NCT04107012

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)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

July 14, 2019

Last Update Submit

September 25, 2019

Conditions

White Spot Lesion

Keywords

White spot lesionQLFClear aligners

Outcome Measures

Primary Outcomes (2)

  • Delta F

    Incideance of Fluorescence loss

    3 months

  • Lesion area

    Incidence of the white spot lesion area

    3 months

Secondary Outcomes (2)

  • Number of new lesions

    3 months

  • ΔR30

    3 months

Study Arms (2)

Clear Aligner

EXPERIMENTAL

Group 1 treated with clear aligners

Device: Orthodontic treatment with clear aligner

Fixed appliance

ACTIVE COMPARATOR

Group 2 treated with conventional fixed appliances

Device: Orthodontic treatment with clear aligner

Interventions

Orthodontic treatment with clear alignerDEVICE

Included orthodontic treatment with clear aligner (eon Aligners)

Clear AlignerFixed appliance

Eligibility Criteria

Age17 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32354432DERIVED

MeSH Terms

Interventions

Orthodontics

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2019

First Posted

September 27, 2019

Study Start

September 1, 2016

Primary Completion

January 1, 2018

Study Completion

September 1, 2018

Last Updated

September 27, 2019

Record last verified: 2019-09