Effect of Extraction Vs Non-extraction Orthodontic Treatment on Vertical Facial Dimension
Primary Purpose
Malocclusion, Long Face Syndrome, Crowding, Tooth
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Extraction orthodontic treatment
Non-extraction orthodontic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring orthodontics, vertical dimension, premolars extraction, long face
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.
Sites / Locations
- Hasan HasanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Extraction orthodontic treatment
Non-extraction orthodontic treatment
Arm Description
orthodontic treatment with teeth extraction
non-extraction orthodontic treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in Overbite
Distances in millimeters will be measure directly in patient mouth by using caliper it will be measured in millimeters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04151875
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
July 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Long Face Syndrome, Crowding, Tooth
Keywords
orthodontics, vertical dimension, premolars extraction, long face
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
the outcome assessor will be masked about the group of the participant during the measuring the outcome ..
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extraction orthodontic treatment
Arm Type
Experimental
Arm Description
orthodontic treatment with teeth extraction
Arm Title
Non-extraction orthodontic treatment
Arm Type
Active Comparator
Arm Description
non-extraction orthodontic treatment
Intervention Type
Device
Intervention Name(s)
Extraction orthodontic treatment
Other Intervention Name(s)
Braces with teeth extraction
Intervention Description
orthodontic treatment with teeth extraction
Intervention Type
Device
Intervention Name(s)
Non-extraction orthodontic treatment
Other Intervention Name(s)
Braces with no extraction of teeth
Intervention Description
Non-extraction orthodontic treatment
Primary Outcome Measure Information:
Title
Changes in Vertical Dimension (VD)
Description
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
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
Secondary Outcome Measure Information:
Title
Changes in Overbite
Description
Distances in millimeters will be measure directly in patient mouth by using caliper it will be measured in millimeters.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan A Alrubaie, MSc
Phone
+201124777315
Email
hasan.naji@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amira A Aboulnaga, PhD ortho
Phone
+201000505688
Email
amira_aboalnaga@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan A Alrubaie, MSc
Organizational Affiliation
Orthodontic department, Faculty of Dentistry, Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amira A Aboulnaga, PhD
Organizational Affiliation
Orthodontic department, Faculty of Dentistry, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mai H Aboulfotouh, PhD
Organizational Affiliation
Orthodontic department, Faculty of Dentistry, Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amr E El dakroury, Prof.
Organizational Affiliation
Orthodontic department, Faculty of Dentistry, Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Hasan Hasan
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hasan a Hasan, MSc
Phone
01124777315
Email
Hasandentg@gmail.com
First Name & Middle Initial & Last Name & Degree
amira a aboalnaga, PhD
Email
amira_aboalnaga@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
it will be shareable for any researcher
IPD Sharing Time Frame
within month it will be ready
IPD Sharing Access Criteria
no special criteria..any orthodontic researcher can access the data
Learn more about this trial
Effect of Extraction Vs Non-extraction Orthodontic Treatment on Vertical Facial Dimension
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