Maxillary AnomalyNCT06467240
Evaluation of the Hybrid Rapid Maxillary Expander Assisted With Micro-osteo Perforation (MOPs) in Adult.
An observational study of Maxillary Anomaly, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study will be directed for Evaluation of the hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs) in adults Read more about this study
- Who is it for?
- Ages 17 to 23 years
- Conditions the study is for
- Maxillary Anomaly
- What is being tested?
- hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs)
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 20 Aug 2025
- Phase
- Observational
- 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 17 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: randamly selected
Who may be able to join
- An age range from 17-23 years.
- Transverse maxillary deficiency.
- Maxillary lingual Cross bite (unilateral or bilateral)
- No history of previous orthodontic treatment.
- Good oral and general health.
- No systemic condition that could interfere with orthodontic treatment.
Who cannot join
- Patient with craniofacial anomalies .
- History of extraction of permanent teeth.
- Previous orthodontic treatment.
- Poor oral hygiene or periodontally compromised patient.
- Previous history of bruxism, trauma or par functions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Hybrid Rapid Maxillary Expander Assisted With Micro-osteo Perforation (MOPs) in Adults: A Prospective Clinical Study
This study will be directed for Evaluation of the hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs) in adults
Read the detailed description
Transverse maxillary deficiencies are common orthodontic issues observed by professionals. It is estimated that 9.4% of adult orthodontic patients have a transverse maxillary deficiency in combination with a posterior cross bite. A normal transverse skeletal relationship between basal bones is fundamental to achieving a satisfactory and stable occlusion.
Therefore, to correct a maxillary transverse deficiency, palatal expanders are needed. Since Haas popularized this technique in the early 1960s, rapid palatal expanders are the most popular devices of choice, characterized by safety, predictability and efficiency.
The rapid process of activation reduces dental movements (side effects) thus enabling skeletal expansion. Surprisingly, only 30% of the expander opening seems to result in suture opening, whereas one-third reflects alveolar bending and another 30% dental movement.
During activations of traditional tooth-borne rapid palatal expansion devices, heavy transverse forces are generated in a short period of time, causing disruption of the inter sutural tissue thus producing midpalatal suture opening.
On many occasions, these expansion forces in-vivo are in the range of 75-120 N, measured at the level of the hyrax screw of the connecting stainless-steel wire arms at the buccal crowns. In vitro skeletal hybrid expanders, before plastic deformation, demonstrated expansion force values from 67 ± 13 N to 183 ± 48 N when tested on the mini-implant's reinforced bone-anchored wire arms .With these forces, the opening of the palatal suture in adolescents or young adults can be frequently unsuccessful.
Therefore, conventional expanders, under high loads, deform prematurely or create excessive molar tipping or mucosa soreness before
reaching midpalatal suture opening. If these expansion forces are not able to open the suture, surgically assisted rapid palatal expansion (SARPE) is suggested.
In addition, scientific papers do not provide information of the amount of force at the level of the midpalatal suture and the limit of plastic deformation. Solely anchored on orthodontic mini-implants (OMIs) and placed in the anterior-middle palate. These bone anchored expanders seem to improve the aforementioned drawbacks and provide greater expansion forces to facilitate midpalatal suture opening even in adult patients so as to avoid SARPE.
Major areas of resistance to hybrid rapid maxillary expansion are mid palatine suture and the pterygomaxillary articulation. With increasing the age, the interdigitation at sutures increases making the site more rigid. The concept of regional acceleratory phenomenon (RAP) can be used for such clinical challenges by using mild surgical trauma induced by Micro-osteo perforation (MOPs) to produce localized inflammation with the mid palatine suture being the only sight easily accessible for intervention, minimally invasive procedures like Micro-osteo perforation (MOPs) can be used to disrupt the mid palatine suture to make it more pliable to expansion forces.
Micro-osteo perforation (MOPs) along the mid palatal suture which will induce rapid acceleratory phenomenon which would accelerate the bone turnover and reduce the regional bone density leading to transient osteopenia and thus bringing out changes in the transverse dimension.
Cone beam computed tomography (CBCT) allows better imaging at low radiation dosages and presents a clear view of bony structures, tooth position, and type of palatal suture fusion with minimal image distortion. Although hybrid rapid maxillary expansion and minimally
invasive surgical techniques are often used in orthodontic clinical practice, only a few studies have been published in the literature on large groups of patients that present possible complications that may occur after practicing this method of orthodontic treatment.
- Conditions
- Maxillary Anomaly
- Being tested
- hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs)
- Keywords
- maxillary expansion, Micro-osteo perforation, Cross Bite
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs)Procedure or surgery
patients with constricted maxillary will applied for hybrid expansion and group of them will assisted by Micro-osteo perforation (MOPs)
| Study group | Role | What they receive |
|---|---|---|
| intervention group | will receive a hybrid rapid maxillary expander assisted by Micro-osteo perforation (MOPs) in mid palatine suture Receives: Procedure: hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs) | |
| control group | will receive a hybrid rapid maxillary expander without any thing Receives: Procedure: hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBCT measurment
amount of skeletal and dental expansion
Measured: 3 weeks
suture opening
amount of skeletal and dental expansion
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Oct 2024
- Primary completion1 Jun 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maxillary AnomalyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ellamey, Al-Azhar University
- Investigators
- Raafat El ghetany Mohamed, professor, Study director, Al-Azhar UniversityAhmed Akram El-Awady, Lecturer, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467240
- Sponsor's protocol ID
- 984/3700
- Status last verified
- Aug 2025
- First submitted
- 19 May 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baccetti T, Franchi L, Cameron CG, McNamara JA Jr. Treatment timing for rapid maxillary expansion. Angle Orthod. 2001 Oct;71(5):343-50. doi: 10.1043/0003-3219(2001)0712.0.CO;2.
PubMed 11605867McNamara JA. Maxillary transverse deficiency. Am J Orthod Dentofacial Orthop. 2000 May;117(5):567-70. doi: 10.1016/s0889-5406(00)70202-2. No abstract available.
PubMed 10799117
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Hybrid Rapid Maxillary Expander Assisted With Micro-osteo Perforation (MOPs) in Adults: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06467240
- Acronym / sponsor ID
- 984/3700
- Conditions
- Maxillary Anomaly
- Keywords
- maxillary expansion, Micro-osteo perforation, Cross Bite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 20 Jun 2024 (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.
This study will be directed for Evaluation of the hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs) in adults
Detailed description
Transverse maxillary deficiencies are common orthodontic issues observed by professionals. It is estimated that 9.4% of adult orthodontic patients have a transverse maxillary deficiency in combination with a posterior cross bite. A normal transverse skeletal relationship between basal bones is fundamental to achieving a satisfactory and stable occlusion.
Therefore, to correct a maxillary transverse deficiency, palatal expanders are needed. Since Haas popularized this technique in the early 1960s, rapid palatal expanders are the most popular devices of choice, characterized by safety, predictability and efficiency.
The rapid process of activation reduces dental movements (side effects) thus enabling skeletal expansion. Surprisingly, only 30% of the expander opening seems to result in suture opening, whereas one-third reflects alveolar bending and another 30% dental movement.
During activations of traditional tooth-borne rapid palatal expansion devices, heavy transverse forces are generated in a short period of time, causing disruption of the inter sutural tissue thus producing midpalatal suture opening.
On many occasions, these expansion forces in-vivo are in the range of 75-120 N, measured at the level of the hyrax screw of the connecting stainless-steel wire arms at the buccal crowns. In vitro skeletal hybrid expanders, before plastic deformation, demonstrated expansion force values from 67 ± 13 N to 183 ± 48 N when tested on the mini-implant's reinforced bone-anchored wire arms .With these forces, the opening of the palatal suture in adolescents or young adults can be frequently unsuccessful.
Therefore, conventional expanders, under high loads, deform prematurely or create excessive molar tipping or mucosa soreness before
reaching midpalatal suture opening. If these expansion forces are not able to open the suture, surgically assisted rapid palatal expansion (SARPE) is suggested.
In addition, scientific papers do not provide information of the amount of force at the level of the midpalatal suture and the limit of plastic deformation. Solely anchored on orthodontic mini-implants (OMIs) and placed in the anterior-middle palate. These bone anchored expanders seem to improve the aforementioned drawbacks and provide greater expansion forces to facilitate midpalatal suture opening even in adult patients so as to avoid SARPE.
Major areas of resistance to hybrid rapid maxillary expansion are mid palatine suture and the pterygomaxillary articulation. With increasing the age, the interdigitation at sutures increases making the site more rigid. The concept of regional acceleratory phenomenon (RAP) can be used for such clinical challenges by using mild surgical trauma induced by Micro-osteo perforation (MOPs) to produce localized inflammation with the mid palatine suture being the only sight easily accessible for intervention, minimally invasive procedures like Micro-osteo perforation (MOPs) can be used to disrupt the mid palatine suture to make it more pliable to expansion forces.
Micro-osteo perforation (MOPs) along the mid palatal suture which will induce rapid acceleratory phenomenon which would accelerate the bone turnover and reduce the regional bone density leading to transient osteopenia and thus bringing out changes in the transverse dimension.
Cone beam computed tomography (CBCT) allows better imaging at low radiation dosages and presents a clear view of bony structures, tooth position, and type of palatal suture fusion with minimal image distortion. Although hybrid rapid maxillary expansion and minimally
invasive surgical techniques are often used in orthodontic clinical practice, only a few studies have been published in the literature on large groups of patients that present possible complications that may occur after practicing this method of orthodontic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Procedure: hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs)will receive a hybrid rapid maxillary expander assisted by Micro-osteo perforation (MOPs) in mid palatine suture |
| control group | – | Procedure: hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs)will receive a hybrid rapid maxillary expander without any thing |
Who may qualify
- Ages
- 17 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- randamly selected
Key inclusion criteria (6 listed)
- An age range from 17-23 years.
- Transverse maxillary deficiency.
- Maxillary lingual Cross bite (unilateral or bilateral)
- No history of previous orthodontic treatment.
- Good oral and general health.
Key exclusion criteria (5 listed)
- Patient with craniofacial anomalies .
- History of extraction of permanent teeth.
- Previous orthodontic treatment.
- Poor oral hygiene or periodontally compromised patient.
- Previous history of bruxism, trauma or par functions.
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 |
|---|---|---|
| hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs)patients with constricted maxillary will applied for hybrid expansion and group of them will assisted by Micro-osteo perforation (MOPs) | Procedure or surgery | control group, intervention group |
Primary outcome
CBCT measurment
Time frame: 3 weeks
amount of skeletal and dental expansion
suture opening
Time frame: 3 weeks
amount of skeletal and dental expansion
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 8 Sep 2025.
- Background: PubMed 11605867Baccetti T, Franchi L, Cameron CG, McNamara JA Jr. Treatment timing for rapid maxillary expansion. Angle Orthod. 2001 Oct;71(5):343-50. doi: 10.1043/0003-3219(2001)0712.0.CO;2.
- Background: PubMed 10799117McNamara JA. Maxillary transverse deficiency. Am J Orthod Dentofacial Orthop. 2000 May;117(5):567-70. doi: 10.1016/s0889-5406(00)70202-2. No abstract available.
- 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.
Raafat El ghetany Mohamed, professor study director
Al-Azhar University
Ahmed Akram El-Awady, Lecturer study director
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Anomaly, 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 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 8 Sep 2025. 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?
CBCT measurment (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 NCT06467240, which also lists 2 linked publications.
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 8 Sep 2025.