- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07480148
Self-activated Leaf Expander Versus William's Expander in Expansion of Collapsed Mandibular Arch
March 14, 2026 updated by: Abdalla Kamal, Al-Azhar University
Self-activated Leaf Expander Versus William's Expander in Expansion of Collapsed Mandibular Arch: A Prospective Clinical Trail
Self-activated leaf expander versus William's expander in expansion of collapsed mandibular arch
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The current randomized clinical study will be directed to compare the selfactivated leaf expander to William's expander for the expansion of collapsed mandibular arch.
Study Type
Interventional
Enrollment (Estimated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Naşr, Egypt
- Alazhar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
An age from 12-16 years.
- Low to average facial vertical pattern.
- A mild to moderate crowding in mandibular arch with reduced transverse dimension which require non extraction orthodontic approach.
- Similar amount of crowding on each side of the mandibular arch.
- No previous orthodontic treatment.
- Good oral and general health.
Exclusion Criteria:
Severe crowding.
- Steep mandibular plane.
- Asymmetric crowding on both sides of the arch.
- Shifting of mandibular dental midline.
- Impacted lower 2nd premolar.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: self activated leaf expander
Eight patients will be treated by self-activated leaf expander that does not need activation by the patient.
|
Eight patients will be treated by self-activated leaf expander that does not need activation by the patient.
|
|
Active Comparator: william's expander
Eight patients will be treated with William's expander, where the arms of expander will be placed parallel to the line of occlusion at the middle of lingual surface of the anterior teeth with two bands on lower permanent first molars.
|
Eight patients will be treated with William's expander, where the arms of expander will be placed parallel to the line of occlusion at the middle of lingual surface of the anterior teeth with two bands on lower permanent first molars.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intercanine width
Time Frame: 6 months
|
comparing the selfactivated leaf expander to William's expander for the expansion of collapsed lower arch by CBCT mandibular arch.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2024
Primary Completion (Estimated)
June 12, 2026
Study Completion (Estimated)
November 30, 2026
Study Registration Dates
First Submitted
November 18, 2024
First Submitted That Met QC Criteria
March 14, 2026
First Posted (Actual)
March 18, 2026
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 14, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 894/2938
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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