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

N/ANot Yet RecruitingNCT06166017

George Eastman Dental Hospital, Italy90 enrolled

Overview

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.

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

Conditions

Peri-Implantitis Peri-implant Mucositis Recession, Gingival

Interventions

Exposure to minimal amount of lingual keratinized tissue widthOTHER

measurement of clinical parameters

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: Day 1

Secondary Outcomes

Mucosal recession

Distance (mm) between the prosthetic margin/ locator and the mucosal margin

Time frame: Day 1

Bleeding on probing (BOP)

dichotomous measure of mucosal inflammation detected via periodontal probe

Time frame: Day 1

Probing pocket depth (PPD)

distance between the mucosal margin and the bottom of the sulcus/ pocket (mm)

Time frame: 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.

Time frame: Day 1

Crestal bone loss (mm)

Measured on radiograph (in mm) between the implant shoulder and the most coronal location of the crestal bone

Time frame: Day 1

Suppuration on probing

measured dichotomously (yes/no) when probing an implant

Time frame: Day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.