NCT05500456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

August 11, 2022

Last Update Submit

August 11, 2022

Conditions

Crowding, Tooth

Keywords

Clear alignersPAR indexVestibular fixed appliancesOrthodonticsCrowdingTreatment duration

Outcome Measures

Primary Outcomes (2)

  • 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'

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

  • 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

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

Secondary Outcomes (1)

  • Treatment time

    T1: one day following the end of treatment

Study Arms (2)

Clear aligners

EXPERIMENTAL

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

Device: Clear aligners

Fixed appliances.

ACTIVE COMPARATOR

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

Device: Fixed appliances

Interventions

Clear alignersDEVICE

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

Clear aligners
Fixed appliancesDEVICE

Conventional wires and brackets will be used.

Fixed appliances.

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (5)

  • 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.

    PMID: 35663697BACKGROUND

  • 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.

    PMID: 33258297BACKGROUND

  • 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: 26221410BACKGROUND

  • 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.

    PMID: 28670875BACKGROUND

  • 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.

    PMID: 21027613BACKGROUND

MeSH Terms

Conditions

MalocclusionCrowding

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesSpatial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Samer T Jaber, DDS,MSc

    Department of orthodontics, Damascus University, Syria

    PRINCIPAL INVESTIGATOR

  • Mohammad Y Hajeer, DDS,MSc,PhD

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

    STUDY DIRECTOR

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 11, 2022

First Posted

August 15, 2022

Study Start

May 11, 2019

Primary Completion

March 1, 2021

Study Completion

December 15, 2021

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)