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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
Sponsor:
Information provided by (Responsible Party):
Zafer Cavit Cehreli, DDS, PhD, Hacettepe University

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

Condition or disease Intervention/treatment Phase
Tooth Demineralization Device: Resin infiltrate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Zafer C Cehreli, Prof 00905353197969 zcehreli@gmail.com
Contact: Beste Ozgur, Research as. 00905052657769 besteisbitiren@yahoo.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey, 06100
Contact: Zafer C Cehreli, DDS, PhD    +903123052289    zcehreli@gmail.com   
Contact: Gizem Erbas Unverdi, DDS, PhD    +903123052280    erbasgizem@yahoo.com   
Principal Investigator: Zafer C Cehreli, Prof         
Sub-Investigator: Gizem Erbas Unverdi, Research as.         
Sub-Investigator: Beste Ozgur, Research as.         
Sub-Investigator: Atilla Ertan, Prof         
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Zafer C Cehreli, Prof zcehreli@gmail.com
Publications:
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Responsible Party: Zafer Cavit Cehreli, DDS, PhD, Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT02896556    
Other Study ID Numbers: HUDHF-2-Icon
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zafer Cavit Cehreli, DDS, PhD, Hacettepe University:
image analysis
Additional relevant MeSH terms:
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Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases