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Three Levels of Force Application for Maxillary Protraction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04310267
Acronym
MaxiProtr
Enrollment
30
Registered
2020-03-17
Start date
2020-06-05
Completion date
2022-03-14
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skeletal Class 3 Malocclusion Due to Maxillary Deficiency

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 Our unpublished data also show that centers of rotation are influenced by the magnitude of force.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

Interventions

DEVICEPetit 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.

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of maxillary advancement8 monthsthe increase in maxillary length (condalyon-A point) in mm using Cone Beam Computed Tomgraphy (CBCT)

Secondary

MeasureTime frameDescription
degree of maxillary rotation8 monthsthe change in maxillary inclination (occlusal plane to SN line) in degrees using Cone Beam Computed Tomgraphy (CBCT)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026