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

White Spot Lesion of Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994314
• Other study ID #: calcium fluoride nanoparticles
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: August 2021
• Source: University of Baghdad
• Contact: Rawof R. Al Tuma, MSc
• Phone: +9647901762894
• Email: raooftoma[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: February 15, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients have

1. Fully erupted permanent teeth (regardless the third molar),

2. Indication to have orthodontic treatment without extraction

3. Fair or good oral hygiene before or after oral hygiene instruction

Exclusion Criteria:

• Patients will be excluded if they had

1. Previous orthodontic treatment or extractions

2. Missing teeth

3. Active enamel caries determined by clinical examination

4. Patients with enamel hypoplasia, dental fluorosis or tetracycline pigmentation

5. Labial restorations

6. Severe periodontal diseases determined according to PDI index by Sigurd P. Ramfjord (Ramfjord, 1967)

7. Craniofacial syndromes such as clefts

8. Xerostomia determined from clinical history of the patient

9. Severely rotated teeth (limiting the appearance of buccal surfaces)

10. Heavy smokers determined by accounting the number of cigarettes per day and time to the first cigarette of the day (Heatherton et al., 1989) .

Related Conditions & MeSH terms

• White Spot Lesion of Tooth

Intervention

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
• Control primer
Conventional orthodontic primer

Locations

Country	Name	City	State
Iraq	Almina dental clinics	Karbala

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DIAGNOdent Pen scores change	assessing changes in the amount of enamel demineralization (DIAGNOdent Pen scores) between four time points:-; baseline (before brackets bonding); after one month of brackets bonding; after three months of brackets bonding; after six months of brackets bonding	Six months
Secondary	Streptococcus mutans load change	Quantitative detection of streptococcus mutans load changes (using real time PCR) between four time points:-; baseline (before brackets bonding); after one month of brackets bonding; after three months of brackets bonding; after six months of brackets bonding	Six months