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

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

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.

Study Overview

• Status: Completed
• Conditions: Crowding of Anterior Mandibular Teeth
• Intervention / Treatment: Device: Modified aligner appliance; Device: Traditional fixed appliance

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic
    • Department of Orthodontics, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single aligner appliance; Modified aligner appliance with NiTi springs	Device: Modified aligner appliance; Patients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.
Active Comparator: Traditional fixed appliances; MBT-prescription of metallic brackets.	Device: Traditional fixed appliance; Patients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the perception of self-reported pain	At each adjustment visit, patients in both groups will be given a prepared Self-reported pain questionnaire to complete over the following week and to be returned at each subsequent visit. This questionnaire records pain by means of a 100 mm visual analogue scale (VAS). The left end of the line refers to no pain (VAS=0) where the right end refers to maximum pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.	: 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 the perception of discomfort	At each adjustment visit, patients in both groups will be given a prepared discomfort questionnaire to complete over the following week and to be returned at each subsequent visit. This questionnaire records discomfort by means of a 100 mm visual analogue scale (VAS). The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum discomfort (VAS=100). The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.	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
The change in the plaque index	Assessment will be achieved using a gingival probe according to Silness and Loe (1964). The criteria for plaque index as: 0: No plaque; A film of plaque adheres to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using probe on the tooth surface.; Moderate accumulation of soft deposits within the gingival pocket, or the tooth and the gingival margin, which can be seen with the naked eye.; An abundance of soft matter within the gingival pocket and/or the tooth and gingival margin.	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
The change in the gingival index index	Assessment will be achieved using a gingival probe according to Silness and Loe (1964). The criteria for gingival index as: 0: Normal gingiva.; Mild inflammation: slight change in colour, slight oedema, no bleeding on probing.; Moderate inflammation: moderate glazing, redness, oedema, and hypertrophy, bleeding on probing.; Severe inflammation: marked redness and hypertrophic ulceration, tendency to spontaneous bleeding	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)
The change in papillary bleeding index	Assessment will be achieved using a gingival probe according to Muhlemann (1977). 0: No bleeding.; A single discreet bleeding point appears.; Several isolated bleeding points or a single fine line of blood appears.; The interdental triangle fills with blood shortly after probing.; Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.	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)
Changes in oral health related quality of life	Patients in both groups will be given a questionnaire to be filled at each adjustment visit. The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14). OHIP-14 includes a subjective evaluation of the individual's oral health, functional well-being, emotional well-being, expectations and satisfaction with care and sense of self.	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
Patients' satisfaction	Patients in both groups will be asked two questions about satisfaction with the appearance of the orthodontic appliance and satisfaction with the progress and results of the treatment. The answer will be collected using three-point scale (1. good or 2. moderate or 3. bad ).	At the end of leveling and alignment which is expected to occur within 4 to 6 months
The possibility of repeating the procedure	Patients in both groups will be asked about the possibility of repeating the procedure if they had the chance to give their decision again. The answer will be collected using three-point scale (1. yes or 2. No).	At the end of leveling and alignment which is expected to occur within 4 to 6 months
Recommendation to a friend	Patients in both groups will be asked about if they would recommend this procedure to a friend. The answer will be collected using a two-point scale (1. Yes or 2. No).	At the end of leveling and alignment which is expected to occur within 4 to 6 months

Collaborators and Investigators

• Sponsor: Damascus University
• Investigators: Principal Investigator: Ziad M Alhafi, DDS, MSc student at the Orthodontic Department, University of Damascus Dental; Study Chair: Nada Rajeh, DDS,MSc,PhD, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Orthodontic treatment; Mild crowding; Aligner; Crowded anterior teeth
• Other Study ID Numbers: UDDS-Ortho-06-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No