Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04107012

Enrollment

Registered

2019-09-27

Start date

2016-09-30

Completion date

2018-09-30

Last updated

2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion

Keywords

White spot lesion, QLF, Clear aligners

Brief 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)

Detailed 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

Interventions

DEVICEOrthodontic treatment with clear aligner

Included orthodontic treatment with clear aligner (eon Aligners)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

17 Years to 24 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Delta F	3 months	Incideance of Fluorescence loss
Lesion area	3 months	Incidence of the white spot lesion area

Secondary

Measure	Time frame	Description
Number of new lesions	3 months	The number of newly developed white spot lesion during orthodontic treatment
ΔR30	3 months	Rate of plaque on tooth surfaces

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026