Clinical trial NCT04151875: Effect of Extraction Vs Non-extraction Orthodontic Treatment on Vertical Facial Dimension
Official title: Effect of Extraction Versus Non-extraction Orthodontic Treatment on Vertical Facial Dimension: A Non-Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Long Face Syndrome
Crowding, Tooth
Keywords: orthodontics
vertical dimension
premolars extraction
long face
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Normodivergent and hyperdivergent patients
* Cases with moderate crowding.
* Borderline cases which could be treated with extraction or non-extraction strategies

Exclusion Criteria:

* Hypodivergent patients.
* Cases with extremely sever crowding.
* Patients with high caries index or periodontal problems.
* Patients with systemic diseases, or syndromic conditions.

Primary outcomes:
measure: Changes in Vertical Dimension (VD)
timeFrame: 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:
measure: Changes in Overbite
timeFrame: 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
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hasan Hasan
Study officials:
affiliation: Orthodontic department, Faculty of Dentistry, Cairo University
name: Hasan A Alrubaie, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthodontic department, Faculty of Dentistry, Cairo University
name: Amira A Aboulnaga, PhD
role: STUDY_DIRECTOR
affiliation: Orthodontic department, Faculty of Dentistry, Cairo University
name: Mai H Aboulfotouh, PhD
role: STUDY_DIRECTOR
affiliation: Orthodontic department, Faculty of Dentistry, Cairo University
name: Amr E El dakroury, Prof.
role: STUDY_CHAIR
References: