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Completed

NCT Number: NCT04310267

Three Levels of Force Application for Maxillary Protraction

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.

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Key information

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alazhar University

Cairo, 3511, Egypt

About this study

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 Our unpublished data also show that centers of rotation are influenced by the magnitude of force.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Petit typeface mask

Device

(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.

Other names: Hyrax expander, Head gear face-bow (Denturum)

Primary outcomes

  1. Amount of maxillary advancement

    Time frame: 8 months

    the increase in maxillary length (condalyon-A point) in mm using Cone Beam Computed Tomgraphy (CBCT)

Secondary outcomes

  1. degree of maxillary rotation

    Time frame: 8 months

    the change in maxillary inclination (occlusal plane to SN line) in degrees using Cone Beam Computed Tomgraphy (CBCT)

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: MaxiProtr

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 17, 2020
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.