Clinical trial NCT04988373: Evaluation of the Efficiency of Single Aligner Appliance for Treatment of Mild Crowding Cases in Adults.
Official title: Evaluation of the Efficiency of Modified Aligner Appliance With NiTi Springs for Treatment of Mild Crowding Cases in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crowding of Anterior Mandibular Teeth
Keywords: Mild crowding
Aligner
Orthodontic treatment
Crowded anterior teeth
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of Alignment
timeFrame: 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
measure: Change in Little's Index of Irregularity
timeFrame: 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
measure: Change in Lower Incisors Inclination
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student at the Orthodontic Department, University of Damascus Dental
name: Ziad M Alhafi, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Nada Rajeh, DDS,MSc,PhD
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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.
citation: 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.