Three Levels of Force Application for Maxillary Protraction

Not Applicable

Completed

• Conditions: Skeletal Class 3 Malocclusion Due to Maxillary Deficiency
• Interventions: Device: Petit typeface mask

• Registration Number: NCT04310267
• Lead Sponsor: Al-Azhar University

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 Our unpublished data also show that centers of rotation are influenced by the magnitude of force.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.

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-17
• Study Start: 2020-06-05
• Primary Completion: 2021-08-20
• Study Completion: 2022-03-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-20
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal level, Medium point of force application	Petit typeface mask	the point of force application for maxillary protraction is at 20 mm from the occlusal plane (Nasal floor).
classic occlusal level, low point of force application	Petit typeface mask	the point of force application for maxillary protraction is at the level of the occlusal plane.
Infrorbital level, High level	Petit typeface mask	the point of force application for maxillary protraction is at the level of the infraorbital foramen

Primary Outcome Measures

Name	Time	Method
Amount of maxillary advancement	8 months	the increase in maxillary length (condalyon-A point) in mm using Cone Beam Computed Tomgraphy (CBCT)

Secondary Outcome Measures

Name	Time	Method
degree of maxillary rotation	8 months	the change in maxillary inclination (occlusal plane to SN line) in degrees using Cone Beam Computed Tomgraphy (CBCT)

Trial Locations

Locations (1)

Alazhar University; 🇪🇬 Cairo, Egypt