White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial
Sponsored by University of Baghdad
About this trial
Last updated 4 years ago
Study ID
calcium fluoride nanoparticles
Status
Unknown status
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
All
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 3 years ago
What is this trial about?
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).
What are the participation requirements?
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) .
Locations
Location
Status
Recruiting