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

Study Overview
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Brief Summary
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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

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

Conditions
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White Spot Lesion

Intervention / Treatment
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* Other: Icon® resin infiltration
* Other: MI paste plus


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Other: Icon® resin infiltration<br>* low viscosity resin that can flow through the pores in the enamel surface<br>|
| Active Comparator: Group 2<br> | Other: MI paste plus<br>* s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.<br>|
| Active Comparator: Group 3<br> | Other: Icon® resin infiltration<br>* low viscosity resin that can flow through the pores in the enamel surface<br>Other: MI paste plus<br>* s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color improvements | Pre-treatment and post-treatment color changing (L*A*B values) of digital photographs using the Commission Internationale de l'Eclairage (CIE) system | Change from 0 day, 1 month and 6 months | 
| Patient self satisfaction | Post-treatment patient satisfaction using the patient satisfaction scale | Change from 0 day, 1 month and 6 months | 
| Change in lesion status | Post-treatment change in caries lesion status using ICDAS II | Change from 0 day, 1 month and 6 months | 
| Cracks of enamel. | Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM | Change from 0 day, 1 month and 6 months | 
| Microbial composition. | 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. | Change from 0 day, 1 month and 6 months | 
| Effects on clinical parameter: sensitivity to percussion | Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument. | Change from 0 day, 1 month and 6 months | 
| esthetic improvement | Esthetic improvement through objective assessments using a visual analogue | Change from 0 day, 1 month and 6 months | 
| Patient esthetic self perception | Pre-treatment esthetic self perception by the subjects using questionnaire | Change from 0 day, 1 month and 6 months | 
| change in lesion size | Pre-treatment and post-treatment white spot lesion size | Change from 0 day, 1 month and 6 months | 
| fracture of enamel. | Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM | Change from 0 day, 1 month and 6 months | 
| Effects on clinical parameter: prolonged response to hot or cold. | Pre-treatment and post-treatment effects on response to hot or cold by cold test | Change from 0 day, 1 month and 6 months |