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

Not Applicable

• Conditions: White Spot Lesion
• Interventions: Other: MI paste plus; Other: Icon® resin infiltration

• Registration Number: NCT04673097
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-10
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-12
• Last Update Submitted: 2020-12-12
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17
• Study Start: 2020-12-19
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2	MI paste plus	-
Group 3	Icon® resin infiltration	-
Group 1	Icon® resin infiltration	-
Group 3	MI paste plus	-

Primary Outcome Measures

Name	Time	Method
fracture of enamel.	Change from 0 day, 1 month and 6 months	Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM
Color improvements	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	Change from 0 day, 1 month and 6 months	Post-treatment patient satisfaction using the patient satisfaction scale
Change in lesion status	Change from 0 day, 1 month and 6 months	Post-treatment change in caries lesion status using ICDAS II
Cracks of enamel.	Change from 0 day, 1 month and 6 months	Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM
Microbial composition.	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	Change from 0 day, 1 month and 6 months	Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument.
Effects on clinical parameter: prolonged response to hot or cold.	Change from 0 day, 1 month and 6 months	Pre-treatment and post-treatment effects on response to hot or cold by cold test
esthetic improvement	Change from 0 day, 1 month and 6 months	Esthetic improvement through objective assessments using a visual analogue
Patient esthetic self perception	Change from 0 day, 1 month and 6 months	Pre-treatment esthetic self perception by the subjects using questionnaire
change in lesion size	Change from 0 day, 1 month and 6 months	Pre-treatment and post-treatment white spot lesion size

Trial Locations

Locations (1)

Imam Abdulrahman Bin Faisal University; 🇸🇦 Dammam, Saudi Arabia