Comparison Between Clear Aligners and Traditional Fixed Appliances in the Treatment of Four-premolar-extraction Cases

NCT ID: NCT03645356

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-19
• Study Completion Date: 2022-07-20

Brief Summary

Patients who have severe crowding that require four premolars extraction will be treated in this study. The efficacy of the clear aligners and vestibular fixed appliances will be assessed. The treatment result of these two different methods will be explored using the Peer Assessment Rating (PAR) in two different times (T0: Before treatment, T1: After treatment) and the American Board of Orthodontics Objective Grading System (ABO-OGS) after treatment (T1).

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. Today, 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.

Conditions

Malocclusion, Angle Class I; Malocclusion; Displaced or Missing Teeth; Crowding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

fixed appliances

patients will be treated using fixed appliances in order to align their teeth after extraction of four premolars

Group Type: ACTIVE_COMPARATOR

Fixed Appliances

Intervention Type: DEVICE

Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way

clear aligners

patients will be treated using clear aligners in order to align their teeth after extraction of four premolars

Group Type: EXPERIMENTAL

Clear Aligners

Intervention Type: DEVICE

Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment

Interventions

Fixed Appliances

Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way

Intervention Type: DEVICE

Clear Aligners

Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy).
• Good oral hygiene and periodontal health.
• No severe skeletal discrepancy.
• Normal proclination for the upper and lower incisors.
• 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

• Bimaxillary dentoalveolar severe protrusion.
• Previous orthodontic treatment.
• Subject with psychological abnormalities.
• Subject with systemic diseases.
• Subject has known allergy to latex and plastic

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samer T Jaber, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD Student in Orthodontics, University of Damascus Dental School, Damascus

Mohammad Y Hajeer, DDS MSc PhD

Role: STUDY_CHAIR

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

Locations

Department of Orthodontics, University of Damascus Dental School

Damascus, , Syria

Countries

Syria

References

Bollen AM, Huang G, King G, Hujoel P, Ma T. Activation time and material stiffness of sequential removable orthodontic appliances. Part 1: Ability to complete treatment. Am J Orthod Dentofacial Orthop. 2003 Nov;124(5):496-501. doi: 10.1016/s0889-5406(03)00576-6.

Reference Type: BACKGROUND

PMID: 14614415 (View on PubMed)

Drake CT, McGorray SP, Dolce C, Nair M, Wheeler TT. Orthodontic tooth movement with clear aligners. ISRN Dent. 2012;2012:657973. doi: 10.5402/2012/657973. Epub 2012 Aug 14.

Reference Type: BACKGROUND

PMID: 22928114 (View on PubMed)

Giancotti A, Di Girolamo R. Treatment of severe maxillary crowding using Invisalign and fixed appliances. J Clin Orthod. 2009 Sep;43(9):583-9; quiz 582. No abstract available.

Reference Type: BACKGROUND

PMID: 19904051 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25939782 (View on PubMed)

Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign. Am J Orthod Dentofacial Orthop. 2009 Jan;135(1):27-35. doi: 10.1016/j.ajodo.2007.05.018.

Reference Type: BACKGROUND

PMID: 19121497 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26221410 (View on PubMed)

Zhang XJ, He L, Guo HM, Tian J, Bai YX, Li S. Integrated three-dimensional digital assessment of accuracy of anterior tooth movement using clear aligners. Korean J Orthod. 2015 Nov;45(6):275-81. doi: 10.4041/kjod.2015.45.6.275. Epub 2015 Nov 20.

Reference Type: BACKGROUND

PMID: 26629473 (View on PubMed)

Other Identifiers

UDDS-Ortho-07-2018

Identifier Type: -

Identifier Source: org_study_id