Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions
Primary Purpose
Tooth Demineralization
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Resin infiltrate
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Demineralization focused on measuring image analysis
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
Sites / Locations
- Hacettepe University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resin infiltrate
Arm Description
This is a single-arm study. Resin infiltration technique will be performed to all patients.
Outcomes
Primary Outcome Measures
Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02896556
Brief Title
Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions
Official Title
Evaluation of Esthetic Performance of Resin Infiltration Technique on Hypomineralized and Demineralized Enamel Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Demineralization
Keywords
image analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resin infiltrate
Arm Type
Experimental
Arm Description
This is a single-arm study. Resin infiltration technique will be performed to all patients.
Intervention Type
Device
Intervention Name(s)
Resin infiltrate
Intervention Description
A resin that used for micro-invasive treatment of enamel-restricted, non-cavitated caries or hypo/demineralized smooth enamel surfaces.
Primary Outcome Measure Information:
Title
Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zafer C Cehreli, Prof
Organizational Affiliation
zcehreli@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21401750
Citation
Kim S, Kim EY, Jeong TS, Kim JW. The evaluation of resin infiltration for masking labial enamel white spot lesions. Int J Paediatr Dent. 2011 Jul;21(4):241-8. doi: 10.1111/j.1365-263X.2011.01126.x. Epub 2011 Mar 14.
Results Reference
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PubMed Identifier
23810050
Citation
Knosel M, Eckstein A, Helms HJ. Durability of esthetic improvement following Icon resin infiltration of multibracket-induced white spot lesions compared with no therapy over 6 months: a single-center, split-mouth, randomized clinical trial. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):86-96. doi: 10.1016/j.ajodo.2013.02.029.
Results Reference
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PubMed Identifier
23989837
Citation
Senestraro SV, Crowe JJ, Wang M, Vo A, Huang G, Ferracane J, Covell DA Jr. Minimally invasive resin infiltration of arrested white-spot lesions: a randomized clinical trial. J Am Dent Assoc. 2013 Sep;144(9):997-1005. doi: 10.14219/jada.archive.2013.0225.
Results Reference
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Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions
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