Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment

White Spot Lesion Clinical Trial

Official title:

Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment With QLF Compared to Conventional Fixed Appliances: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107012
• Other study ID #: JUST20160295
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2019
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF)

Description:

White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners, however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one group using clear aligners and one group wearing fixed orthodontic appliances for 3 months. QLF images will be taken before treatment (T0) and 3 months after commencement of the treatment (T1). The results will be compared between the two groups

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 24 Years

Eligibility

Inclusion Criteria:

• Healthy patients from both genders aged (17 - 24 years).

• Class I malocclusion with mild to moderate crowding (= 5 mm).

• Non-extraction treatment plan.

• Optimum oral Hygiene before treatment with no signs of gingivitis and/or periodontitis.

• Maximum of 3 restored teeth.

• Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

Exclusion Criteria:

-Patients with poor oral hygiene, defective enamel, extensive restorations and salivary glands diseases were excluded.

Related Conditions & MeSH terms

• Dental Caries
• White Spot Lesion

Intervention

Device:
• Orthodontic treatment with clear aligner
Included orthodontic treatment with clear aligner (eon Aligners)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta F	Incideance of Fluorescence loss	3 months
Primary	Lesion area	Incidence of the white spot lesion area	3 months
Secondary	Number of new lesions	The number of newly developed white spot lesion during orthodontic treatment	3 months
Secondary	?R30	Rate of plaque on tooth surfaces	3 months