Maxillary Protraction in Class III Adolescent After Using (MSE)NCT05489302
Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE)
A study testing Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol. and Maxillary skeletal expander with protraction face mask with conventional protocol in people with Maxillary Protraction in Class III Adolescent After Using (MSE), run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study of this study is to compare two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion using cone beam computed tomography (CBCT) Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Protraction in Class III Adolescent After Using (MSE)
- What is being tested?
- Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol. and Maxillary skeletal expander with protraction face mask with conventional protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2022to 20 Dec 2023
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Class3 Patients suffering maxillary collapse with a skeletal background
- Patients with retrognathic maxilla.
- Patients with anterior cross-bite or incisor end-to-end relationship
- Patients with unilateral or bilateral posterior crossbite.
- Patients with no periodontal disease.
- Patients with good oral hygiene and general health.
- No systemic diseases that may affect bone quality or interfere with orthodontic treatment.
- Patients with no previous orthodontic treatment.
Who cannot join
- previous orthodontic treatment.
- Craniofacial syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE) Alt-RAMEC vs Conventional Rapid Palatal Expansion Randomized Controlled Trial -CBCT Study
The aim of this study of this study is to compare two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion using cone beam computed tomography (CBCT)
- Being tested
- Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol., Maxillary skeletal expander with protraction face mask with conventional protocol
- Keywords
- Expansion, maxillary protraction, class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol.Device
The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by Alt-RAMEC protocol.
Maxillary skeletal expander with protraction face mask with conventional protocolDevice
The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by conventional protocol
| Study group | Role | What they receive |
|---|---|---|
| (MSE) Alt-RAMEC protocol | Active comparator | Not described Receives: Device: Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol. |
| (MSE) conventional protocol | Active comparator | Not described Receives: Device: Maxillary skeletal expander with protraction face mask with conventional protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of maxillary protraction
protraction of maxilla using CBCT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start20 Jun 2022
- Primary completion30 Dec 2022
- Study completion20 Dec 2023 (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 Protraction in Class III Adolescent After Using (MSE)Studies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelrhman Shendy Abdelrhman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489302
- Sponsor's protocol ID
- 828/220
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Evaluation of two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion
Publications
Liou EJ, Tsai WC. A new protocol for maxillary protraction in cleft patients: repetitive weekly protocol of alternate rapid maxillary expansions and constrictions. Cleft Palate Craniofac J. 2005 Mar;42(2):121-7. doi: 10.1597/03-107.1.
PubMed 15748102
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE) Alt-RAMEC vs Conventional Rapid Palatal Expansion Randomized Controlled Trial -CBCT Study
- ClinicalTrials.gov ID
- NCT05489302
- Acronym / sponsor ID
- 828/220
- Keywords
- Expansion, maxillary protraction, class III
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 5 Aug 2022 (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 of this study is to compare two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion using cone beam computed tomography (CBCT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (MSE) Alt-RAMEC protocol | Active comparator | Device: Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol. |
| (MSE) conventional protocol | Active comparator | Device: Maxillary skeletal expander with protraction face mask with conventional protocol |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Class3 Patients suffering maxillary collapse with a skeletal background
- Patients with retrognathic maxilla.
- Patients with anterior cross-bite or incisor end-to-end relationship
- Patients with unilateral or bilateral posterior crossbite.
- Patients with no periodontal disease.
Key exclusion criteria (2 listed)
- previous orthodontic treatment.
- Craniofacial syndrome.
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 skeletal expander with protraction face mask with Alt-RAMEC protocol.The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by Alt-RAMEC protocol. | Device | (MSE) Alt-RAMEC protocol |
| Maxillary skeletal expander with protraction face mask with conventional protocolThe current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by conventional protocol | Device | (MSE) conventional protocol |
Primary outcome
amount of maxillary protraction
Time frame: 6 months
protraction of maxilla using CBCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Background: PubMed 15748102Liou EJ, Tsai WC. A new protocol for maxillary protraction in cleft patients: repetitive weekly protocol of alternate rapid maxillary expansions and constrictions. Cleft Palate Craniofac J. 2005 Mar;42(2):121-7. doi: 10.1597/03-107.1.
- Individual participant dataSharing planned: No. Evaluation of two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion
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 Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol. and Maxillary skeletal expander with protraction face mask with conventional protocol in people with Maxillary Protraction in Class III Adolescent After Using (MSE), 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 8 inclusion and 2 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 18 Aug 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?
Results are not available in the source record.
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 protraction (time frame: 6 months). 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 NCT05489302, 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 18 Aug 2023.