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

White Spot Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04673097
• Other study ID #: IAU_resin
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 19, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2020
• Source: Imam Abdulrahman Bin Faisal University
• Contact: jumanah aljishi
• Phone: 00966534282332
• Email: jumanah.aljishi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion

Intervention

Other:
• Icon® resin infiltration
low viscosity resin that can flow through the pores in the enamel surface
• 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.

Locations

Country	Name	City	State
Saudi Arabia	Imam Abdulrahman Bin Faisal University	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient self satisfaction	Post-treatment patient satisfaction using the patient satisfaction scale	Change from 0 day, 1 month and 6 months
Primary	Change in lesion status	Post-treatment change in caries lesion status using ICDAS II	Change from 0 day, 1 month and 6 months
Primary	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
Primary	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
Primary	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
Primary	esthetic improvement	Esthetic improvement through objective assessments using a visual analogue	Change from 0 day, 1 month and 6 months
Primary	Patient esthetic self perception	Pre-treatment esthetic self perception by the subjects using questionnaire	Change from 0 day, 1 month and 6 months
Primary	change in lesion size	Pre-treatment and post-treatment white spot lesion size	Change from 0 day, 1 month and 6 months
Primary	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
Primary	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