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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-Implantitis; Peri-implant Mucositis; Recession, Gingival
• Intervention / Treatment: Other: Exposure to minimal amount of lingual keratinized tissue width

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 Type: Observational
• Enrollment (Estimated): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; measurement of clinical parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal recession	Distance (mm) between the prosthetic margin/ locator and the mucosal margin	Day 1
Bleeding on probing (BOP)	dichotomous measure of mucosal inflammation detected via periodontal probe	Day 1
Probing pocket depth (PPD)	distance between the mucosal margin and the bottom of the sulcus/ pocket (mm)	Day 1
Self-assessed Brushing discomfort	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.	Day 1
Crestal bone loss (mm)	Measured on radiograph (in mm) between the implant shoulder and the most coronal location of the crestal bone	Day 1
Suppuration on probing	measured dichotomously (yes/no) when probing an implant	Day 1
Diagnosis of mucositis	dichotomous (yes/no) presence of mucosal peri-implant inflammation in the absence of crestal bone loss	Day 1

Collaborators and Investigators

• Sponsor: George Eastman Dental Hospital, Italy

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 10, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession; Mucositis; Peri-Implantitis
• Other Study ID Numbers: GeorgeEastmanDH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No