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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Other: Exposure to minimal amount of lingual keratinized tissue width


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Full-arch implant-supported restorations for fully edentulous patients<br>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<br>* measurement of clinical parameters<br>|

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 |