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

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

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
  1. Prior panoramic x-ray or serial periapical x-rays are essential to assure the availability of interradicular room to carry out the procedure.
  2. Preoperative antiseptic mouthwash is administered to prevent potential infections.
  3. Infiltration anesthesia is applied.
  4. A reinforced 15T scalpel is positioned on the interradicular attached gingiva at an inclination of 45-60 degrees on the long axis of the tooth to be moved.

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.

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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