Evaluation of Dentoalveolar Changes of Clear Aligners Versus Fixed Orthodontic Appliances on Skeletal Class I Non-extraction Patients With Dental Crowding

NCT07090746 | Active Not Recruiting

• 1 other identifier: A0208023OR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate dentoalveolar changes of clear aligners versus fixed orthodontic appliances on skeletal class I non-extraction patients with dental crowding.

Conditions

Skeletal Class I Non-extraction Patients With Dental Crowding

Keywords

clear aligners

Outcome Measures

Primary Outcomes (2)

• Alveolar bone thickness

  Alveolar bone thickness will be assessed in vestibular and oral sides, parallel to the cervical reference line (CRL) at 3 different evels and expressed in millimeters.

  From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.

• Alveolar bone height

  Alveolar bone height loss will be measured perpendicularly to the CRL in both vestibular and oral sides. It will be represented as the difference between pretreatment and post treatment distance from alveolar crest to the CRL, expressed in millimeters.

  From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.

Secondary Outcomes (2)

• Comparison of transverse dental changes between the two groups.

  From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.

• Assessment of Apical root resorption

  From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.

Study Arms (2)

Non extraction crowding cases for clear aligner

ACTIVE COMPARATOR

Device: Clear aligner

Non extraction crowding cases for fixed orthodontic appliance

ACTIVE COMPARATOR

Device: Fixed orthodontic appliance

Interventions

Clear aligner DEVICE

Clear aligner

Non extraction crowding cases for clear aligner

Fixed orthodontic appliance DEVICE

Fixed orthodontic appliance

Non extraction crowding cases for fixed orthodontic appliance

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Complete permanent dentition.
• Angle Class I malocclusion cases with mild to moderate crowding (2-6 mm) that can be resolved by dental expansion and interproximal reduction (IPR).
• Good oral hygiene.

You may not qualify if:

• Bad oral hygiene.
• Previous orthodontic treatment.
• Periodontal disease and previous periodontal surgery procedures.
• Systemic diseases and/or craniofacial syndromes.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry mansoura university

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Orthodontic Appliances, Removable; Orthodontic Appliances, Fixed

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 29, 2025
• Study Start: December 30, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-07

Locations

EG (1)