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The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases

Primary Purpose

Crowding, Tooth

Status

Completed

Phase

Not Applicable

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

Clear aligners

Fixed appliances

About this trial

This is an interventional treatment trial for Crowding, Tooth focused on measuring Clear aligners, PAR index, Vestibular fixed appliances, Orthodontics, Crowding, Treatment duration

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Class I skeletal and dental malocclusion
severe crowding (more than 6 mm of tooth size-arch length discrepancy)
Good oral hygiene and periodontal health.
No congenitally missing or extracted teeth (except for the third molars).
No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

Subject with psychological abnormalities.
Subject with systemic diseases.
Previous orthodontic treatment.
Subject has known allergy to latex and plastic

Sites / Locations

University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clear aligners

Fixed appliances.

Arm Description

The patients in this group will be treated using clear aligners.

The patients in this group will be treated using fixed appliances.

Outcomes

Primary Outcome Measures

Change in PAR index

The PAR index will be used to provide objective assessment of treatment success. Each set of dental models prepared before and after treatment for each case will be occluded in maximum intercuspation and a calibrated PAR ruler is used to assign a value to each of the PAR index components: contact displacement in the upper and lower labial segment (UAS), overjet (OJ), overbite (OB), medline deviation (MID) and right and left buccazzzl occlusion (RBO, LBO). The score of each component is summed up to a total PAR score. A reduction in the PAR score of at least 30% classifies the case as 'improved'. A reduction of 22 points or more in the weighted PAR score classifies the case as 'greatly improved'. Improvements smaller than 30% are declared as 'worse or no different'

Changes in Little's irregularity index

The Little's index measures the linear displacements in the horizontal plane between the contact points of the anterior teeth from the mesial surface of one canine to the contralateral one. The LII score is the sum of these linear measurements, and a higher score value indicates more severe irregularities of the anterior teeth

Secondary Outcome Measures

Treatment time

The treatment duration was calculated by months and will be compared between the groups

Full Information

NCT ID

NCT05500456

First Posted

August 11, 2022

Last Updated

August 11, 2022

Sponsor

Damascus University

1. Study Identification

Unique Protocol Identification Number

NCT05500456

Brief Title

The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases

Official Title

Evaluation of the Achieved Occlusal Relationships Using the PAR Index Between the In-house Constructed Clear Aligners and Fixed Appliances in Patients With Extraction-based Treatment Plans: A Randomized Control Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

May 11, 2019 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Patients who have severe crowding that requires four premolars extraction will be treated in this study. The efficacy and effectiveness of in-house clear aligners therapy compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using Little's irregularity index (LII), Peer assessment rating index (PAR), and treatment duration. There are two groups: First group (Experimental): the patients in this group will be treated using clear aligners. Second group (Control): the patients in this group will be treated using fixed appliances.

Detailed Description

For years, orthodontists and dentists have used removable appliances for orthodontic treatment. With the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consist of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom-manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crowding, Tooth

Keywords

Clear aligners, PAR index, Vestibular fixed appliances, Orthodontics, Crowding, Treatment duration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clear aligners

Arm Type

Experimental

Arm Description

The patients in this group will be treated using clear aligners.

Arm Title

Fixed appliances.

Arm Type

Active Comparator

Arm Description

The patients in this group will be treated using fixed appliances.

Intervention Type

Device

Intervention Name(s)

Clear aligners

Intervention Description

Each aligner will be worn for about two weeks, and then replaced by the next in the series until the final position is achieved.

Intervention Type

Device

Intervention Name(s)

Fixed appliances

Intervention Description

Conventional wires and brackets will be used.

Primary Outcome Measure Information:

Title

Change in PAR index

Description

Time Frame

T0: one day before the commencement of treatment. T1: one day following the end of treatment

Title

Changes in Little's irregularity index

Description

Time Frame

T0: one day before the commencement of treatment. T1: one day following the end of treatment

Secondary Outcome Measure Information:

Title

Treatment time

Description

The treatment duration was calculated by months and will be compared between the groups

Time Frame

T1: one day following the end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Class I skeletal and dental malocclusion severe crowding (more than 6 mm of tooth size-arch length discrepancy) Good oral hygiene and periodontal health. No congenitally missing or extracted teeth (except for the third molars). No history of previous trauma to the maxillofacial region or surgical interventions. Exclusion Criteria: Subject with psychological abnormalities. Subject with systemic diseases. Previous orthodontic treatment. Subject has known allergy to latex and plastic

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samer T Jaber, DDS,MSc

Organizational Affiliation

Department of orthodontics, Damascus University, Syria

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammad Y Hajeer, DDS,MSc,PhD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

University of Damascus

City

Damascus

Country

Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35663697

Citation

Jaber ST, Hajeer MY, Burhan AS, Latifeh Y. The Effect of Treatment With Clear Aligners Versus Fixed Appliances on Oral Health-Related Quality of Life in Patients With Severe Crowding: A One-Year Follow-Up Randomized Controlled Clinical Trial. Cureus. 2022 May 30;14(5):e25472. doi: 10.7759/cureus.25472. eCollection 2022 May.

Results Reference

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PubMed Identifier

33258297

Citation

Jaber ST, Hajeer MY, Khattab TZ, Mahaini L. Evaluation of the fused deposition modeling and the digital light processing techniques in terms of dimensional accuracy of printing dental models used for the fabrication of clear aligners. Clin Exp Dent Res. 2021 Aug;7(4):591-600. doi: 10.1002/cre2.366. Epub 2020 Nov 30.

Results Reference

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PubMed Identifier

26221410

Citation

Li W, Wang S, Zhang Y. The effectiveness of the Invisalign appliance in extraction cases using the the ABO model grading system: a multicenter randomized controlled trial. Int J Clin Exp Med. 2015 May 15;8(5):8276-82. eCollection 2015.

Results Reference

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PubMed Identifier

28670875

Citation

Liu S, Oh H, Chambers DW, Baumrind S, Xu T. Validity of the American Board of Orthodontics Discrepancy Index and the Peer Assessment Rating Index for comprehensive evaluation of malocclusion severity. Orthod Craniofac Res. 2017 Aug;20(3):140-145. doi: 10.1111/ocr.12195. Epub 2017 Jul 3.

Results Reference

background

PubMed Identifier

21027613

Citation

KESLING HD. Coordinating the predetermined pattern and tooth positioner with conventional treatment. Am J Orthod Oral Surg. 1946 May;32:285-93. doi: 10.1016/0096-6347(46)90053-1. No abstract available.

Results Reference

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The Effectiveness of Clear Aligner and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases

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