NCT05232318

Brief Summary

The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

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

December 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

December 18, 2021

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Amount of Root resorption

    Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software

    8 months

Study Arms (3)

leveling and alignment using fixed orthodontic appliance

ACTIVE COMPARATOR

leveling and alignment using fixed orthodontic appliance

Other: Leveling and alignment

leveling and alignment using clear aligner

EXPERIMENTAL

leveling and alignment using clear aligner

Other: Leveling and alignment

leveling and alignment using clear aligner with low level laser therapy

EXPERIMENTAL

leveling and alignment using clear aligner with low level laser therapy

Other: Leveling and alignment

Interventions

Root resorption comparison through the use of CBCT

leveling and alignment using clear alignerleveling and alignment using clear aligner with low level laser therapyleveling and alignment using fixed orthodontic appliance

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy systemic condition/no systemic illness, as reported by patients.
  • No use any form of anti - inflammatory drugs the at beginning of study.
  • Good oral hygiene.
  • Cooperative and motivated.
  • In the permanent dentition with all teeth present ( except third molars).
  • Minimum to moderate anterior crowding.
  • No previous orthodontic treatment.

You may not qualify if:

  • Previous upper removable orthodontic treatment.
  • Patients who required surgery to correct skeletal discrepancies.
  • Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
  • Uncooperative patients.
  • Patients with poor oral hygiene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AlAzhar Azhar University

Cairo, Or, Egypt

RECRUITING

Al Azhar university

Cairo, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Officials

  • Ahmed M Abouelnour, Lecturer

    Lecturer, Department of Orthodontics

    STUDY DIRECTOR
  • Ramadan Y Aboushahba, Associate professor

    Associate professor, Department of Orthodontics

    STUDY CHAIR

Central Study Contacts

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2021

First Posted

February 9, 2022

Study Start

April 1, 2022

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations