Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04994314
Other study ID # calcium fluoride nanoparticles
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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) .

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03004196 - Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans Phase 1/Phase 2
Terminated NCT04827966 - Remineralization Agents for the Treatment of White Spot Lesions N/A
Not yet recruiting NCT03973554 - Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions Phase 2
Completed NCT05757440 - Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions N/A
Completed NCT05871619 - Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions N/A
Not yet recruiting NCT03930927 - Effect of Self Assembling Peptide on White Spot Lesion Early Phase 1
Not yet recruiting NCT03721198 - RMGI Varnish Versus APF Gel in Prevention of White Spot Lesions During Orthodontic Treatment N/A
Completed NCT03526276 - Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth N/A
Recruiting NCT03823612 - Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions Phase 4
Recruiting NCT05206539 - Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children Phase 3
Completed NCT04401280 - Bioactive Glass in the Treatment of Enamel White Spot Lesions Phase 3
Completed NCT03738839 - A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence Method N/A
Completed NCT04992481 - Fluoride Varnish, Ozone, Octenidin and WSLs in Orthodontic Patients N/A
Active, not recruiting NCT05764187 - Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets N/A
Recruiting NCT03217084 - Treatment of Postorthodontic White Spot Lesions Phase 4
Recruiting NCT06402500 - Color Masking Potential of Bioactive and ICON Materials N/A