Orthodontic Treatment EfficiencyNCT07514403
Bilogical Assesment During Intrusion of Lower Incisors
A study testing Corticision in people with Orthodontic Treatment Efficiency, run by Al-Azhar University.
Trial summary
biological assesment during intrusion of lower incisors Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Treatment Efficiency
- What is being tested?
- Corticision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Systemic diseases affecting bone metabolism
- Previous orthodontic treatment
- Periodontal disease
- Smoking
- Pregnancy or lactation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Biological Response of the Corticision During Intrusion of Lower Incisors A Prospective Clinical Study
biological assesment during intrusion of lower incisors
Read the detailed description
Assessment of the biological response of the corticision during intrusion of lower incisors A prospective clinical study
- Conditions
- Orthodontic Treatment Efficiency
- Being tested
- Corticision
- Keywords
- Orthodontics Malocclusion Corticision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticisionOther
- Prior panoramic x-ray or serial periapical x-rays are essential to assure the availability of interradicular room to carry out the procedure.
- Preoperative antiseptic mouthwash is administered to prevent potential infections.
- Infiltration anesthesia is applied.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| controlled | No intervention | without corticision |
| active group | Active comparator | corticision group Receives: Other: Corticision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
Amount of lower incisor intrusion measured in millimeters (mm) using cone beam computed tomography (CBCT)
CBCT imaging will be used to measure the vertical displacement of lower incisors in millimeters by comparing pre- and post-treatment positions.
Measured: 12 weeks
External apical root resorption measured in millimeters (mm) using cone beam computed tomography (CBCT)
CBCT imaging will be used to assess external apical root resorption by comparing root lengths before and after treatment.
Measured: Time Frame: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Treatment EfficiencyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Eldin Elshahat Shafay Ali, Al-Azhar University
- Investigators
- Ramadan Yu Abu-shahba, professor, Study director, Al-Azhar University, Faculty of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514403
- Sponsor's protocol ID
- 936/3891
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Biological Response of the Corticision During Intrusion of Lower Incisors A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07514403
- Acronym / sponsor ID
- 936/3891
- Conditions
- Orthodontic Treatment Efficiency
- Keywords
- Orthodontics Malocclusion Corticision
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
biological assesment during intrusion of lower incisors
Detailed description
Assessment of the biological response of the corticision during intrusion of lower incisors A prospective clinical study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controlled | No intervention | –without corticision |
| active group | Active comparator | Other: Corticisioncorticision group |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Systemic diseases affecting bone metabolism
- Previous orthodontic treatment
- Periodontal disease
- Smoking
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticision1. 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. | Other | active group |
Primary outcome
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.
2 secondary outcomes
Amount of lower incisor intrusion measured in millimeters (mm) using cone beam computed tomography (CBCT)
Time frame: 12 weeks
External apical root resorption measured in millimeters (mm) using cone beam computed tomography (CBCT)
Time frame: Time Frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramadan Yu Abu-shahba, professor study director
Al-Azhar University, Faculty of Dental Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Corticision in people with Orthodontic Treatment Efficiency, run by Al-Azhar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact alaa eldin elshahat shafay, post gradute student (+201016886788, alaaelshafay9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels measured by enzyme-linked immunosorbent assay (ELISA) (pg/mL) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.