NCT05604612

Brief Summary

the goal of this clinical trial is to assess the effectiveness of the corticision with self-ligating bracket system on the acceleration of orthodontic tooth movement.The main question it aims to answer is whether or not there would be an augmented effect by undergoing corticision with using self-ligating brackets regarding the acceleration of orthodontic tooth movement.

Trial Health

35
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 Jan 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 30, 2022

Last Update Submit

October 30, 2022

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

  • Little's Irregularity Index

    crowding resolution

    two months

Study Arms (2)

Experimental

EXPERIMENTAL
Procedure: Corticision

Active Comparator

NO INTERVENTION

Interventions

CorticisionPROCEDURE

Incisions in the cortical plate of maxillary bone

Experimental

Eligibility Criteria

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

You may qualify if:

  • Class I orthodontic patients with mild to moderate crowding of upper anterior segment (2-4 mm) All permanent teeth are erupted (3rd molar not included). Good oral and general health No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement No previous orthodontic treatment.

You may not qualify if:

  • Orthodontic cases with severe crowding of upper anterior segment that require extraction treatment approach. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment. Patients with untreated decay or endodontic lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Hazem Abd Elhafeez

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 3, 2022

Study Start

January 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

November 3, 2022

Record last verified: 2022-10