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

NCT03645356 | Completed DMC

• 1 other identifier: UDDS-Ortho-07-2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in the American Board of Orthodontics - Objective Grading System (ABO-OGS)

  Eight domains are evaluated: Alignment: No more than 2 points shall be subtracted for any tooth when it is poorly aligned; Marginal Ridges: The total number of deductions shall be subtracted from 32 to give the score for this domain; Buccolingual inclination: If the mandibular lingual cusps or maxillary buccal cusps are more than 1 mm from the straight edge surface, 1 point shall be subtracted for that tooth; Occlusal Contacts: If a cusp is out of contact with the opposing arch, 1 point is subtracted for that tooth; Occlusal relationships. The total number of deductions are subtracted from 24 to give the score for occlusal relationships; Overjet; Interproximal contacts. If no interproximal spaces exist, then no points are subtracted; and Root angulation: Any deviations in roots' angulations will cause a deduction form the general score. Finally, a case that loses more than 30 points will be considered a failure. A case that loses less than 20 points will be considered acceptable.

  T1: one day before the commencement of treatment. T2: one day following the end of treatment (that is expected to happen within 24 months)

Study Arms (2)

fixed appliances

ACTIVE COMPARATOR

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

Device: Fixed Appliances

clear aligners

EXPERIMENTAL

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

Device: Clear Aligners

Interventions

Fixed Appliances DEVICE

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

fixed appliances

Clear Aligners DEVICE

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

clear aligners

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (7)

• 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.

  PMID: 14614415 BACKGROUND

• 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.

  PMID: 22928114 BACKGROUND

• 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.

  PMID: 19904051 BACKGROUND

• 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.

  PMID: 25939782 BACKGROUND

• 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.

  PMID: 19121497 BACKGROUND

• 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.

  PMID: 26221410 BACKGROUND

• 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.

  PMID: 26629473 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class I; Malocclusion; Anodontia; Crowding

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spatial Behavior; Behavior

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Samer T Jaber, DDS MSc

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

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: August 19, 2018
• Primary Completion: December 10, 2021
• Study Completion: July 20, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)