Evaluation of the Efficiency of Single Aligner Appliance for Treatment of Mild Crowding Cases in Adults.

NCT ID: NCT04988373

Last Updated: 2024-05-02

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-23

Study Completion Date

2022-09-20

Brief Summary

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36 participants who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups.

1. In the experimental group, patients will be treated using single aligner appliance in order to align their crowding teeth.
2. Control group will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Detailed Description

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Most adult patients do not prefer traditional fixed appliances for aesthetic reasons, long treatment duration, and relatively difficult oral care. The current study came in order to evaluate the Efficiency of a new single aligner appliance that is both aesthetic and economical.

Conditions

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Crowding of Anterior Mandibular Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Single aligner appliance

Modified aligner appliance with NiTi springs

Group Type EXPERIMENTAL

Modified aligner appliance

Intervention Type DEVICE

Patients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.

Traditional fixed appliances

MBT-prescription of metallic brackets.

Group Type ACTIVE_COMPARATOR

Traditional fixed appliance

Intervention Type DEVICE

Patients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Interventions

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Modified aligner appliance

Patients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.

Intervention Type DEVICE

Traditional fixed appliance

Patients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults patients aged between (16 - 28) years.
2. Class I malocclusion with Mild crowding (1 - 4) mm in the anterior region of the mandibular dental arch
3. All lower teeth are existed (except for third molars).
4. No congenitally missing or extracted teeth (except for third molars)
5. Patients have not undergone previous orthodontic treatment.
6. Patient with good oral hygiene (Plaque Index less than 1).
7. With no severe skeletal discrepancy.

Exclusion Criteria

1. Bimaxillary dentoalveolar severe protrusion.
2. Any systemic diseases affect teeth movement.
3. Bad oral hygiene.
4. Patient lack of commitment toward follow-up appointments.
Minimum Eligible Age

16 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ziad M Alhafi, DDS

Role: PRINCIPAL_INVESTIGATOR

MSc student at the Orthodontic Department, University of Damascus Dental

Nada Rajeh, DDS,MSc,PhD

Role: STUDY_CHAIR

Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Locations

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Department of Orthodontics, University of Damascus Dental School

Damascus, , Syria

Site Status

Countries

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Syria

References

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Barrer HG. Protecting the integrity of mandibular incisor position through keystoning procedure and spring retainer appliance. J Clin Orthod. 1975 Aug;9(8):486-94. No abstract available.

Reference Type BACKGROUND
PMID: 1072074 (View on PubMed)

Qureshi A. The Inman Aligner for anterior tooth alignment. Dent Update. 2008 Oct;35(8):569-71, 574-6. doi: 10.12968/denu.2008.35.8.569.

Reference Type BACKGROUND
PMID: 19055094 (View on PubMed)

Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.

Reference Type BACKGROUND
PMID: 1059332 (View on PubMed)

Hennessy J, Al-Awadhi EA. Clear aligners generations and orthodontic tooth movement. J Orthod. 2016 Mar;43(1):68-76. doi: 10.1179/1465313315Y.0000000004.

Reference Type BACKGROUND
PMID: 25939782 (View on PubMed)

Hennessy J, Al-Awadhi EA. Clear aligners generations and orthodontic tooth movement. J Orthod. 2016 Jan 8:1-9. doi: 10.1080/14653125.2015.1108725. Online ahead of print.

Reference Type BACKGROUND
PMID: 26743036 (View on PubMed)

Alhafi ZM, Rajeh N. Evaluation of the effectiveness of modified aligner appliance with nickel-titanium springs in treatment of mild crowding of lower incisors: A randomized controlled clinical trial. J World Fed Orthod. 2022 Aug;11(4):107-113. doi: 10.1016/j.ejwf.2022.04.003. Epub 2022 May 24.

Reference Type DERIVED
PMID: 35624004 (View on PubMed)

Other Identifiers

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UDDS-Ortho-06-2021

Identifier Type: -

Identifier Source: org_study_id

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