NCT05737290

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 6, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

February 6, 2023

Last Update Submit

July 18, 2023

Conditions

Keywords

Clear alignersFixed appliancesAnterior crowdingOcclusionT scan

Outcome Measures

Primary Outcomes (2)

  • Distribution of occlusal forces

    Amount of magnitude of occlusal forces after treatment by clear aligners

    At 6 months

  • Distribution of occlusal forces

    Amount of magnitude of occlusal forces after treatment by fixed appliances

    At 6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR
Device: Clear aligners

Group B

ACTIVE COMPARATOR
Device: Fixed appliances

Interventions

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

Group A

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

Group B

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University

Cairo, Nasr City, 11765, Egypt

Location

Related Publications (1)

  • Weir T. Invisalign treatment of lower incisor extraction cases. Aust Orthod J. 2016 May;32(1):82-7.

    PMID: 27468595BACKGROUND

MeSH Terms

Conditions

Bites and Stings

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Moaz Hafez Abdelrhman, Master

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 21, 2023

Study Start

December 1, 2023

Primary Completion

February 1, 2024

Study Completion

June 1, 2024

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months

Locations