Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions
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|ClinicalTrials.gov Identifier: NCT02896556|
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : March 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tooth Demineralization||Device: Resin infiltrate||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Esthetic Performance of Resin Infiltration Technique on Hypomineralized and Demineralized Enamel Lesions|
|Actual Study Start Date :||August 31, 2017|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2022|
Experimental: Resin infiltrate
This is a single-arm study. Resin infiltration technique will be performed to all patients.
Device: Resin infiltrate
A resin that used for micro-invasive treatment of enamel-restricted, non-cavitated caries or hypo/demineralized smooth enamel surfaces.
- Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896556
|Contact: Zafer C Cehreli, Profemail@example.com|
|Contact: Beste Ozgur, Research firstname.lastname@example.org|
|Ankara, Turkey, 06100|
|Contact: Zafer C Cehreli, DDS, PhD +903123052289 email@example.com|
|Contact: Gizem Erbas Unverdi, DDS, PhD +903123052280 firstname.lastname@example.org|
|Principal Investigator: Zafer C Cehreli, Prof|
|Sub-Investigator: Gizem Erbas Unverdi, Research as.|
|Sub-Investigator: Beste Ozgur, Research as.|
|Sub-Investigator: Atilla Ertan, Prof|
|Principal Investigator:||Zafer C Cehreli, Profemail@example.com|