Evaluation of Esthetic Performance of Resin Infiltration... | NCT02896556

Studies
Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions

NCT02896556

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Jun 3, 2022Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Tooth Demineralization

Interventions

Resin infiltrate

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2017Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Aug 25, 2016

First Submission Date that Met QC Criteria

Sep 6, 2016

First Posted Date

Sep 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2022

Last Update Posted Date

Jun 3, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zafer Cavit Cehreli, DDS, PhD, Professor, Hacettepe UniversityPrincipal Investigator

Lead Sponsor

Hacettepe UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Resin infiltrate	Experimental	This is a single-arm study. Resin infiltration technique will be performed to all patients.	Device: Resin infiltrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resin infiltrate	Device	A resin that used for micro-invasive treatment of enamel-restricted, non-cavitated caries or hypo/demineralized smooth enamel surfaces.	Resin infiltrate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zafer C Cehreli, Prof	zcehreli@gmail.com	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University		Ankara		06100	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21401750	Background	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.
23810050	Background	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.

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases