Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment

September 25, 2019 updated by: Jordan University of Science and Technology

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clear Aligner
Group 1 treated with clear aligners
Device: Orthodontic treatment with clear aligner
Included orthodontic treatment with clear aligner (eon Aligners)
Active Comparator: Fixed appliance
Group 2 treated with conventional fixed appliances
Device: Orthodontic treatment with clear aligner
Included orthodontic treatment with clear aligner (eon Aligners)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JUST20160295

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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