An interventional study of Icon® resin infiltration and MI paste plus in White Spot Lesion, sponsored by Imam Abdulrahman Bin Faisal University. Status unknown at 1 site in Saudi Arabia. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Imam Abdulrahman Bin Faisal University · Not applicable, Interventional, and Treatment
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
Imam Abdulrahman Bin Faisal University is the lead sponsor of 88 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Icon® resin infiltration
Other: MI paste plus
Other: Icon® resin infiltration · Other: MI paste plus
low viscosity resin that can flow through the pores in the enamel surface
s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.
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
Time frame: Change from 0 day, 1 month and 6 months
Patient self satisfaction
Post-treatment patient satisfaction using the patient satisfaction scale
Time frame: Change from 0 day, 1 month and 6 months
Change in lesion status
Post-treatment change in caries lesion status using ICDAS II
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Change from 0 day, 1 month and 6 months
esthetic improvement
Esthetic improvement through objective assessments using a visual analogue
Time frame: Change from 0 day, 1 month and 6 months
Patient esthetic self perception
Pre-treatment esthetic self perception by the subjects using questionnaire
Time frame: Change from 0 day, 1 month and 6 months
change in lesion size
Pre-treatment and post-treatment white spot lesion size
Time frame: 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
Time frame: 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
Time frame: Change from 0 day, 1 month and 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Imam Abdulrahman Bin Faisal University