Clinical Trials Directory

Trials / Completed

CompletedNCT02896556

Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
7 Years – 17 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

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

Timeline

Start date
2017-08-31
Primary completion
2021-12-01
Completion
2022-04-30
First posted
2016-09-12
Last updated
2022-06-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT02896556. Inclusion in this directory is not an endorsement.