MalocclusionNCT04151875
Effect of Extraction Vs Non-extraction Orthodontic Treatment on Vertical Facial Dimension
A study testing Extraction orthodontic treatment and Non-extraction orthodontic treatment in people with Malocclusion and Long Face Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the current clinical trial was to evaluate the effects of premolar extractions compared with non-extraction orthodontic treatment on the skeletal vertical dimension of the face. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Long Face Syndrome, Crowding, Tooth
- What is being tested?
- Extraction orthodontic treatment and Non-extraction orthodontic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normodivergent and hyperdivergent patients
- Cases with moderate crowding.
- Borderline cases which could be treated with extraction or non-extraction strategies
Who cannot join
- Hypodivergent patients.
- Cases with extremely sever crowding.
- Patients with high caries index or periodontal problems.
- Patients with systemic diseases, or syndromic conditions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hasan Hasan
Cairo, 11559
Hasan a Hasan, MSc, 01124777315, Hasandentg@gmail.com
amira a aboalnaga, PhD, amira_aboalnaga@dentistry.cu.edu.eg
About this study
Official title: Effect of Extraction Versus Non-extraction Orthodontic Treatment on Vertical Facial Dimension: A Non-Randomized Clinical Trial
The aim of the current clinical trial was to evaluate the effects of premolar extractions compared with non-extraction orthodontic treatment on the skeletal vertical dimension of the face.
The null-hypothesis is that there is no difference in post-treatment skeletal vertical characteristics of normodivergent and hyperdivergent patients treated orthodontically with first premolar extractions compared with patients treated in non-extraction manner.
Read the detailed description
The current protocol will be submitted for partial fulfillment of the PhD requirements in Faculty of Dentistry, Cairo University.
The trial will be conducted in the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.
Primary examination and diagnosis of the patients seeking orthodontic treatment will be performed, to select a sample of the trial.
then, final diagnosis and planing of each participant will be performed by a trained orthodontists to be sure that all patients fallen with the inclusion criteria.
Interventions will be conducted with the same orthodontist, under supervision of orthodontic professors in the Orthodontic department, Cairo University.
- Conditions
- Malocclusion, Long Face Syndrome, Crowding, Tooth
- Being tested
- Extraction orthodontic treatment, Non-extraction orthodontic treatment
- Keywords
- orthodontics, vertical dimension, premolars extraction, long face
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction orthodontic treatmentDevice
Also called Braces with teeth extraction
orthodontic treatment with teeth extraction
Non-extraction orthodontic treatmentDevice
Also called Braces with no extraction of teeth
Non-extraction orthodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Extraction orthodontic treatment | Experimental | orthodontic treatment with teeth extraction Receives: Device: Extraction orthodontic treatment |
| Non-extraction orthodontic treatment | Active comparator | non-extraction orthodontic treatment Receives: Device: Non-extraction orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Vertical Dimension (VD)
Vertical dimension of the face will be assessed by measuring a distances in millimeters between vertical points as ANS-Me (lower facial height), also it will be measured form angles in a degrees as angle SN/MP
Measured: after 1year. Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention
Secondary outcomes (1)
Changes in Overbite
Distances in millimeters will be measure directly in patient mouth by using caliper it will be measured in millimeters.
Measured: 1 year . Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Jun 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- -Interventions Intervention Group (I) Extraction treatment group. Bonding all cases will be performed by the principal investigator, then premolars extraction will be done, then installing the 1st alignment wire. Comparator group (C): Non-extraction group. Same orthodontist will bond all the cases and install the 1st alignment wire.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Abdullah Naji Hasan, Cairo University
- Investigators
- Hasan A Alrubaie, MSc, Principal investigator, Orthodontic department, Faculty of Dentistry, Cairo UniversityAmira A Aboulnaga, PhD, Study director, Orthodontic department, Faculty of Dentistry, Cairo UniversityMai H Aboulfotouh, PhD, Study director, Orthodontic department, Faculty of Dentistry, Cairo UniversityAmr E El dakroury, Prof., Study chair, Orthodontic department, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151875
- Sponsor's protocol ID
- ORTH 3-3-4 CU
- Status last verified
- Mar 2022
- First submitted
- 18 Oct 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be shareable for any researcher
Publications
Alrubaie HA, Aboalnaga AA, Alhammadi MS, Eldakroury AE, Aboulfotouh MH. Vertical skeletal dimension and dentoalveolar changes in extraction versus non-extraction orthodontic treatment in class I malocclusion: a non-randomized clinical trial. Clin Oral Investig. 2026 Feb 4;30(2):69. doi: 10.1007/s00784-026-06768-0.
PubMed 41636882
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extraction Versus Non-extraction Orthodontic Treatment on Vertical Facial Dimension: A Non-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04151875
- Acronym / sponsor ID
- ORTH 3-3-4 CU
- Conditions
- Malocclusion, Long Face Syndrome, Crowding, Tooth
- Keywords
- orthodontics, vertical dimension, premolars extraction, long face
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 5 Nov 2019 (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.
The aim of the current clinical trial was to evaluate the effects of premolar extractions compared with non-extraction orthodontic treatment on the skeletal vertical dimension of the face.
The null-hypothesis is that there is no difference in post-treatment skeletal vertical characteristics of normodivergent and hyperdivergent patients treated orthodontically with first premolar extractions compared with patients treated in non-extraction manner.
Detailed description
The current protocol will be submitted for partial fulfillment of the PhD requirements in Faculty of Dentistry, Cairo University.
The trial will be conducted in the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.
Primary examination and diagnosis of the patients seeking orthodontic treatment will be performed, to select a sample of the trial.
then, final diagnosis and planing of each participant will be performed by a trained orthodontists to be sure that all patients fallen with the inclusion criteria.
Interventions will be conducted with the same orthodontist, under supervision of orthodontic professors in the Orthodontic department, Cairo University.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- -Interventions Intervention Group (I) Extraction treatment group. Bonding all cases will be performed by the principal investigator, then premolars extraction will be done, then installing the 1st alignment wire. Comparator group (C): Non-extraction group. Same orthodontist will bond all the cases and install the 1st alignment wire.
| Arm | Type | Receives |
|---|---|---|
| Extraction orthodontic treatment | Experimental | Device: Extraction orthodontic treatmentorthodontic treatment with teeth extraction |
| Non-extraction orthodontic treatment | Active comparator | Device: Non-extraction orthodontic treatmentnon-extraction orthodontic treatment |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Normodivergent and hyperdivergent patients
- Cases with moderate crowding.
- Borderline cases which could be treated with extraction or non-extraction strategies
Key exclusion criteria (4 listed)
- Hypodivergent patients.
- Cases with extremely sever crowding.
- Patients with high caries index or periodontal problems.
- Patients with systemic diseases, or syndromic conditions.
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 |
|---|---|---|
| Extraction orthodontic treatmentAlso: Braces with teeth extractionorthodontic treatment with teeth extraction | Device | Extraction orthodontic treatment |
| Non-extraction orthodontic treatmentAlso: Braces with no extraction of teethNon-extraction orthodontic treatment | Device | Non-extraction orthodontic treatment |
Primary outcome
Changes in Vertical Dimension (VD)
Time frame: after 1year. Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention
Vertical dimension of the face will be assessed by measuring a distances in millimeters between vertical points as ANS-Me (lower facial height), also it will be measured form angles in a degrees as angle SN/MP
1 secondary outcome
Changes in Overbite
Time frame: 1 year . Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 41636882Alrubaie HA, Aboalnaga AA, Alhammadi MS, Eldakroury AE, Aboulfotouh MH. Vertical skeletal dimension and dentoalveolar changes in extraction versus non-extraction orthodontic treatment in class I malocclusion: a non-randomized clinical trial. Clin Oral Investig. 2026 Feb 4;30(2):69. doi: 10.1007/s00784-026-06768-0.
- Individual participant dataSharing planned: Yes. it will be shareable for any researcher
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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. This study is not recruiting at the moment.
Hasan A Alrubaie, MSc principal investigator
Orthodontic department, Faculty of Dentistry, Cairo University
Amira A Aboulnaga, PhD study director
Orthodontic department, Faculty of Dentistry, Cairo University
Mai H Aboulfotouh, PhD study director
Orthodontic department, Faculty of Dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraction orthodontic treatment and Non-extraction orthodontic treatment in people with Malocclusion and Long Face Syndrome, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hasan A Alrubaie, MSc (+201124777315, hasan.naji@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Vertical Dimension (VD) (time frame: after 1year. Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151875, which also lists 1 linked publication.
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 7 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.