ConstrictionNCT05248087

Pain, Discomfort, and Functional Impairments During Maxillary Expansion

A study testing The bonded McNamara-type appliance and The removable palatal expansion appliance in people with Constriction, run by Damascus University at 1 site in Syria.

Completed

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

Official record

Search all trials

Trial summary

Maxillary expansion is associated with varying degrees of pain and functional impairments. The current study aims to compare rapid maxillary expansion using a McNamara-type (bonded) appliance and slow maxillary expansion using a removable palatal expansion appliance concerning patient-centered outcomes. Read more about this study

Who is it for?: Ages 12 to 16 years
Conditions the study is for: Constriction
What is being tested?: The bonded McNamara-type appliance and The removable palatal expansion appliance
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteSyria
Study dates: 20 Feb 2020to 25 Jul 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

Adolescents between 12 and 16 years.
Early permanent dentition.
Skeletal bilateral maxillary constriction.
There is no loss or absence of any permanent teeth except for the third molar.
Dental and skeletal class I/II malocclusion.
Normal/mild vertical growth pattern.

Who cannot join

Previous orthodontic treatment.
A severe horizontal growth pattern.
Any periodontal diseases.
Any general diseases or syndromes.

Trial locations and contacts

1 site in 1 country.

Syria1 site

University of Damascus
Damascus

Other trials in Syria

About this study

Official title: Assessment of Patient-centered Outcomes Associated With the Expansion of Skeletally Constricted Upper Jaw in the Adolescents Using Two Types of Expanders: A Randomized Controlled Trial

Read the detailed description

Skeletal maxillary constriction is one of the common orthodontic problems of all ages, which could be unilateral or bilateral. If it is neglected and not treated, it may result in later orthodontic problems such as skeletal deviation of the lower jaw. The current study aims to use two types of expanders to treat skeletal maxillary constriction in adolescents aged between 12 and 16 years. The study sample will include 52 patients who will be equally divided into two groups: the slow and the rapid maxillary expansion groups. Patients will be asked to answer a questionnaire within five assessment times during the expansion procedure. The questionnaire will contain four questions: 1) What is the degree of discomfort/pain? 2) What is the degree of mastication difficulties? 3) What is the degree of swallowing difficulties? 4) What is the degree of any sense of pressure in soft tissue?

Conditions: Constriction
Being tested: The bonded McNamara-type appliance, The removable palatal expansion appliance
Keywords: Pain, Discomfort, Crossbite, Maxillary expansion
Medical subject headings: Constriction, Pathologic, Pain, Malocclusion

What participants receive

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

The bonded McNamara-type applianceDevice
The patient will be asked to expand twice a day until obtaining an overcorrection of 2-3 mm. Then the expander will be kept in place for three months as a retention period.
The removable palatal expansion applianceDevice
The slow maxillary expansion will be applied using a removable palatal expansion appliance with a midline screw. The patient will be asked to expand twice a week until obtaining an overcorrection of 2-3 mm.

Study groups in NCT05248087
Study group	Role	What they receive
The rapid maxillary expansion	Experimental	The rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance. Receives: Device: The bonded McNamara-type appliance
The slow maxillary expansion	Active comparator	The slow maxillary expansion will be applied using a removable palatal expansion appliance. Receives: Device: The removable palatal expansion appliance

What is being measured

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

Change in the levels of discomfort or pain
The degree of pain and discomfort that patients feel will be determined using their answers to the following question (question 01):
'What is the degree of discomfort/pain?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of discomfort/pain.
Measured: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Change in the levels of mastication difficulties
The degree of mastication difficulties that patients feel will be determined using their answers to the following question (question 02):
'What is the degree of mastication difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of mastication difficulties.
Measured: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Change in the levels of swallowing difficulties
The degree of swallowing difficulties that patients feel will be determined using their answers to the following question (question 03):
' What is the degree of swallowing difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of swallowing difficulties.
Measured: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
Change in the levels of sensation of pressure on soft tissue
The degree of any sense of pressure in soft tissue that patients feel will be determined using their answers to the following question (question 04):
' What is the degree of any sense of pressure in soft tissue? ' The Visual Analogue Scale (VAS) will be adopted to measure the degree of any sense of pressure in soft tissue.
Measured: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months

Timeline

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

20 Feb 202025 Jul 2021

First posted21 Feb 2022
Study start20 Feb 2020
Primary completion20 Mar 2021
Study completion25 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for ConstrictionStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05248087
Sponsor's protocol ID: UDDS-Ortho-02-2022
Status last verified: Feb 2022
First submitted: 10 Feb 2022
Last updated: 21 Feb 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.
PubMed 23758461
Halicioglu K, Kiki A, Yavuz I. Subjective symptoms of RME patients treated with three different screw activation protocols: a randomised clinical trial. Aust Orthod J. 2012 Nov;28(2):225-31.
PubMed 23304972
Feldmann I, Bazargani F. Pain and discomfort during the first week of rapid maxillary expansion (RME) using two different RME appliances: A randomized controlled trial. Angle Orthod. 2017 May;87(3):391-396. doi: 10.2319/091216-686.1. Epub 2016 Dec 28.
PubMed 28029266
Ugolini A, Cossellu G, Farronato M, Silvestrini-Biavati A, Lanteri V. A multicenter, prospective, randomized trial of pain and discomfort during maxillary expansion: Leaf expander versus hyrax expander. Int J Paediatr Dent. 2020 Jul;30(4):421-428. doi: 10.1111/ipd.12612. Epub 2020 Jan 20.
PubMed 31894603
De Felippe NL, Da Silveira AC, Viana G, Smith B. Influence of palatal expanders on oral comfort, speech, and mastication. Am J Orthod Dentofacial Orthop. 2010 Jan;137(1):48-53. doi: 10.1016/j.ajodo.2008.01.023.
PubMed 20122430

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?

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All Constriction trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Patient-centered Outcomes Associated With the Expansion of Skeletally Constricted Upper Jaw in the Adolescents Using Two Types of Expanders: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05248087
Acronym / sponsor ID: UDDS-Ortho-02-2022
Conditions: Constriction
Keywords: Pain, Discomfort, Crossbite, Maxillary expansion
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 20 Feb 2020 (actual)
Primary completion: 20 Mar 2021 (actual)
Study completion: 25 Jul 2021 (actual)
First posted: 21 Feb 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.

Detailed description

Study design

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

Arm	Type	Receives
The rapid maxillary expansion	Experimental	Device: The bonded McNamara-type applianceThe rapid maxillary expansion will be applied using a McNamara-type (bonded) appliance.
The slow maxillary expansion	Active comparator	Device: The removable palatal expansion applianceThe slow maxillary expansion will be applied using a removable palatal expansion appliance.

Who may qualify

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

Key inclusion criteria (6 listed)

Adolescents between 12 and 16 years.
Early permanent dentition.
Skeletal bilateral maxillary constriction.
There is no loss or absence of any permanent teeth except for the third molar.
Dental and skeletal class I/II malocclusion.

Key exclusion criteria (4 listed)

Previous orthodontic treatment.
A severe horizontal growth pattern.
Any periodontal diseases.
Any general diseases or syndromes.

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
The bonded McNamara-type applianceThe patient will be asked to expand twice a day until obtaining an overcorrection of 2-3 mm. Then the expander will be kept in place for three months as a retention period.	Device	The rapid maxillary expansion
The removable palatal expansion applianceThe slow maxillary expansion will be applied using a removable palatal expansion appliance with a midline screw. The patient will be asked to expand twice a week until obtaining an overcorrection of 2-3 mm.	Device	The slow maxillary expansion

Primary outcome

Change in the levels of discomfort or pain
Time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
The degree of pain and discomfort that patients feel will be determined using their answers to the following question (question 01): 'What is the degree of discomfort/pain?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of discomfort/pain.
Change in the levels of mastication difficulties
Time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
The degree of mastication difficulties that patients feel will be determined using their answers to the following question (question 02): 'What is the degree of mastication difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of mastication difficulties.
Change in the levels of swallowing difficulties
Time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
The degree of swallowing difficulties that patients feel will be determined using their answers to the following question (question 03): ' What is the degree of swallowing difficulties?' The Visual Analogue Scale (VAS) will be adopted to measure the degree of swallowing difficulties.
Change in the levels of sensation of pressure on soft tissue
Time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months
The degree of any sense of pressure in soft tissue that patients feel will be determined using their answers to the following question (question 04): ' What is the degree of any sense of pressure in soft tissue? ' The Visual Analogue Scale (VAS) will be adopted to measure the degree of any sense of pressure in soft tissue.

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 Feb 2022.
Background: PubMed 23758461Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.
Background: PubMed 23304972Halicioglu K, Kiki A, Yavuz I. Subjective symptoms of RME patients treated with three different screw activation protocols: a randomised clinical trial. Aust Orthod J. 2012 Nov;28(2):225-31.
Background: PubMed 28029266Feldmann I, Bazargani F. Pain and discomfort during the first week of rapid maxillary expansion (RME) using two different RME appliances: A randomized controlled trial. Angle Orthod. 2017 May;87(3):391-396. doi: 10.2319/091216-686.1. Epub 2016 Dec 28.
Background: PubMed 31894603Ugolini A, Cossellu G, Farronato M, Silvestrini-Biavati A, Lanteri V. A multicenter, prospective, randomized trial of pain and discomfort during maxillary expansion: Leaf expander versus hyrax expander. Int J Paediatr Dent. 2020 Jul;30(4):421-428. doi: 10.1111/ipd.12612. Epub 2020 Jan 20.
Background: PubMed 20122430De Felippe NL, Da Silveira AC, Viana G, Smith B. Influence of palatal expanders on oral comfort, speech, and mastication. Am J Orthod Dentofacial Orthop. 2010 Jan;137(1):48-53. doi: 10.1016/j.ajodo.2008.01.023.
Individual participant dataSharing planned: No

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Aortic Stenosis Treated With TAVI, Aortic Diseases
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Active, not recruitingObservational study
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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.

Nancy Rabah, DDS,MSc principal investigator

Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus

Heba M Al-Ibrahim, DDS,MSc principal investigator

Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus

Mohammad Y Hajeer, DDS,MSc,PhD study chair

Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

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

Questions about this trial

What is this clinical trial studying?

A study testing The bonded McNamara-type appliance and The removable palatal expansion appliance in people with Constriction, run by Damascus University at 1 site in Syria.

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 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 Feb 2022. 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 Syria. 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?

Change in the levels of discomfort or pain (time frame: T1: after 24 hours; T2: on the 7th day; T3: on the 15th day; T4: after 1 month; T5: after 4 months). The study lists 4 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 NCT05248087, which also lists 5 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 Feb 2022.