Three Levels of Force Application for Maxillary Protraction

NCT ID: NCT04310267

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-05
• Study Completion Date: 2022-03-14

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 Our unpublished data also show that centers of rotation are influenced by the magnitude of force.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

Conditions

Skeletal Class 3 Malocclusion Due to Maxillary Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

classic occlusal level, low point of force application

the point of force application for maxillary protraction is at the level of the occlusal plane.

Group Type: ACTIVE_COMPARATOR

Petit typeface mask

Intervention Type: 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.

Nasal level, Medium point of force application

the point of force application for maxillary protraction is at 20 mm from the occlusal plane (Nasal floor).

Group Type: ACTIVE_COMPARATOR

Petit typeface mask

Intervention Type: 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.

Infrorbital level, High level

the point of force application for maxillary protraction is at the level of the infraorbital foramen

Group Type: ACTIVE_COMPARATOR

Petit typeface mask

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Hyrax expander, Head gear face-bow (Denturum)

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

khaled Mohammad Taha

lecturer of orthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alazhar University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

345KH

Identifier Type: -

Identifier Source: org_study_id