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Clinical Trials/NCT02896556
NCT02896556
Completed
Not Applicable

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

Hacettepe University1 site in 1 country33 target enrollmentAugust 31, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Demineralization
Sponsor
Hacettepe University
Enrollment
33
Locations
1
Primary Endpoint
Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 31, 2017
End Date
April 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zafer Cavit Cehreli, DDS, PhD

Professor

Hacettepe University

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months

Study Sites (1)

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