Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Evaluation of Direct Composite Veneer Restorations

NCT05842590

Molar Incisor Hypomineralization

UNKNOWN NA

Clinical Performance of Injectable Composite Resins in Class I Cavities

NCT06192667

Caries,Dental

ACTIVE_NOT_RECRUITING NA

CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL

NCT05559333

Class I Dental Caries

COMPLETED NA

Clinical Performance of a Highly-filled Flowable Composite in Class III Restorations.

NCT07051551

Dental Caries

ACTIVE_NOT_RECRUITING NA

Clinical Evaluation of Posterior Indirect Adhesive Restorations

NCT04293770

Dental Caries Endodontically Treated Teeth Dental Restoration Failure of Marginal Integrity +2 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Demineralization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resin infiltrate

This is a single-arm study. Resin infiltration technique will be performed to all patients.

Group Type EXPERIMENTAL

Resin infiltrate

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resin infiltrate

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes