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Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior Crowding

Sponsor
Al-Azhar University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05737290
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate effects of clear aligners versus fixed appliances on occlusion after treatment of mild anterior crowding a T-scan study.

Condition or Disease Intervention/Treatment Phase
  • Device: Clear aligners
  • Device: Fixed appliances
 N/A

Detailed Description

Intervention:

Group 1. Patients treated with clear aligner. Patients with mild anterior crowding will be treated with non-extraction treatment using clear aligners.

Group 2. Patients treated with fixed appliance. Patients with mild anterior crowding will be treated with non-extraction treatment using fixed appliances.

Observations:

Multi-bite closure of left and right excursive T-Scan® recordings were obtained before and after treatment from each subject to measure the occlusal parameters to be analyzed during this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior Crowding: A T-scan Study.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

Device: Clear aligners
Patients with mild anterior crowding will be treated with non-extraction treatment using clear aligners.
Active Comparator: Group B

Device: Fixed appliances
Patients with mild anterior crowding will be treated with non-extraction treatment using fixed appliances.

Outcome Measures

Primary Outcome Measures

  1. Distribution of occlusal forces [At 6 months]

    Amount of magnitude of occlusal forces after treatment by clear aligners

  2. Distribution of occlusal forces [At 6 months]

    Amount of magnitude of occlusal forces after treatment by fixed appliances

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patients between the age (14-19 y).

  • Fully erupted permanent dentition, 3rd molars excluded.

  • Healthy, compliant, and motivated patients who can visit the department regularly.

  • Non-extraction treatment.

  • Class I with mild anterior crowding lower and/ or upper.

  • Good oral and general health.

Exclusion Criteria:

  • Previous orthodontic treatment.

  • Craniofacial abnormalities, congenital syndromes of the craniofacial area.

  • Anterior or posterior crossbite.

  • Anterior or lateral open bite.

  • Poor oral hygiene or periodontally compromised patient.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Al Azhar University Cairo Nasr City Egypt 11765

Sponsors and Collaborators

  • Al-Azhar University

Investigators

  • Principal Investigator: Moaz Hafez Abdelrhman, Master, Al-Azhar University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Moaz Hafez Abdelrahman Hafez, Doctor, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05737290
Other Study ID Numbers:
  • 893/2838
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 22, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Moaz Hafez Abdelrahman Hafez, Doctor, Al-Azhar University
Clear aligners
Fixed appliances
Anterior crowding
Occlusion
T scan

Study Results

No Results Posted as of Feb 22, 2023