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

Not yet recruiting

• Conditions: Peri-implant Mucositis; Recession, Gingival; Peri-Implantitis
• Interventions: Other: Exposure to minimal amount of lingual keratinized tissue width

• Registration Number: NCT06166017
• Lead Sponsor: George Eastman Dental Hospital, Italy

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-11-22
• Study First Submitted QC: 2023-12-10
• Study First Posted: 2023-12-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22
• Study Start: 2024-04
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Full-arch implant-supported restorations for fully edentulous patients	Exposure to minimal amount of lingual keratinized tissue width	No interventions will be administered. Instead, clinical parameters will be collected (see detailed description) as well as radiographs of the implants.

Primary Outcome Measures

Name	Time	Method
Diagnosis of peri-implantitis (composite outcome made of different outcomes): yes or no (dichotomous)	Day 1	dichotomous (yes or no) outcome composed by PPD (mm), BoP/SOP (yes or no dichotomous) and bone loss (mm, assessed on radiograph)

Secondary Outcome Measures

Name	Time	Method
Suppuration on probing	Day 1	measured dichotomously (yes/no) when probing an implant
Bleeding on probing (BOP)	Day 1	dichotomous measure of mucosal inflammation detected via periodontal probe
Probing pocket depth (PPD)	Day 1	distance between the mucosal margin and the bottom of the sulcus/ pocket (mm)
Crestal bone loss (mm)	Day 1	Measured on radiograph (in mm) between the implant shoulder and the most coronal location of the crestal bone
Mucosal recession	Day 1	Distance (mm) between the prosthetic margin/ locator and the mucosal margin
Self-assessed Brushing discomfort	Day 1	Rated by patient on Visual analog score (100 mm) to define the amount of discomfort during brushing, with 0 being the minimum and 100 being maximum discomfort. The patient will be asked to rate their level of discomfort by placing an X over the line. The distance from 0 to the X will be measured and converted into a percentage of the entire length of the line.
Diagnosis of mucositis	Day 1	dichotomous (yes/no) presence of mucosal peri-implant inflammation in the absence of crestal bone loss