Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the esthetic performance of resin infiltration technique on superficial hypo-mineralized and demineralized enamel lesions of anterior teeth

Detailed Description
-----------------
The teeth that meet the inclusion criteria will be cleaned from debris and clinical intra-oral photos of the lesions will be taken before and after the treatment. Resin infiltration technique will be performed according to manufacturer's instructions under rubber-dam isolation. Intra-oral photos will be taken directly after infiltration (1 day), and 1 week and 6 months later. The system of the Commission Internationale de l'Eclairage (CIE) involving 3 color parameters: lightness (L), red/ green chromaticity (a), and yellow/blue chromaticity (b), will be used to assess the extent and durability of color and lightness changes between lesion and sound enamel areas before and after resin infiltration. The extent of assimilation and durability of effect will be assessed by comparing CIE L*a*b data collected before infiltration (baseline), directly after infiltration (1 day), and 1 week and 6 months later. The color assessments were standardized using a spectrophotometer (SpectroShade, Italy). Lesion areas will be measured for each time point by using an image analysis toolkit (ImageJ, National Institutes of Health, Bethesda, Md.). Multifactorial analysis of variance with repeated measures will be used for statistical analyses.

Official Title
-----------------
Evaluation of Esthetic Performance of Resin Infiltration Technique on Hypomineralized and Demineralized Enamel Lesions

Conditions
-----------------
Tooth Demineralization

Intervention / Treatment
-----------------
* Device: Resin infiltrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients and parents of patients who accept to participate and sign the informed consent. At least one non-cavitated anterior teeth with a superficial discoloration on enamel due to demineralization or hypo mineralization Fully erupted anterior teeth with closed apices. Exclusion Criteria: Patients and parents of patients who accept to participate. Teeth having absence of active cavitated-caries lesions, root canal treatment or restorations Teeth with ICDAS code 3 lesions (localized enamel breakdown due to caries with no visible dentin) Teeth that have a previously esthetic procedure (e.g. bleaching) Patients who are not in cooperation with the procedure. Fully erupted teeth with open apices

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resin infiltrate<br>This is a single-arm study. Resin infiltration technique will be performed to all patients. | Device: Resin infiltrate<br>* A resin that used for micro-invasive treatment of enamel-restricted, non-cavitated caries or hypo/demineralized smooth enamel surfaces.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
image analysis