Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment

NCT ID: NCT04107012

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-09-30

Brief Summary

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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

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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

Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clear Aligner

Group 1 treated with clear aligners

Group Type EXPERIMENTAL

Orthodontic treatment with clear aligner

Intervention Type DEVICE

Included orthodontic treatment with clear aligner (eon Aligners)

Fixed appliance

Group 2 treated with conventional fixed appliances

Group Type ACTIVE_COMPARATOR

Orthodontic treatment with clear aligner

Intervention Type DEVICE

Included orthodontic treatment with clear aligner (eon Aligners)

Interventions

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Orthodontic treatment with clear aligner

Included orthodontic treatment with clear aligner (eon Aligners)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.

Reference Type DERIVED
PMID: 32354432 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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JUST20160295

Identifier Type: -

Identifier Source: org_study_id

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