A Phase 3 interventional study of nCaF2 primer and Control primer in White Spot Lesion of Tooth, sponsored by University of Baghdad. Status unknown at 1 site in Iraq. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by University of Baghdad · Phase 3, Interventional, and Prevention
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).
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
University of Baghdad is the lead sponsor of 164 studies on the registry; 66 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients have
Exclusion Criteria:
Patients will be excluded if they had
Fixed appliance for ten maxillary teeth and the contralateral mandibular teeth will be bonded using orthodontic primer containing calcium fluoride nanoparticles
Drug: nCaF2 primer
Fixed appliance for ten maxillary teeth (contralateral to experimental ten side)and the contralateral mandibular teeth will be bonded using conventional primer (TransbondTM XT orthodontic primers (3M-Unitek, Monrovia, USA)
Drug: Control 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
Also known as: Orthodontic primer containing calcium fluoride nanoparticles
Conventional orthodontic primer
Also known as: TransbondTM XT orthodontic primer
DIAGNOdent Pen scores change
assessing changes in the amount of enamel demineralization (DIAGNOdent Pen scores) between four time points:- 1. baseline (before brackets bonding) 2. after one month of brackets bonding 3. after three months of brackets bonding 4. after six months of brackets bonding
Time frame: Six months
Streptococcus mutans load change
Quantitative detection of streptococcus mutans load changes (using real time PCR) between four time points:- 1. baseline (before brackets bonding) 2. after one month of brackets bonding 3. after three months of brackets bonding 4. after six months of brackets bonding
Time frame: Six months
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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University of Baghdad