Back to resultsThree Levels of Force Application for Maxillary Protraction (MaxiProtr)
Primary Purpose
Skeletal Class 3 Malocclusion Due to Maxillary Deficiency
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Petit typeface mask
Sponsored by
About this trial
This is an interventional treatment trial for Skeletal Class 3 Malocclusion Due to Maxillary Deficiency
Eligibility Criteria
Inclusion criteria:
The patients will be included in the study if they have the following:
- An age range from 7 to 10 years.
- Patients diagnosed to have skeletal class 3 malocclusion due to retruded maxilla and/or combined maxillary retrusion with mild mandibular protrusion. (based on cephalometric analysis)
- No serious systemic diseases and/or medical treatment that could interfere with orthodontic tooth movement such as analgesics, non-steroidal anti-inflammatory drugs, and hormone supplements or antibiotics.
- Good oral hygiene and periodontal conditions.
- No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunctions.
- No previous orthodontic or orthognathic treatment.
Exclusion criteria:
The patients will be excluded from the study if they have the following:
- Systemic diseases or medications that could interfere with orthodontic treatment.
- Poor oral hygiene or periodontally compromised patients.
- Craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
- Previous orthodontic treatment.
Sites / Locations
- Alazhar University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
classic occlusal level, low point of force application
Nasal level, Medium point of force application
Infrorbital level, High level
Arm Description
the point of force application for maxillary protraction is at the level of the occlusal plane.
the point of force application for maxillary protraction is at 20 mm from the occlusal plane (Nasal floor).
the point of force application for maxillary protraction is at the level of the infraorbital foramen
Outcomes
Primary Outcome Measures
Amount of maxillary advancement
the increase in maxillary length (condalyon-A point) in mm using Cone Beam Computed Tomgraphy (CBCT)
Secondary Outcome Measures
degree of maxillary rotation
the change in maxillary inclination (occlusal plane to SN line) in degrees using Cone Beam Computed Tomgraphy (CBCT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04310267
Brief Title
Three Levels of Force Application for Maxillary Protraction
Acronym
MaxiProtr
Official Title
Dentoskeletal Changes Concomitant With Different Three Levels of Force Application for Maxillary Protraction in Growing Orthodontic Patients With Class 3 Malocclusion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
March 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate dentoskeletal changes concomitant with different three levels of force application for maxillary protraction in growing patients with skeletal class 3 malocclusion.
Detailed Description
Nanda reported that numerous experimental studies on primates have shown orthopedic changes in response to extraoral forces; however, very few studies have made an attempt to analyze the different force variables and their relationship to facial sutures. In consideration of the variables, experimental and clinical studies were initiated in their laboratory in 1972. A study on protraction of midfacial bones on primates reported that the point of force application significantly influences the center of rotation of the maxilla in rhesus monkeys. Our unpublished data also show that centers of rotation are influenced by the magnitude of force. The study showed that the maxilla can be successfully protracted by means of carefully controlled forces.
Based on the aforementioned data, we can hypothesize that the point of force application for maxillary protraction in relation to the center of resistance of maxilla could be utilized in order to correct skeletal class 3 malocclusions with different vertical dimension discrepancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skeletal Class 3 Malocclusion Due to Maxillary Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
classic occlusal level, low point of force application
Arm Type
Active Comparator
Arm Description
the point of force application for maxillary protraction is at the level of the occlusal plane.
Arm Title
Nasal level, Medium point of force application
Arm Type
Active Comparator
Arm Description
the point of force application for maxillary protraction is at 20 mm from the occlusal plane (Nasal floor).
Arm Title
Infrorbital level, High level
Arm Type
Active Comparator
Arm Description
the point of force application for maxillary protraction is at the level of the infraorbital foramen
Intervention Type
Device
Intervention Name(s)
Petit typeface mask
Other Intervention Name(s)
Hyrax expander, Head gear face-bow (Denturum)
Intervention Description
(Intraoral) Hyrax expander for maxilary sutures disarticulation through expansion, (Extraoral) Face mask for generating maxillary protraction forces and head gear face-bow to act as a connector between both intra and extra oral parts.
Primary Outcome Measure Information:
Title
Amount of maxillary advancement
Description
the increase in maxillary length (condalyon-A point) in mm using Cone Beam Computed Tomgraphy (CBCT)
Time Frame
8 months
Secondary Outcome Measure Information:
Title
degree of maxillary rotation
Description
the change in maxillary inclination (occlusal plane to SN line) in degrees using Cone Beam Computed Tomgraphy (CBCT)
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
The patients will be included in the study if they have the following:
An age range from 7 to 10 years.
Patients diagnosed to have skeletal class 3 malocclusion due to retruded maxilla and/or combined maxillary retrusion with mild mandibular protrusion. (based on cephalometric analysis)
No serious systemic diseases and/or medical treatment that could interfere with orthodontic tooth movement such as analgesics, non-steroidal anti-inflammatory drugs, and hormone supplements or antibiotics.
Good oral hygiene and periodontal conditions.
No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunctions.
No previous orthodontic or orthognathic treatment.
Exclusion criteria:
The patients will be excluded from the study if they have the following:
Systemic diseases or medications that could interfere with orthodontic treatment.
Poor oral hygiene or periodontally compromised patients.
Craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
Previous orthodontic treatment.
Facility Information:
Facility Name
Alazhar University
City
Cairo
ZIP/Postal Code
3511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Three Levels of Force Application for Maxillary Protraction
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