Palatal Expansion TechniqueNCT04225637

Comparison Between Two Rates of Activation of Miniscrew-Supported Upper Jaw Expander in Adolescents

A study testing Miniscrew-Supported Maxillary Expander- Slow activation and Miniscrew-Supported Maxillary Expander- Rapid activation in people with Palatal Expansion Technique and Malocclusion, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 to 16 years
Conditions the study is for: Palatal Expansion Technique, Malocclusion, Posterior Crossbite
What is being tested?: Miniscrew-Supported Maxillary Expander- Slow activation and Miniscrew-Supported Maxillary Expander- Rapid activation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 1 Mar 2019to 1 Jun 2021
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 12 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Permanent dentition.
Participants indicated for skeletal maxillary expansion due to unilateral or bilateral posterior cross bite or maxillary transverse deficiency
Good oral hygiene

Who cannot join

History of previous orthodontic or orthopedic treatment
History of maxillary trauma
Patients with congenital craniofacial malformations
Patients receiving pharmacological agents or having systemic diseases that might affect the bone metabolism or the pain response

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Alexandria University
Alexandria

Other trials in Egypt

About this study

Official title: Comparison Between Two Activation Protocols of Miniscrew-Supported Maxillary Expander in Adolescents: A Randomized Controlled Clinical Trial

Miniscrew-supported maxillary expanders provide advantages over conventional tooth-supported expanders. However, there is no consensus in the literature regarding their activation protocol. The purpose of the clinical trial is to evaluate and compare the effects of slow and rapid activation rates of miniscrew-supported expanders on the skeletal changes, dento-alveolar changes and the pain experience.

Read the detailed description

Transverse maxillary deficiency is one of the problems that are commonly encountered in the orthodontic practice. Miniscrew-supported maxillary expansion represents a promising modality for the treatment of transverse maxillary deficiency. However, controversies still exist regarding the activation protocol. One of these controversies is whether using a slow activation protocol would be more beneficial to the patients compared to a rapid activation protocol. Another question that consequently ensues is whether such activation protocol would result in less pain compared to the rapid activation protocol.

The null hypothesis of the current study is that there is no difference between slow and rapid activation protocols of miniscrew-supported expander.

Conditions: Palatal Expansion Technique, Malocclusion, Posterior Crossbite, Maxillary Hypoplasia
Being tested: Miniscrew-Supported Maxillary Expander- Slow activation, Miniscrew-Supported Maxillary Expander- Rapid activation
Keywords: Rapid Palatal Expansion, Slow Palatal Expansion, Miniscrew, Bone-borne Expander
Medical subject headings: Malocclusion, Retrognathia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Miniscrew-Supported Maxillary Expander- Slow activationDevice
A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated slowly by turning the expansion screw once every other day to correct the transverse maxillary deficiency.
Miniscrew-Supported Maxillary Expander- Rapid activationDevice
A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated rapidly by turning the expansion screw twice per day to correct the transverse maxillary deficiency.

Study groups in NCT04225637
Study group	Role	What they receive
Slow maxillary expansion	Experimental	The miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day. Receives: Device: Miniscrew-Supported Maxillary Expander- Slow activation
Rapid maxillary expansion	Experimental	The miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily. Receives: Device: Miniscrew-Supported Maxillary Expander- Rapid activation

What is being measured

The primary outcome is the main question the study is designed to answer.

Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT)
The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.
Measured: At baseline and an average of 5 months after the initial activation
Dento-alveolar inclination changes from baseline to an average of 5 months after the initial activation, measured using CBCT
The data from CBCT scans at the different time points will be exported in DICOM format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the changes in dento-alveolar inclination from baseline to the end of passive retention of the expansion.
Measured: At baseline and an average of 5 months after the initial activation

Secondary outcomes (4)

Pain score on Numeric Rating Scale (NRS) at baseline
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Measured: Baseline
Pain score on NRS after the first activation of the maxillary expander
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Measured: On day 1 after the first activation of the maxillary expander
Pain score on NRS after 1 week of activation of the maxillary expander
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Measured: After 1 week of activation of the maxillary expander
Pain score on NRS after the last activation of the maxillary expander
Measures pain and how it affects the daily activities on a NRS where each respondent selects a whole number, between 0 and 10, with 0 being the lowest extreme and 10 being the highest extreme.
Measured: At the end of active expansion (an estimated average of 2 to 3 weeks in the rapid expansion group, and 7 to 12 weeks in the slow expansion group)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20191 Jun 2021

First posted13 Jan 2020
Study start1 Mar 2019
Primary completion28 Apr 2021
Study completion1 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Palatal Expansion TechniqueStudies of the same condition, open and under way.
More trials run by Alexandria 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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04225637
Sponsor's protocol ID: 01012019
Status last verified: Jun 2021
First submitted: 5 Jan 2020
Last updated: 21 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.
PubMed 25490552
Yilmaz A, Arman-Ozcirpici A, Erken S, Polat-Ozsoy O. Comparison of short-term effects of mini-implant-supported maxillary expansion appliance with two conventional expansion protocols. Eur J Orthod. 2015 Oct;37(5):556-64. doi: 10.1093/ejo/cju094. Epub 2015 Jan 6.
PubMed 25564504
Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.
PubMed 20197161
Algharbi M, Bazargani F, Dimberg L. Do different maxillary expansion appliances influence the outcomes of the treatment? Eur J Orthod. 2018 Jan 23;40(1):97-106. doi: 10.1093/ejo/cjx035.
PubMed 28486682
Carvalho Trojan L, Andres Gonzalez-Torres L, Claudia Moreira Melo A, Barbosa de Las Casas E. Stresses and Strains Analysis Using Different Palatal Expander Appliances in Upper Jaw and Midpalatal Suture. Artif Organs. 2017 Jun;41(6):E41-E51. doi: 10.1111/aor.12817. Epub 2016 Dec 7.
PubMed 27925236
ElNaghy R, Al-Qawasmi R, Hasanin M. Do patient-reported outcomes of miniscrew-supported maxillary expansion in adolescent patients differ between slow and rapid activation protocol? Evid Based Dent. 2023 Mar;24(1):28-29. doi: 10.1038/s41432-023-00858-8. Epub 2023 Mar 8.
PubMed 36890253

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Teleorthodontics Versus Conventional Follow-up During Early Interceptive Orthodontic Treatment in Children
Teledentistry, Orthodontics, Interceptive
Recruiting
The Effectiveness of Early Intervention to Correct the Position of PDC:s
Ectopic Tooth Eruption, Palatal Expansion Technique
Not yet recruiting
Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea
OSA - Obstructive Sleep Apnea, Palatal Expansion Technique
Recruiting
3D Evaluation of Maxillary Expansion Methods
Maxillary Transverse Deficiency
Recruiting
Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
Palatal Expansion Technique

All Palatal Expansion Technique trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between Two Activation Protocols of Miniscrew-Supported Maxillary Expander in Adolescents: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT04225637
Acronym / sponsor ID: 01012019
Conditions: Palatal Expansion Technique, Malocclusion, Posterior Crossbite, Maxillary Hypoplasia
Keywords: Rapid Palatal Expansion, Slow Palatal Expansion, Miniscrew, Bone-borne Expander
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Alexandria UniversityUniversity, hospital or other
Study start: 1 Mar 2019 (actual)
Primary completion: 28 Apr 2021 (actual)
Study completion: 1 Jun 2021 (actual)
First posted: 13 Jan 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.

Detailed description

The null hypothesis of the current study is that there is no difference between slow and rapid activation protocols of miniscrew-supported expander.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Slow maxillary expansion	Experimental	Device: Miniscrew-Supported Maxillary Expander- Slow activationThe miniscrew-supported maxillary expander is activated by turning the expansion screw once every other day.
Rapid maxillary expansion	Experimental	Device: Miniscrew-Supported Maxillary Expander- Rapid activationThe miniscrew-supported maxillary expander is activated by turning the expansion screw twice daily.

Who may qualify

Ages: 12 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Permanent dentition.
Participants indicated for skeletal maxillary expansion due to unilateral or bilateral posterior cross bite or maxillary transverse deficiency
Good oral hygiene

Key exclusion criteria (4 listed)

History of previous orthodontic or orthopedic treatment
History of maxillary trauma
Patients with congenital craniofacial malformations
Patients receiving pharmacological agents or having systemic diseases that might affect the bone metabolism or the pain response

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
Miniscrew-Supported Maxillary Expander- Slow activationA maxillary expander is supported on 4 palatal miniscrews. The appliance is activated slowly by turning the expansion screw once every other day to correct the transverse maxillary deficiency.	Device	Slow maxillary expansion
Miniscrew-Supported Maxillary Expander- Rapid activationA maxillary expander is supported on 4 palatal miniscrews. The appliance is activated rapidly by turning the expansion screw twice per day to correct the transverse maxillary deficiency.	Device	Rapid maxillary expansion

Primary outcome

Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT)
Time frame: At baseline and an average of 5 months after the initial activation
The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.
Dento-alveolar inclination changes from baseline to an average of 5 months after the initial activation, measured using CBCT
Time frame: At baseline and an average of 5 months after the initial activation
The data from CBCT scans at the different time points will be exported in DICOM format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the changes in dento-alveolar inclination from baseline to the end of passive retention of the expansion.

4 secondary outcomes

Pain score on Numeric Rating Scale (NRS) at baseline
Time frame: Baseline
Pain score on NRS after the first activation of the maxillary expander
Time frame: On day 1 after the first activation of the maxillary expander
Pain score on NRS after 1 week of activation of the maxillary expander
Time frame: After 1 week of activation of the maxillary expander
Pain score on NRS after the last activation of the maxillary expander
Time frame: At the end of active expansion (an estimated average of 2 to 3 weeks in the rapid expansion group, and 7 to 12 weeks in the slow expansion group)

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 Jun 2021.
Background: PubMed 25490552Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.
Background: PubMed 25564504Yilmaz A, Arman-Ozcirpici A, Erken S, Polat-Ozsoy O. Comparison of short-term effects of mini-implant-supported maxillary expansion appliance with two conventional expansion protocols. Eur J Orthod. 2015 Oct;37(5):556-64. doi: 10.1093/ejo/cju094. Epub 2015 Jan 6.
Background: PubMed 20197161Lagravere MO, Carey J, Heo G, Toogood RW, Major PW. Transverse, vertical, and anteroposterior changes from bone-anchored maxillary expansion vs traditional rapid maxillary expansion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2010 Mar;137(3):304.e1-12; discussion 304-5. doi: 10.1016/j.ajodo.2009.09.016.
Background: PubMed 28486682Algharbi M, Bazargani F, Dimberg L. Do different maxillary expansion appliances influence the outcomes of the treatment? Eur J Orthod. 2018 Jan 23;40(1):97-106. doi: 10.1093/ejo/cjx035.
Background: PubMed 27925236Carvalho Trojan L, Andres Gonzalez-Torres L, Claudia Moreira Melo A, Barbosa de Las Casas E. Stresses and Strains Analysis Using Different Palatal Expander Appliances in Upper Jaw and Midpalatal Suture. Artif Organs. 2017 Jun;41(6):E41-E51. doi: 10.1111/aor.12817. Epub 2016 Dec 7.
Derived from this study: PubMed 36890253ElNaghy R, Al-Qawasmi R, Hasanin M. Do patient-reported outcomes of miniscrew-supported maxillary expansion in adolescent patients differ between slow and rapid activation protocol? Evid Based Dent. 2023 Mar;24(1):28-29. doi: 10.1038/s41432-023-00858-8. Epub 2023 Mar 8.
Institutional Review Board (IORG0008839/IRB00010556- Faculty of Dentistry - Alexandria University )Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Palatal Expansion Technique

Active, not recruiting
Teleorthodontics Versus Conventional Follow-up During Early Interceptive Orthodontic Treatment in Children
Teledentistry, Orthodontics, Interceptive
Recruiting
The Effectiveness of Early Intervention to Correct the Position of PDC:s
Ectopic Tooth Eruption, Palatal Expansion Technique
Not yet recruiting
Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea
OSA - Obstructive Sleep Apnea, Palatal Expansion Technique
Recruiting
3D Evaluation of Maxillary Expansion Methods
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Recruiting
Evaluation of Hard and Soft Tissue Change During Maxillary Expansion Using a Computer-aided Design / Computer-aided Manufacturing Appliance.
Palatal Expansion Technique

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.

Yomna M Yacout, BDS, MSc principal investigator

Alexandria University

Nadia M El Harouni, BDS,MSc,PhD study chair

Alexandria University

Essam M Abdallah, BDS,MSc,PhD study chair

Alexandria University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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 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 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?

Transverse skeletal changes from baseline to an average of 5 months after the initial activation, measured using cone beam computed tomography (CBCT) (time frame: At baseline and an average of 5 months after the initial activation). 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 NCT04225637, which also lists 6 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 21 Jun 2021.