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| Name | Class |
|---|---|
| Jordan University of Science and Technology | OTHER |
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Fluoride varnish is being applied on the teeth surfaces of patients undergoing orthodontic treatment just before receiving their clear aligners. The effect of the varnish was investigated if it can reduce the incidence of enamel demineralization or not.
Background: The preventive effect of fluoride varnish on the development of white spot lesions (WSLs) during clear aligner treatment has not been investigated in the literature. Hence this was the purpose of this study. Material and Methods: This was a prospective double-blinded randomized clinical trial. A total of 44 patients (7 males, 37 females, with a mean age of 20.91 ± 4.56) who sought clear aligner therapy at the postgraduate orthodontic clinics at JUST were recruited and randomly divided equally (n=22 in each group) by a website randomizer. Eligibility criteria included healthy patients of both sexes (age range 14-30 years), Class I malocclusion with mild-to-moderate crowding (≤5 mm), non-extraction treatment plan, and optimum oral hygiene before treatment. Both the patient and the investigator were blinded during the intervention and assessment of outcomes. At (T0) Fluoride varnish was applied to the subjects in Group 1, while normal saline was applied to the subjects in Group 2 as a control. Quantitative light-induced fluorescence (QLF) images were taken at the start of the treatment (T0) and after 4 months (T1). The QLF images were analyzed to assess the primary outcomes: lesion area (Pixels), the mean amount of fluorescence loss (ΔF)% in addition to the number of newly developed lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoride varnish group | Experimental | Patients received a layer of fluoride varnish on their teeth before the start of orthodontic clear aligner therapy |
|
| Control group | Placebo Comparator | Patients received a layer of normal saline on their teeth before the start of orthodontic clear aligner therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride varnsh | Other | Fluoride varnish was applied to the teeth surfaces before aligner therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average lesion fluorescence loss (∆F%) | It reflects amount of mineral loss | 4 months |
| Maximum lesion fluorescence loss (∆F-max%) | It measures the deepest point of the lesion (in relation to sound enamel) using QLF system in percent | 4 months |
| Lesion area | It measures white spot lesion area in pixels | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque measurement | It measures the amount of plaque on teeth surfaces in percent using QLF system | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Al-Khateeb | Jordan University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Teaching Clinics/JUST | Irbid | 22110 | Jordan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25532098 | Background | Zabokova-Bilbilova E, Popovska L, Kapusevska B, Stefanovska E. White spot lesions: prevention and management during the orthodontic treatment. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2014;35(2):161-8. doi: 10.2478/prilozi-2014-0021. | |
| 2640705 | Background | Ogaard B. [Cariologic aspects of orthodontic treatment]. Nor Tannlaegeforen Tid. 1989 Dec;99(20):802-5. Norwegian. |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Double blinded randomized controlled clinical trial
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Nor the subjects neither the investigator knew the type of varnish they received. Additionally, the outcome assessor was blinded before making the analysis
| Normal saline | Other | Normal saline was applied to the teeth surfaces before aligner therapy |
|
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