Effect of Extraction Vs Non-extraction Orthodontic Treatment on Vertical Facial Dimension

Malocclusion Clinical Trial

Official title:

Effect of Extraction Versus Non-extraction Orthodontic Treatment on Vertical Facial Dimension: A Non-Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151875
• Other study ID #: ORTH 3-3-4 CU
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Hasan A Alrubaie, MSc
• Phone: +201124777315
• Email: hasan.naji[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 15, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crowding, Tooth
• Long Face Syndrome
• Malocclusion

Intervention

Device:
• Extraction orthodontic treatment
orthodontic treatment with teeth extraction
• Non-extraction orthodontic treatment
Non-extraction orthodontic treatment

Locations

Country	Name	City	State
Egypt	Hasan Hasan	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Changes in Overbite	Distances in millimeters will be measure directly in patient mouth by using caliper it will be measured in millimeters.	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