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

NCT04988373 | Completed DMC

• 1 other identifier: UDDS-Ortho-06-2021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Crowding of Anterior Mandibular Teeth

Keywords

Mild crowding; Aligner; Orthodontic treatment; Crowded anterior teeth

Outcome Measures

Primary Outcomes (3)

• Duration of Alignment

  The time required in days will be calculated from the beginning of treatment till the end of the alignment stage.

  The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 4 to 6 months

• Change in Little's Index of Irregularity

  The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.

  T0: immediately before the start of orthodontic treatment; T1: after one month; T2: after two months; T3: after three months; T4: after four months; T5: at the end of the alignment stage (which is expected to occur within 4 to 6 months

• Change in Lower Incisors Inclination

  The angle between the long axis of the lower Incisors and the mandible plane (Go-Me) will be measured using Cephalometric x ray.

  immediately before the start of orthodontic treatment; T1: at the end of the alignment stage which is expected to happen within 4 to 6 months

Study Arms (2)

Single aligner appliance

EXPERIMENTAL

Modified aligner appliance with NiTi springs

Device: Modified aligner appliance

Traditional fixed appliances

ACTIVE COMPARATOR

MBT-prescription of metallic brackets.

Device: Traditional fixed appliance

Interventions

Modified aligner appliance DEVICE

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

Single aligner appliance

Traditional fixed appliance DEVICE

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

Traditional fixed appliances

Eligibility Criteria

• Age: 16 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Bimaxillary dentoalveolar severe protrusion.
• Any systemic diseases affect teeth movement.
• Bad oral hygiene.
• Patient lack of commitment toward follow-up appointments.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 1072074 BACKGROUND

• 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.

  PMID: 19055094 BACKGROUND

• 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.

  PMID: 1059332 BACKGROUND

• 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.

  PMID: 25939782 BACKGROUND

• 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.

  PMID: 26743036 BACKGROUND

• 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.

  PMID: 35624004 DERIVED

Study Officials

• Ziad M Alhafi, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental

  PRINCIPAL INVESTIGATOR

• Nada Rajeh, DDS,MSc,PhD

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

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 3, 2021
• Study Start: July 23, 2021
• Primary Completion: January 28, 2022
• Study Completion: September 20, 2022
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)