Maxillary Dysostosis (Disorder)ALT/MARPENCT04908540
New Maxillary Expansion Technique in Adults
A study testing Mini-screw Assissted Rapid Palatal Expansion in people with Maxillary Dysostosis (Disorder), run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
Previous studies confirmed that MARPE (Mini-screw Assisted Rapid Palatal Expansion) technique resulted in transverse skeletal expansion without the undesired dentoalveolar compensations or drawbacks. It also resulted in widening of the nasal cavity and zygomatic bone. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Dysostosis (Disorder)
- What is being tested?
- Mini-screw Assissted Rapid Palatal Expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Apr 2021to Sep 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All cases showed maxillary skeletal deficiency. (Antero-posterior, or Transverse unilateral/ bilateral posterior cross bite).
- No history of facial orthopedic or orthognathic treatment before.
- No craniofacial anomaly or had history of serious craniofacial injuries.
- No history of serious medical illness such as (heart conditions, organ transplants, immune-compromised health issues, or cancer in patients undergoing chemotherapy or radiation treatments) or chronic diseases such as (Diabetes mellitus). As they are patients highly susceptible to infection which may result in worsening their medical status or even in a fatality in case of absence or inadequacy of precautions and proper pre/post medication coverage.
- Good oral hygiene and non-smoking habit.
Who cannot join
- Patient with missing or impacted 1st molars
- Patients with chronic gingival inflammation, gingival recession, or bone resorption.
- High gag reflex patients
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
Norma Ab Rahman, 0060199818248, drnorma@usm.my
About this study
Official title: Evaluatin of Maxillery Skeletal Expansion in Young Adults, With Two Different Activation Protocols. A Randomized Clinical Trial
Previous studies confirmed that MARPE (Mini-screw Assisted Rapid Palatal Expansion) technique resulted in transverse skeletal expansion without the undesired dentoalveolar compensations or drawbacks. It also resulted in widening of the nasal cavity and zygomatic bone. ALT-RAMEC (Alternate Rapid Maxillary Expansion and Constriction) in literature proved to be advantageous over conventional RME in producing subluxation and sutural displacement to facilitate maxillary protraction in skeletal class III growing patients.The current study investigates the efficacy of a combination of MARPE/ ALT-RAMEC techniques to expand the maxilla in adult cases of transverse maxillary deficiency. It compares the proportion of success cases in patients who are treated with MARPE/ ALT-RAMEC to those treated using MARPE (conventional). It also describes the circum-maxillary sutural displacement in patients treated with both techniques, it hypothesizes that it will result in transverse skeletal expansion as well as sutural subluxation and displacement in young adult ages, which may be a sign of hope in the treatment of antero-posterior deficiency in adults without resorting to surgery. It also will describe the dento-skeletal changes (the amount of dental tipping) and the respiratory changes that occurred after applying the two different expansion techniques. It will also compare clinically, the changes occur gingivally (Gingival recession and Pocket depths) between pre-treatment and post-expansion periods.
Read the detailed description
Patient with functional or esthetic complain (malocclusion) attending Dental Clinics in Al-Azhar University seeking orthodontic treatment, will be screened. Orthodontic young adult patients with transverse maxillary deficiency (as a primary diagnosis) will be selected from the list (by the study operator), based on inclusion and exclusion criteria. For this research purpose all subjects, whatever their number, who met the inclusion criteria, will be informed details of the expansion procedure, and about the whole study purposes, risks and benefits. Patient who agree to be a part of this research work, informed written consent will be taken from them. The patient will be divided randomly into two studying group, with a control group, Group A: (MARPE/ Conven), who will receive MARPE with its conventional expansion, and interventional group, Group B: who will receive a combination of MARPE/ALT-RAMEC technique. This randomization process will be carried out by the study operator using 30 sealed and shuffled envelopes, to blind both the operator and the participants during assignment to the groups. When a patient selects a group name, the operator will enroll him/her in the specific group list with allocation ratio 1:1 (15 patients in each group). Patient first visit (after assignment in the study) will take about 1 hour for preliminary evaluation, and T1 CBCT imaging. extra and intra oral assessment will be carried out to assess the dentition, occlusion type, periodontal status, and oral hygiene. Pretreatment CBCT imaging, gingival recession depths, and sulcus depths, will be taken as T1 records and interdental separating elastics will be used mesial and distal to 1st molars to provide adequate space for 1st molar banding.
Then a second visit will be required for impression taking, where orthodontic 1st molar bands will be selected and fitted properly in position for conventional alginate transfere impression to be taken for appliance laboratory construction. After that, dental separators will be reinserted again in their position. After which, and during the third visit (which might be the longest, 2 hours visit) the appliance will be loaded intraorally after local anesthesia infiltration using 4 mini-screws with previously planned length according to each patient palatal bone and soft tissue height. Then immediate activations (2-3 initial quarter turns), written hygiene, and activation instructions will be given to the patients in each group. In Group A (MARPE/conven) (Control), patients will open 2 quarter turn (0.2 mm) in the morning, and 2 quarter turn in the evening until overcorrection achieved. While in Group B (MARPE/ALT-RAMEC) (Interventional), patients will open 2 quarter turn (0.2mm) in the morning, and 2 in the evening in the first week, then alternate with closing 2 quarter turn in the morning and 2 in the evening in the second week. And then continuing opening and closing till end with opening in the 7th week and continue opening until overcorrection achieved. Patients will be followed up every week (1/2 an hour visit) for assessment of oral hygiene and interdental diastema appearance. In control group, if patients showed central diastema before 2-3 week , they will continue expansion till achieving overcorrection. But if they didn't show diastema after the 2-3 weeks, they will be terminated from the study and referred to maxillofacial surgery department for surgically assisted rapid palatal expansion (SARPE). In MARPE/ALT-RAMEC group, if patients showed diastema before 7-8 weeks of alternating expansion and constriction, they will continue only expansion till achieving overcorrection. But if they didn't; they will be terminated from the study and referred to maxillofacial surgery department for SARPE. All patients at the end of their expansion protocol, will get their T2 CBCT imaging and intra- oral measurements. Data collection from T1 and T2 CBCT records will be done by the study operator and then will be repeated again after 2 weeks of complete data collection by the same operator for data reliability. The patients who continue the expansion will be followed up until overcorrection is achieved which would take about 1-2 weeks after confirmation of median diastema event. The overall duration of participant involvement in group A (Control) is about 3-4 weeks, while in group B (Interventional) it will range from 8- 9 weeks.
- Conditions
- Maxillary Dysostosis (Disorder)
- Being tested
- Mini-screw Assissted Rapid Palatal Expansion
- Keywords
- Adult Maxillary Expansion, Activation Protocols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-screw Assissted Rapid Palatal ExpansionProcedure or surgery
Also called Maxillary Skeletal Expansion
Mini-screw assissted RPE will be the main intervention in the two comparative groups. In the control (group A) will be used with its conventional activation protocol. While in experimental (group B) will be used with ALT-RAMEC protocol.
| Study group | Role | What they receive |
|---|---|---|
| MARPE/ Conventional (Control) (Group A) | Active comparator | patients will open the appliance in its conventional way; 2 quarter turn (0.2 mm) in the morning, and 2 quarter turn in the evening until overcorrection achieved. Receives: Procedure: Mini-screw Assissted Rapid Palatal Expansion |
| MARPE/ ALT-RAMEC (Group B) | Experimental | Patients will open 2 quarter turn (0.2mm) in the morning, and 2 in the evening in the first week, then alternate with closing 2 quarter turn in the morning and 2 in the evening in the second week. And then continuing opening and closing till end with opening in the 7th week and continue opening until overcorrection achieved. Receives: Procedure: Mini-screw Assissted Rapid Palatal Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transverse palatal Expansion
Achieving skeletal expansion in the posterior cross bite, which will be observed clinically by mid-palatal suture splitting (central diastema) then molar overcorrection, when the palatal cusp of either maxillary first molar came in contact with the corresponding buccal cusp tips of the mandibular first molar.
Measured: 2-9 weeks
Sutural Displacement
Producing increased circum-maxillary sutural displacement measured from CBCT images, when comparing MARPE with ALT-RAMEC than MARPE with its conventional use.
Measured: 2-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Apr 2021
- Primary completionMar 2022 (estimated)
- Study completionSep 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 Dysostosis (Disorder)Studies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Azhar University
- Responsible party
- Principal investigator, Amira Hussein Ahmed Mohamed Allam, Universiti Sains Malaysia
- Investigators
- Norma Ab Rahman, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908540
- Sponsor's protocol ID
- PhD Amira USM
- Acronym
- ALT/MARPE
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Allam A, Mostafa M, Ahmad B, Salama A, Rahman NA. The sutural and dentoskeletal effects of alternate expansion and constriction of deficient maxilla in young adults: a randomized controlled clinical trial. BMC Oral Health. 2025 Jul 13;25(1):1156. doi: 10.1186/s12903-025-06489-y.
PubMed 40653475
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatin of Maxillery Skeletal Expansion in Young Adults, With Two Different Activation Protocols. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04908540
- Acronym / sponsor ID
- ALT/MARPE / PhD Amira USM
- Conditions
- Maxillary Dysostosis (Disorder)
- Keywords
- Adult Maxillary Expansion, Activation Protocols
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Al-Azhar University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 1 Jun 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.
Previous studies confirmed that MARPE (Mini-screw Assisted Rapid Palatal Expansion) technique resulted in transverse skeletal expansion without the undesired dentoalveolar compensations or drawbacks. It also resulted in widening of the nasal cavity and zygomatic bone. ALT-RAMEC (Alternate Rapid Maxillary Expansion and Constriction) in literature proved to be advantageous over conventional RME in producing subluxation and sutural displacement to facilitate maxillary protraction in skeletal class III growing patients.The current study investigates the efficacy of a combination of MARPE/ ALT-RAMEC techniques to expand the maxilla in adult cases of transverse maxillary deficiency. It compares the proportion of success cases in patients who are treated with MARPE/ ALT-RAMEC to those treated using MARPE (conventional). It also describes the circum-maxillary sutural displacement in patients treated with both techniques, it hypothesizes that it will result in transverse skeletal expansion as well as sutural subluxation and displacement in young adult ages, which may be a sign of hope in the treatment of antero-posterior deficiency in adults without resorting to surgery. It also will describe the dento-skeletal changes (the amount of dental tipping) and the respiratory changes that occurred after applying the two different expansion techniques. It will also compare clinically, the changes occur gingivally (Gingival recession and Pocket depths) between pre-treatment and post-expansion periods.
Detailed description
Patient with functional or esthetic complain (malocclusion) attending Dental Clinics in Al-Azhar University seeking orthodontic treatment, will be screened. Orthodontic young adult patients with transverse maxillary deficiency (as a primary diagnosis) will be selected from the list (by the study operator), based on inclusion and exclusion criteria. For this research purpose all subjects, whatever their number, who met the inclusion criteria, will be informed details of the expansion procedure, and about the whole study purposes, risks and benefits. Patient who agree to be a part of this research work, informed written consent will be taken from them. The patient will be divided randomly into two studying group, with a control group, Group A: (MARPE/ Conven), who will receive MARPE with its conventional expansion, and interventional group, Group B: who will receive a combination of MARPE/ALT-RAMEC technique. This randomization process will be carried out by the study operator using 30 sealed and shuffled envelopes, to blind both the operator and the participants during assignment to the groups. When a patient selects a group name, the operator will enroll him/her in the specific group list with allocation ratio 1:1 (15 patients in each group). Patient first visit (after assignment in the study) will take about 1 hour for preliminary evaluation, and T1 CBCT imaging. extra and intra oral assessment will be carried out to assess the dentition, occlusion type, periodontal status, and oral hygiene. Pretreatment CBCT imaging, gingival recession depths, and sulcus depths, will be taken as T1 records and interdental separating elastics will be used mesial and distal to 1st molars to provide adequate space for 1st molar banding.
Then a second visit will be required for impression taking, where orthodontic 1st molar bands will be selected and fitted properly in position for conventional alginate transfere impression to be taken for appliance laboratory construction. After that, dental separators will be reinserted again in their position. After which, and during the third visit (which might be the longest, 2 hours visit) the appliance will be loaded intraorally after local anesthesia infiltration using 4 mini-screws with previously planned length according to each patient palatal bone and soft tissue height. Then immediate activations (2-3 initial quarter turns), written hygiene, and activation instructions will be given to the patients in each group. In Group A (MARPE/conven) (Control), patients will open 2 quarter turn (0.2 mm) in the morning, and 2 quarter turn in the evening until overcorrection achieved. While in Group B (MARPE/ALT-RAMEC) (Interventional), patients will open 2 quarter turn (0.2mm) in the morning, and 2 in the evening in the first week, then alternate with closing 2 quarter turn in the morning and 2 in the evening in the second week. And then continuing opening and closing till end with opening in the 7th week and continue opening until overcorrection achieved. Patients will be followed up every week (1/2 an hour visit) for assessment of oral hygiene and interdental diastema appearance. In control group, if patients showed central diastema before 2-3 week , they will continue expansion till achieving overcorrection. But if they didn't show diastema after the 2-3 weeks, they will be terminated from the study and referred to maxillofacial surgery department for surgically assisted rapid palatal expansion (SARPE). In MARPE/ALT-RAMEC group, if patients showed diastema before 7-8 weeks of alternating expansion and constriction, they will continue only expansion till achieving overcorrection. But if they didn't; they will be terminated from the study and referred to maxillofacial surgery department for SARPE. All patients at the end of their expansion protocol, will get their T2 CBCT imaging and intra- oral measurements. Data collection from T1 and T2 CBCT records will be done by the study operator and then will be repeated again after 2 weeks of complete data collection by the same operator for data reliability. The patients who continue the expansion will be followed up until overcorrection is achieved which would take about 1-2 weeks after confirmation of median diastema event. The overall duration of participant involvement in group A (Control) is about 3-4 weeks, while in group B (Interventional) it will range from 8- 9 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MARPE/ Conventional (Control) (Group A) | Active comparator | Procedure: Mini-screw Assissted Rapid Palatal Expansionpatients will open the appliance in its conventional way; 2 quarter turn (0.2 mm) in the morning, and 2 quarter turn in the evening until overcorrection achieved. |
| MARPE/ ALT-RAMEC (Group B) | Experimental | Procedure: Mini-screw Assissted Rapid Palatal ExpansionPatients will open 2 quarter turn (0.2mm) in the morning, and 2 in the evening in the first week, then alternate with closing 2 quarter turn in the morning and 2 in the evening in the second week. And then continuing opening and closing till end with opening in the 7th week and continue opening until overcorrection achieved. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All cases showed maxillary skeletal deficiency. (Antero-posterior, or Transverse unilateral/ bilateral posterior cross bite).
- No history of facial orthopedic or orthognathic treatment before.
- No craniofacial anomaly or had history of serious craniofacial injuries.
- No history of serious medical illness such as (heart conditions, organ transplants, immune-compromised health issues, or cancer in patients undergoing chemotherapy or radiation treatments) or chronic diseases such as (Diabetes mellitus). As they are patients highly susceptible to infection which may result in worsening their medical status or even in a fatality in case of absence or inadequacy of precautions and proper pre/post medication coverage.
- Good oral hygiene and non-smoking habit.
Key exclusion criteria (3 listed)
- Patient with missing or impacted 1st molars
- Patients with chronic gingival inflammation, gingival recession, or bone resorption.
- High gag reflex patients
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 |
|---|---|---|
| Mini-screw Assissted Rapid Palatal ExpansionAlso: Maxillary Skeletal ExpansionMini-screw assissted RPE will be the main intervention in the two comparative groups. In the control (group A) will be used with its conventional activation protocol. While in experimental (group B) will be used with ALT-RAMEC protocol. | Procedure or surgery | MARPE/ ALT-RAMEC (Group B), MARPE/ Conventional (Control) (Group A) |
Primary outcome
Transverse palatal Expansion
Time frame: 2-9 weeks
Achieving skeletal expansion in the posterior cross bite, which will be observed clinically by mid-palatal suture splitting (central diastema) then molar overcorrection, when the palatal cusp of either maxillary first molar came in contact with the corresponding buccal cusp tips of the mandibular first molar.
Sutural Displacement
Time frame: 2-9 weeks
Producing increased circum-maxillary sutural displacement measured from CBCT images, when comparing MARPE with ALT-RAMEC than MARPE with its conventional use.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 40653475Allam A, Mostafa M, Ahmad B, Salama A, Rahman NA. The sutural and dentoskeletal effects of alternate expansion and constriction of deficient maxilla in young adults: a randomized controlled clinical trial. BMC Oral Health. 2025 Jul 13;25(1):1156. doi: 10.1186/s12903-025-06489-y.
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.
Norma Ab Rahman study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-screw Assissted Rapid Palatal Expansion in people with Maxillary Dysostosis (Disorder), run by Universiti Sains Malaysia at 1 site in Malaysia.
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 5 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 1 Jun 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 Malaysia. 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 Amira Allam (00201007041009, amira.allam_dent@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transverse palatal Expansion (time frame: 2-9 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 NCT04908540, 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 1 Jun 2021.