Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments

Overview

The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: November 30, 2022

Interventions

  • Other: Icon® resin infiltration
    • low viscosity resin that can flow through the pores in the enamel surface
  • Other: MI paste plus
    • s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.

Arms, Groups and Cohorts

  • Experimental: Group 1
  • Active Comparator: Group 2
  • Active Comparator: Group 3

Clinical Trial Outcome Measures

Primary Measures

  • Color improvements
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Pre-treatment and post-treatment color changing (L*A*B values) of digital photographs using the Commission Internationale de l’Eclairage (CIE) system
  • Patient self satisfaction
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Post-treatment patient satisfaction using the patient satisfaction scale
  • Change in lesion status
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Post-treatment change in caries lesion status using ICDAS II
  • Cracks of enamel.
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM
  • Microbial composition.
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Pre-treatment and post-treatment microbial composition of plaque samples. Samples will be stored at -80 °C until DNA extractions will be performed and run the 16S rRNA sequencing.
  • Effects on clinical parameter: sensitivity to percussion
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument.
  • esthetic improvement
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Esthetic improvement through objective assessments using a visual analogue
  • Patient esthetic self perception
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Pre-treatment esthetic self perception by the subjects using questionnaire
  • change in lesion size
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Pre-treatment and post-treatment white spot lesion size
  • fracture of enamel.
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM
  • Effects on clinical parameter: prolonged response to hot or cold.
    • Time Frame: Change from 0 day, 1 month and 6 months
    • Pre-treatment and post-treatment effects on response to hot or cold by cold test

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who are willing and able to observe good oral hygiene and attend for the study visits. – Subjects with ≥1 visible and accessible early caries lesion present. – No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste. Exclusion Criteria:

  • Active carious lesions – Facial surface restorations – Deciduous teeth – Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia) – Intrinsic and extrinsic strains – Physically and mentally challenged volunteers – Patients with systemic diseases under medication – Smokers

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Imam Abdulrahman Bin Faisal University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jumanah Aljishi, Dental intern – Imam Abdulrahman Bin Faisal University
  • Overall Contact(s)
    • jumanah aljishi, 00966534282332, jumanah.aljishi@gmail.com

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