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

NCT06166017 | Not Yet Recruiting DMC

• 1 other identifier: GeorgeEastmanDH
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peri-Implantitis; Peri-implant Mucositis; Recession, Gingival

Outcome Measures

Primary Outcomes (1)

• Diagnosis of peri-implantitis (composite outcome made of different outcomes): yes or no (dichotomous)

  dichotomous (yes or no) outcome composed by PPD (mm), BoP/SOP (yes or no dichotomous) and bone loss (mm, assessed on radiograph)

  Day 1

Secondary Outcomes (7)

• Mucosal recession

  Day 1

• Bleeding on probing (BOP)

  Day 1

• Probing pocket depth (PPD)

  Day 1

• Self-assessed Brushing discomfort

  Day 1

• Crestal bone loss (mm)

  Day 1

Study Arms (1)

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.

Other: Exposure to minimal amount of lingual keratinized tissue width

Interventions

Exposure to minimal amount of lingual keratinized tissue width OTHER

measurement of clinical parameters

Full-arch implant-supported restorations for fully edentulous patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Volunteers presenting with integrated implants supporting a fixed or removable full-arch prosthesis. Minimum loading time of 12 months.

You may qualify if:

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

You may not qualify if:

• Implants loaded less than 12 months before examination
• Mobile (non integrated) implants
• Partially edentulous patients

Sponsors & Collaborators

• George Eastman Dental Hospital, Italy: lead

MeSH Terms

Conditions

Peri-Implantitis; Gingival Recession

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Atrophy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty, Senior Researcher, Clinical Professor

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 12, 2023
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share