- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07514403
Bilogical Assesment During Intrusion of Lower Incisors
May 4, 2026 updated by: Alaa Eldin Elshahat Shafay Ali, Al-Azhar University
Assessment of the Biological Response of the Corticision During Intrusion of Lower Incisors A Prospective Clinical Study
biological assesment during intrusion of lower incisors
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Assessment of the biological response of the corticision during intrusion of lower incisors A prospective clinical study
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 Contact
- Name: alaa eldin elshahat shafay, post gradute student
- Phone Number: +201016886788
- Email: alaaelshafay9@gmail.com
Study Contact Backup
- Name: Mahmoud Fathy Aboelmahasen, lecturer
- Phone Number: 01222993381
- Email: MahmoudFathy.209@azhar.edu.eg
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients requiring extraction-based orthodontic treatment
- Presence of deep overbite requiring lower incisor intrusion
- Age range: 18-30 years
- Good general health
- Good oral hygiene
Exclusion Criteria:
- Systemic diseases affecting bone metabolism
- Previous orthodontic treatment
- Periodontal disease
- Smoking
- Pregnancy or lactation
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: controlled
without corticision
|
|
|
Active Comparator: active group
corticision group
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels measured by enzyme-linked immunosorbent assay (ELISA) (pg/mL)
Time Frame: 12 weeks
|
GCF samples will be collected from lower incisors using microcapillary tubes at baseline and during follow-up visits.
Prostaglandin E2 levels will be quantified using ELISA kits and expressed in pg/mL to assess the biological response to corticision-assisted intrusion.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Amount of lower incisor intrusion measured in millimeters (mm) using cone beam computed tomography (CBCT)
Time Frame: 12 weeks
|
CBCT imaging will be used to measure the vertical displacement of lower incisors in millimeters by comparing pre- and post-treatment positions.
|
12 weeks
|
|
External apical root resorption measured in millimeters (mm) using cone beam computed tomography (CBCT)
Time Frame: Time Frame: 12 weeks
|
CBCT imaging will be used to assess external apical root resorption by comparing root lengths before and after treatment.
|
Time Frame: 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ramadan Yu Abu-shahba, professor, Al-Azhar University, Faculty of Dental Medicine
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 (Estimated)
April 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
August 1, 2027
Study Registration Dates
First Submitted
March 25, 2026
First Submitted That Met QC Criteria
March 30, 2026
First Posted (Actual)
April 7, 2026
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 936/3891
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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