Clinical trial NCT02896556: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Demineralization
Keywords: image analysis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 33
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: zcehreli@gmail.com
name: Zafer C Cehreli, Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.