Evaluation of Esthetic Performance of Resin Infiltration Technique on Enamel Lesions

NCT02896556 | Completed

• 1 other identifier: HUDHF-2-Icon
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Conditions

Tooth Demineralization

Keywords

image analysis

Outcome Measures

Primary Outcomes (1)

• Esthetic success of resin-infiltration technique after 6 months as assessed by spectrophotometry

  6 months

Study Arms (1)

Resin infiltrate

EXPERIMENTAL

This is a single-arm study. Resin infiltration technique will be performed to all patients.

Device: Resin infiltrate

Interventions

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

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 21401750 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.

  PMID: 23810050 BACKGROUND

• 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.

  PMID: 23989837 BACKGROUND

MeSH Terms

Conditions

Tooth Demineralization

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Zafer C Cehreli, Prof

  zcehreli@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 12, 2016
• Study Start: August 31, 2017
• Primary Completion: December 1, 2021
• Study Completion: April 30, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

TU (1)