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

Crowding of Anterior Mandibular Teeth Clinical Trial

Official title:

Evaluation of the Efficiency of Modified Aligner Appliance With NiTi Springs for Treatment of Mild Crowding Cases in Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988373
• Other study ID #: UDDS-Ortho-06-2021
• Status: Completed
• Phase: N/A
• Start date: July 23, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 20, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 28 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crowding of Anterior Mandibular Teeth

Intervention

Device:
• Modified aligner appliance
Patients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.
• Traditional fixed appliance
Patients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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