restored with dental implants. The width of KT will be correlated with the primary outcome, diagnosis of peri-implantitis, defined as Probing depth (PPD)\>= 6 mm, inflammation/ bleeding on probing (BOP) and bone loss \>= 3 mm from the implant platform.

Detailed Description

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The study will be conducted with a cross-sectional design. All clinical parameters (width of buccal and lingual keratinized tissue, probing depth, bleeding on probing, plaque, crestal bone loss, gingival index, suppuration) will be collected in mandibular implants in fully edentulous lower arches. The width of lingual band of keratinized tissue (KT) will be be correlated with diagnosis of peri-implantitis or peri-implant mucositis.

Conditions

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Peri-Implantitis Peri-implant Mucositis Recession, Gingival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Full-arch implant-supported restorations for fully edentulous patients

No interventions will be administered. Instead, clinical parameters will be collected (see detailed description) as well as radiographs of the implants.

Exposure to minimal amount of lingual keratinized tissue width

Intervention Type OTHER

measurement of clinical parameters

Interventions

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Exposure to minimal amount of lingual keratinized tissue width

measurement of clinical parameters

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Osseointegrated (non-mobile) and loaded dental implant
* Mandibular implants
* Full-arch implant-supported prostheses
* Removable full-arch prostheses
* Fixed full-arch prostheses

Exclusion Criteria

* Implants loaded less than 12 months before examination
* Mobile (non integrated) implants
* Partially edentulous patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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George Eastman Dental Hospital, Italy

OTHER

Sponsor Role lead

Responsible Party

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Lucrezia Paternò Holtzman

Faculty, Senior Researcher, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GeorgeEastmanDH

Identifier Type: -

Identifier Source: org_study_id

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