Skeletal Class 3 Malocclusion Due to Maxillary DeficiencyMaxiProtrNCT04310267
Three Levels of Force Application for Maxillary Protraction
A study testing Petit typeface mask in people with Skeletal Class 3 Malocclusion Due to Maxillary Deficiency, run by Al-Azhar University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Skeletal Class 3 Malocclusion Due to Maxillary Deficiency
- What is being tested?
- Petit typeface mask
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2020to 14 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dentoskeletal Changes Concomitant With Different Three Levels of Force Application for Maxillary Protraction in Growing Orthodontic Patients With Class 3 Malocclusion
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.
Read the 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.
- Being tested
- Petit typeface mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Petit typeface maskDevice
Also called Hyrax expander, Head gear face-bow (Denturum)
(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.
| Study group | Role | What they receive |
|---|---|---|
| classic occlusal level, low point of force application | Active comparator | the point of force application for maxillary protraction is at the level of the occlusal plane. Receives: Device: Petit typeface mask |
| Nasal level, Medium point of force application | Active comparator | the point of force application for maxillary protraction is at 20 mm from the occlusal plane (Nasal floor). Receives: Device: Petit typeface mask |
| Infrorbital level, High level | Active comparator | the point of force application for maxillary protraction is at the level of the infraorbital foramen Receives: Device: Petit typeface mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of maxillary advancement
the increase in maxillary length (condalyon-A point) in mm using Cone Beam Computed Tomgraphy (CBCT)
Measured: 8 months
Secondary outcomes (1)
degree of maxillary rotation
the change in maxillary inclination (occlusal plane to SN line) in degrees using Cone Beam Computed Tomgraphy (CBCT)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start5 Jun 2020
- Primary completion20 Aug 2021
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Class 3 Malocclusion Due to Maxillary DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled Mohammad Taha, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310267
- Sponsor's protocol ID
- 345KH
- Acronym
- MaxiProtr
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2020
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentoskeletal Changes Concomitant With Different Three Levels of Force Application for Maxillary Protraction in Growing Orthodontic Patients With Class 3 Malocclusion
- ClinicalTrials.gov ID
- NCT04310267
- Acronym / sponsor ID
- MaxiProtr / 345KH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| classic occlusal level, low point of force application | Active comparator | Device: Petit typeface maskthe point of force application for maxillary protraction is at the level of the occlusal plane. |
| Nasal level, Medium point of force application | Active comparator | Device: Petit typeface maskthe point of force application for maxillary protraction is at 20 mm from the occlusal plane (Nasal floor). |
| Infrorbital level, High level | Active comparator | Device: Petit typeface maskthe point of force application for maxillary protraction is at the level of the infraorbital foramen |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Petit typeface maskAlso: Hyrax expander, Head gear face-bow (Denturum)(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. | Device | Infrorbital level, High level, Nasal level, Medium point of force application, classic occlusal level, low point of force application |
Primary outcome
Amount of maxillary advancement
Time frame: 8 months
the increase in maxillary length (condalyon-A point) in mm using Cone Beam Computed Tomgraphy (CBCT)
1 secondary outcome
degree of maxillary rotation
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Petit typeface mask in people with Skeletal Class 3 Malocclusion Due to Maxillary Deficiency, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of maxillary advancement (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.