Maxillary DeficiencyNCT05089396
Effects of Conventional Versus Skeletally Anchored Facemask in Treatment of the Prepubertal Skeletal Class III Patients
A study testing Maxillary protraction in people with Maxillary Deficiency and Maxillary Retrusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study will be directed to the assessment of dentoskeletal effects concomitant with skeletally anchored maxillary protraction in orthodontic skeletal Class III patients. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Deficiency, Maxillary Retrusion
- What is being tested?
- Maxillary protraction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2021to Oct 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Growing Class III patients with a prepubertal stage of skeletal maturity according to the cervical vertebral maturation method.
- Skeletal Class III malocclusion with maxillary deficiency (ANB, <0°; N perp-A<1mm) with or without mild mandibular prognathism.
- Late mixed or early permanent dentition at the start of treatment characterized by a Wits appraisal of -1 mm or less and an Angle Class III molar relationship or anterior crossbite.
- Vertically normal growth pattern determined by cephalometric radiographs.
- Patients are free from developmental or congenital conditions such as cleft lip/palate or other craniofacial anomalies.
- No previous orthodontic treatment.
Who cannot join
- Poor oral hygiene or periodontally compromised patient.
- Patients with craniofacial anomalies or previous history of trauma, bruxism, or parafunctions.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Al-azhar university- Faculty of Dental Medicine
Cairo
About this study
Official title: Assessment of Dentoskeletal Effects Concomitant With Skeletally Anchored Maxillary Protraction in Orthodontic Skeletal Class III Patients
The aim of this study will be directed to the assessment of dentoskeletal effects concomitant with skeletally anchored maxillary protraction in orthodontic skeletal Class III patients.
Read the detailed description
Skeletal Class III is a challenging problem that is confronting orthodontists in their everyday orthodontic practice. The prevalence of this malocclusion varies globally among and within populations with the greatest incidence among Asian countries. It was reported that Class III malocclusion represents 3.98% and 5.93% of malocclusions in mixed and permanent dentitions respectively. Among Egyptians, the prevalence of Class III malocclusion during mixed dentition was found to be 5.9 % according to the sample studied by Fsifis et al.
Different skeletal components contribute to the development of the classic Class III with convex or straight profiles. These components are either maxillary retrognathism, mandibular prognathism relative to other craniofacial structures, or even a combination of them. According to the sample studied by Ellis and Macnamara, they found 65% to 67% of skeletal Class III was due to maxillary skeletal retrusion.
The growth and severity of the sagittal skeletal discrepancy dictate the possible treatment modalities. On one hand, Growth modification is indicated in individuals who have not reached the growth spurt yet. On the other hand, cessation of growth leaves only orthodontic camouflage and orthognathic surgery as treatment options, the severity of the anteroposterior discrepancy and dental compensation determine which of them gives the best clinical results.
The most common approach for the treatment of growing Class III patients with maxillary retrognathism is the facemask (FM) accompanied by rapid maxillary expansion (RME). RME was claimed to open the midpalatal suture and affect the other nine sutures adjacent to the maxilla. Accordingly, it is said to facilitate the orthopedic effect of the facemask. However, a meta-analysis concluded that treatment with facemask with or without RME is clinically effective with a nonsignificant difference.
Forces from protraction facemask are applied to dental structures so, it has side effects as mesial movement and extrusion of maxillary molars, proclination of upper incisors, retroclination of mandibular incisors, backward rotation of the mandible, and increase in the lower facial height. These side effects might be desirable or undesirable according to the clinical situation.
Maximizing skeletal effects and minimizing dental effects will reduce the tendency for relapse and might be a desirable clinical outcome. For this purpose, in 1985 Kokich et al used ankylosed canines as a form of absolute anchorage for maxillary protraction. The advent of temporary anchorage devices (TADs) led to many reports with skeletally anchored maxillary protraction, Singer et al, Enacar et al, Hong et al, and Kircelli et al.
This was followed by several studies applying facemask to miniplates at the zygomatic buttress, lateral nasal wall, and miniscrews (MS) in the zygomatic buttress, or in the palate. Consequently, the present study will be directed to evaluate the effects of skeletally anchored maxillary protraction.
- Conditions
- Maxillary Deficiency, Maxillary Retrusion
- Being tested
- Maxillary protraction
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary protractionOther
A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in the active comparator group. in the experimental group, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. in both groups, a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side.
| Study group | Role | What they receive |
|---|---|---|
| conventional dentally anchored maxillary protraction | Active comparator | A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch). a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side. Receives: Other: Maxillary protraction |
| skeletally anchored maxillary protraction | Experimental | A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in addition, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side. Receives: Other: Maxillary protraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
midfacial length
linear distance between condylon and A points
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start22 Nov 2021
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary DeficiencyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Gouda Embaby, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089396
- Sponsor's protocol ID
- SA maxillary protraction
- Status last verified
- Nov 2021
- First submitted
- 11 Oct 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seiryu M, Ida H, Mayama A, Sasaki S, Sasaki S, Deguchi T, Takano-Yamamoto T. A comparative assessment of orthodontic treatment outcomes of mild skeletal Class III malocclusion between facemask and facemask in combination with a miniscrew for anchorage in growing patients: A single-center, prospective randomized controlled trial. Angle Orthod. 2020 Jan;90(1):3-12. doi: 10.2319/101718-750.1. Epub 2019 Aug 12.
PubMed 31398066
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dentoskeletal Effects Concomitant With Skeletally Anchored Maxillary Protraction in Orthodontic Skeletal Class III Patients
- ClinicalTrials.gov ID
- NCT05089396
- Acronym / sponsor ID
- SA maxillary protraction
- Conditions
- Maxillary Deficiency, Maxillary Retrusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 Oct 2021 (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 will be directed to the assessment of dentoskeletal effects concomitant with skeletally anchored maxillary protraction in orthodontic skeletal Class III patients.
Detailed description
Skeletal Class III is a challenging problem that is confronting orthodontists in their everyday orthodontic practice. The prevalence of this malocclusion varies globally among and within populations with the greatest incidence among Asian countries. It was reported that Class III malocclusion represents 3.98% and 5.93% of malocclusions in mixed and permanent dentitions respectively. Among Egyptians, the prevalence of Class III malocclusion during mixed dentition was found to be 5.9 % according to the sample studied by Fsifis et al.
Different skeletal components contribute to the development of the classic Class III with convex or straight profiles. These components are either maxillary retrognathism, mandibular prognathism relative to other craniofacial structures, or even a combination of them. According to the sample studied by Ellis and Macnamara, they found 65% to 67% of skeletal Class III was due to maxillary skeletal retrusion.
The growth and severity of the sagittal skeletal discrepancy dictate the possible treatment modalities. On one hand, Growth modification is indicated in individuals who have not reached the growth spurt yet. On the other hand, cessation of growth leaves only orthodontic camouflage and orthognathic surgery as treatment options, the severity of the anteroposterior discrepancy and dental compensation determine which of them gives the best clinical results.
The most common approach for the treatment of growing Class III patients with maxillary retrognathism is the facemask (FM) accompanied by rapid maxillary expansion (RME). RME was claimed to open the midpalatal suture and affect the other nine sutures adjacent to the maxilla. Accordingly, it is said to facilitate the orthopedic effect of the facemask. However, a meta-analysis concluded that treatment with facemask with or without RME is clinically effective with a nonsignificant difference.
Forces from protraction facemask are applied to dental structures so, it has side effects as mesial movement and extrusion of maxillary molars, proclination of upper incisors, retroclination of mandibular incisors, backward rotation of the mandible, and increase in the lower facial height. These side effects might be desirable or undesirable according to the clinical situation.
Maximizing skeletal effects and minimizing dental effects will reduce the tendency for relapse and might be a desirable clinical outcome. For this purpose, in 1985 Kokich et al used ankylosed canines as a form of absolute anchorage for maxillary protraction. The advent of temporary anchorage devices (TADs) led to many reports with skeletally anchored maxillary protraction, Singer et al, Enacar et al, Hong et al, and Kircelli et al.
This was followed by several studies applying facemask to miniplates at the zygomatic buttress, lateral nasal wall, and miniscrews (MS) in the zygomatic buttress, or in the palate. Consequently, the present study will be directed to evaluate the effects of skeletally anchored maxillary protraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional dentally anchored maxillary protraction | Active comparator | Other: Maxillary protractionA petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch). a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side. |
| skeletally anchored maxillary protraction | Experimental | Other: Maxillary protractionA petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in addition, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Growing Class III patients with a prepubertal stage of skeletal maturity according to the cervical vertebral maturation method.
- Skeletal Class III malocclusion with maxillary deficiency (ANB, <0°; N perp-A<1mm) with or without mild mandibular prognathism.
- Late mixed or early permanent dentition at the start of treatment characterized by a Wits appraisal of -1 mm or less and an Angle Class III molar relationship or anterior crossbite.
- Vertically normal growth pattern determined by cephalometric radiographs.
- Patients are free from developmental or congenital conditions such as cleft lip/palate or other craniofacial anomalies.
Key exclusion criteria (3 listed)
- Poor oral hygiene or periodontally compromised patient.
- Patients with 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 |
|---|---|---|
| Maxillary protractionA petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in the active comparator group. in the experimental group, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. in both groups, a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side. | Other | conventional dentally anchored maxillary protraction, skeletally anchored maxillary protraction |
Primary outcome
midfacial length
Time frame: 1 year
linear distance between condylon and A points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Background: PubMed 31398066Seiryu M, Ida H, Mayama A, Sasaki S, Sasaki S, Deguchi T, Takano-Yamamoto T. A comparative assessment of orthodontic treatment outcomes of mild skeletal Class III malocclusion between facemask and facemask in combination with a miniscrew for anchorage in growing patients: A single-center, prospective randomized controlled trial. Angle Orthod. 2020 Jan;90(1):3-12. doi: 10.2319/101718-750.1. Epub 2019 Aug 12.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary protraction in people with Maxillary Deficiency and Maxillary Retrusion, 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Embaby, BDS (00201016579279, amrembaby.209@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
midfacial length (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05089396, which also lists 1 linked publication.
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 30 Nov 2021.