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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| orthodontic primer containing calcium fluoride nanoparticles | Active Comparator | Fixed appliance for ten maxillary teeth and the contralateral mandibular teeth will be bonded using orthodontic primer containing calcium fluoride nanoparticles |
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| Control primer | Placebo Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nCaF2 primer | Drug | Calcium fluoride nanoparticles was added to conventional orthodontic primers to develop bioactive primer. This primer was examined previously for its biological and physical properties |
| Measure | Description | Time Frame |
|---|---|---|
| DIAGNOdent Pen scores change | assessing changes in the amount of enamel demineralization (DIAGNOdent Pen scores) between four time points:-
| Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Streptococcus mutans load change | Quantitative detection of streptococcus mutans load changes (using real time PCR) between four time points:-
| Six months |
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Inclusion Criteria:
Patients have
Exclusion Criteria:
Patients will be excluded if they had
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rawof R. Al Tuma, MSc | Contact | +9647901762894 | raooftoma@yahoo.com | |
| Yassir A. Yassir, PhD | Contact | +9647703919599 | yassirkyassir@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yassir A. Yassir, PhD | Baghdad University- College of Dentistry | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almina dental clinics | Recruiting | Karbala | 56001 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36049047 | Derived | Al Tuma RR, Yassir YA. Effect of calcium fluoride nanoparticles in prevention of demineralization during orthodontic fixed appliance treatment: a randomized clinical trial. Eur J Orthod. 2023 Mar 31;45(2):122-132. doi: 10.1093/ejo/cjac055. |
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The study planned to be split mouth study with equal randomization (1:1 allocation ratio)
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This study proposed to be double blinded (the patients, investigators and the outcome assessors)
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| Control primer | Drug | Conventional orthodontic primer |
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