NCT04994314

White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial

Effect of Calcium Fluoride Nanoparticles in Prevention of Demineralization During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the effectiveness of calcium fluoride nanoparticles containing orthodontic primer in preventing or decreasing the incidence WSLs over a period of 6 months in patients with fixed orthodontic appliances. This study proposed to be double blinded, split mouth, randomized clinical trial, with equal randomization (1:1 allocation ratio).

Detailed description

The sample was selected and recruited from patients attending two centres (Orthodontic Department at Karbala Governmental Specialized Dental Center and Almina Dental Private Clinics/Karbala), but the bonding and follow up sessions were done in Almina Dental Private Clinics/Karbala. Patient recruitment was done according to specified inclusion and exclusion criteria. Intervention procedure planned to be by bonding fixed orthodontic appliances to all patients. The four quadrants of the mouth will be divided into two groups (Group 1 and 2), with one group, the upper right and lower left quadrants bonded with nCaF2 resin, while the upper left and lower right quadrants bonded with control resin. For the other group, the reverse will be carried out. Then, by the use of a computer random number generator, the two groups will be randomly allocated, and each number in the random table will be given a study number in order to create the final Allocation Table for the participants in the study (which contained the study number and allocation group). the primary planned to be measured by DIAGNOdent Pen 2190 device to measure enamel demineralization objectively, while the secondary objective planned to be quantitative detection of Streptococcus mutans bacteria by using real-time PCR

Conditions

• White Spot Lesion of Tooth

Interventions

Type	Name	Description
DRUG	nCaF2 primer	Calcium fluoride nanoparticles was added to conventional orthodontic primers to develop bioactive primer. This primer was examined previously for its biological and physical properties
DRUG	Control primer	Conventional orthodontic primer

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-12-16
• Completion: 2022-02-15
• First posted: 2021-08-06
• Last updated: 2021-08-06

Locations

1 site across 1 country: Iraq