Three Levels of Force Application for Maxillary Protraction

Skeletal Class 3 Malocclusion Due to Maxillary Deficiency Clinical Trial

— MaxiProtr  

Official title:

Dentoskeletal Changes Concomitant With Different Three Levels of Force Application for Maxillary Protraction in Growing Orthodontic Patients With Class 3 Malocclusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310267
• Other study ID #: 345KH
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: March 14, 2022

Study information

• Verified date: July 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Our unpublished data also show that centers of rotation are influenced by the magnitude of force.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 14, 2022
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

Inclusion criteria:

The patients will be included in the study if they have the following:

1. An age range from 7 to 10 years.

2. 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)

3. 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.

4. Good oral hygiene and periodontal conditions.

5. No evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunctions.

6. No previous orthodontic or orthognathic treatment.

Exclusion criteria:

The patients will be excluded from the study if they have the following:

1. Systemic diseases or medications that could interfere with orthodontic treatment.

2. Poor oral hygiene or periodontally compromised patients.

3. Craniofacial anomalies or previous history of trauma, bruxism or parafunctions.

4. Previous orthodontic treatment.

Related Conditions & MeSH terms

• Malocclusion
• Skeletal Class 3 Malocclusion Due to Maxillary Deficiency

Intervention

Device:
• Petit typeface mask
(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.

Locations

Country	Name	City	State
Egypt	Alazhar University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of maxillary advancement	the increase in maxillary length (condalyon-A point) in mm using Cone Beam Computed Tomgraphy (CBCT)	8 months
Secondary	degree of maxillary rotation	the change in maxillary inclination (occlusal plane to SN line) in degrees using Cone Beam Computed Tomgraphy (CBCT)	8 months