NCT07514403

Brief Summary

biological assesment during intrusion of lower incisors

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Apr 2026

Status
not yet recruiting

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

Study Progress8%
Apr 2026Aug 2027

First Submitted

Initial submission to the registry

March 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

March 25, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Orthodontics Malocclusion Corticision

Outcome Measures

Primary Outcomes (1)

  • Gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels measured by enzyme-linked immunosorbent assay (ELISA) (pg/mL)

    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 Outcomes (2)

  • Amount of lower incisor intrusion measured in millimeters (mm) using cone beam computed tomography (CBCT)

    12 weeks

  • External apical root resorption measured in millimeters (mm) using cone beam computed tomography (CBCT)

    Time Frame: 12 weeks

Study Arms (2)

controlled

NO INTERVENTION

without corticision

active group

ACTIVE COMPARATOR

corticision group

Other: Corticision

Interventions

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.

active group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Systemic diseases affecting bone metabolism
  • Previous orthodontic treatment
  • Periodontal disease
  • Smoking
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ramadan Yu Abu-shahba, professor

    Al-Azhar University, Faculty of Dental Medicine

    STUDY DIRECTOR

Central Study Contacts

alaa eldin elshahat shafay, post gradute student

CONTACT

Mahmoud Fathy Aboelmahasen, lecturer

CONTACT

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
postgraduate researcher

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 7, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04