Assessing the Effects of Resin Infiltration and Resin Modified Glass Ionomer on the Color Changes of White Spot Lesions in a Clinical and Laboratory Setting

NCT06696105 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 140-07-23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to assess the efficacy of "Icon® resin infiltration" and "VanishTM XT varnish" in restoring the appearance of white spot lesions WSLs in healthy children affected with anterior white spot lesions. The main questions it aims to answer are: 1- Are Icon resin infiltration (RI) and Vanish™ XT varnish comparable in restoring esthetics of white spot lesions? Researchers will compare Resin infiltration to vanish xt varnish to see if they are effective in masking white spot lesions Participants will:

• Have their white spot lesions treated in the dental clinic by the intervention methods
• Visit the clinic after 1 month, 3 months and 6 months to assess the restorations objectively and subjectively

Conditions

White Spot Lesions; White Spot Lesions [Initial Caries] on Smooth Surface of Tooth; Enamel Hypomineralization

Keywords

"camouflage", "prevention", white spot lesion", "remineralization"

Outcome Measures

Primary Outcomes (1)

• color measurement

  The variance in the value of colors that are observed between two cohorts undergoing therapy, using vita shade spectrophotometer over a six-month period.

  6 months

Secondary Outcomes (1)

• color stability

  6 months

Study Arms (2)

Resin infiltration arm

EXPERIMENTAL

resin infiltration will be applied on white spot lesion of anterior teeth

Drug: Resin infiltration

vanish xt varnish arm

EXPERIMENTAL

vanish xt will be applied on white spot lesion of anterior teeth

Drug: Vanish XT varnish (resin modified glass ionomer restoration)

Interventions

Resin infiltration DRUG

"Icon® resin infiltration (DMG America, Englewood, NJ, US)" technique utilizes light-cured hydrophilic and low viscosity resins that can permeate WSL subsurface micropores. Resin modified glass ionomer cement includes Fluoroaluminosilicate glass, which facilitates the interaction of fluoride with the enamel surface resulting in an instant release . Concurrently, the predominant glass matrix serves as source of fluoride for the purpose of continuous release, hypothesized to facilitate remineralization.

Also known as: RI

Resin infiltration arm

Vanish XT varnish (resin modified glass ionomer restoration) DRUG

Resin modified glass ionomer cement includes Fluoroaluminosilicate glass, which facilitates the interaction of fluoride with the enamel surface resulting in an instant release. Concurrently, the predominant glass matrix serves as source of fluoride for the purpose of continuous release, hypothesized to facilitate remineralization.

Also known as: Vanish XT varnish

vanish xt varnish arm

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy children
• Presence of maxillary permanent anterior teeth with white spot lesions
• Vital pulp in the anterior teeth.

You may not qualify if:

• Any systemic or local conditions not permitting intervention
• Unwillingness to participate in the study
• Teeth with periodontal diseases, dental caries, direct or indirect restorations, yellow-brownish opacities with post eruptive enamel breakdown.

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (2)

King Abdulaziz University

Jeddah, Saudi Arabia, Saudi Arabia

Location

King Abdulaziz University

Jeddah, 23514, Saudi Arabia

Location

Related Publications (5)

• Al-Haj Ali SN, Alsulaim HN, Albarrak MI, Farah RI. Spectrophotometric comparison of color stability of microhybrid and nanocomposites following exposure to common soft drinks among adolescents: an in vitro study. Eur Arch Paediatr Dent. 2021 Aug;22(4):675-683. doi: 10.1007/s40368-021-00605-6. Epub 2021 Feb 10.

  PMID: 33566286 BACKGROUND

• Wiewiora C, Armbruster P, Lallier T, Ballard R. Effectiveness of Vanish XT in Reducing the Development of White Spot Lesions: An In Vitro Study. Oral Health Prev Dent. 2018;16(4):345-350. doi: 10.3290/j.ohpd.a40938.

  PMID: 30175332 BACKGROUND

• Kannan A, Padmanabhan S. Comparative evaluation of Icon(R) resin infiltration and Clinpro XT varnish on colour and fluorescence changes of white spot lesions: a randomized controlled trial. Prog Orthod. 2019 Jun 17;20(1):23. doi: 10.1186/s40510-019-0276-y.

  PMID: 31204437 BACKGROUND

• Giray FE, Durhan MA, Haznedaroglu E, Durmus B, Kalyoncu IO, Tanboga I. Resin infiltration technique and fluoride varnish on white spot lesions in children: Preliminary findings of a randomized clinical trial. Niger J Clin Pract. 2018 Dec;21(12):1564-1569. doi: 10.4103/njcp.njcp_209_18.

  PMID: 30560818 BACKGROUND

• Mehta A, Paramshivam G, Chugh VK, Singh S, Halkai S, Kumar S. Effect of light-curable fluoride varnish on enamel demineralization adjacent to orthodontic brackets: an in-vivo study. Am J Orthod Dentofacial Orthop. 2015 Nov;148(5):814-20. doi: 10.1016/j.ajodo.2015.05.022.

  PMID: 26522042 BACKGROUND

MeSH Terms

Conditions

Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Omar El-Meligy, MSc,Ph.D.

  King Abdulaziz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: the lesions will receive restorative minimally invasive treatment

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: August 20, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (2)