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OpenTrials
Completed

NCT Number: NCT04107012

Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment

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)

Completed

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Key information

Conditions

White Spot Lesion

Age range

17 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthodontic treatment with clear aligner

Device

Included orthodontic treatment with clear aligner (eon Aligners)

Primary outcomes

  1. Delta F

    Time frame: 3 months

    Incideance of Fluorescence loss

  2. Lesion area

    Time frame: 3 months

    Incidence of the white spot lesion area

Secondary outcomes

  1. Number of new lesions

    Time frame: 3 months

    The number of newly developed white spot lesion during orthodontic treatment

  2. ΔR30

    Time frame: 3 months

    Rate of plaque on tooth surfaces

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 27, 2019
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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