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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02896556
Enrollment
33
Registered
2016-09-12
Start date
2017-08-31
Completion date
2022-04-30
Last updated
2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Demineralization

Keywords

image analysis

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.

Interventions

DEVICEResin infiltrate

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

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry6 months

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026