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

NCT04151875 | Unknown

• 1 other identifier: ORTH 3-3-4 CU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Long Face Syndrome; Crowding, Tooth

Keywords

orthodontics; vertical dimension; premolars extraction; long face

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Overbite

  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

Study Arms (2)

Extraction orthodontic treatment

EXPERIMENTAL

orthodontic treatment with teeth extraction

Device: Extraction orthodontic treatment

Non-extraction orthodontic treatment

ACTIVE COMPARATOR

non-extraction orthodontic treatment

Device: Non-extraction orthodontic treatment

Interventions

Extraction orthodontic treatment DEVICE

orthodontic treatment with teeth extraction

Also known as: Braces with teeth extraction

Extraction orthodontic treatment

Non-extraction orthodontic treatment DEVICE

Non-extraction orthodontic treatment

Also known as: Braces with no extraction of teeth

Non-extraction orthodontic treatment

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hasan Hasan

Cairo, 11559, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 41636882 DERIVED

MeSH Terms

Conditions

Malocclusion

Interventions

Braces; Tooth Extraction

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Hasan A Alrubaie, MSc

  Orthodontic department, Faculty of Dentistry, Cairo University

  PRINCIPAL INVESTIGATOR

• Amira A Aboulnaga, PhD

  Orthodontic department, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Mai H Aboulfotouh, PhD

  Orthodontic department, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Amr E El dakroury, Prof.

  Orthodontic department, Faculty of Dentistry, Cairo University

  STUDY CHAIR

Central Study Contacts

Hasan A Alrubaie, MSc

CONTACT

+201124777315; hasan.naji@dentistry.cu.edu.eg

Amira A Aboulnaga, PhD ortho

CONTACT

+201000505688; amira_aboalnaga@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the outcome assessor will be masked about the group of the participant during the measuring the outcome ..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: -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.

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: November 5, 2019
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 15, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: within month it will be ready
• Access Criteria: no special criteria..any orthodontic researcher can access the data

Locations

EG (1)