Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions

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

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Key information

Conditions

Tooth Demineralization Stomatognathic Diseases Tooth Diseases

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resin infiltrate

Device

A resin that used for micro-invasive treatment of enamel-restricted, non-cavitated caries or hypo/demineralized smooth enamel surfaces.

Primary outcomes

Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2022
First posted: Sep 12, 2016
Registry last updated: Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed