Transverse Maxillary DeficiencyNCT06009796

The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance

A study testing Tooth Tissue Borne Rapid Palatal Expansion and Tooth Bone Borne Rapid Palatal Expansion in people with Transverse Maxillary Deficiency, run by TC Erciyes University at 1 site in Turkey (Türkiye).

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

This study aims to evaluate the effects of dentoalveolar, dentoskeletal, nasal resistance, and airway changes by applying rapid palatal expansion appliances in patients with maxillary constriction and the post-pubertal growth spurt stage. Read more about this study

Who is it for?: Ages 14 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Transverse Maxillary Deficiency
What is being tested?: Tooth Tissue Borne Rapid Palatal Expansion and Tooth Bone Borne Rapid Palatal Expansion
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 11 Nov 2022to 12 Jul 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 14 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

With a unilateral or bilateral morphological lateral crossbite
Whose first molars and premolars had completely erupted at pretreatment
With maxillary constriction of more than 4 mm and less than 10 mm
Who were going through the post-pubertal growth spurt stage based on hand-wrist radiographs
Individuals with a body mass index of 18-24
Individuals with an ANB angle between 0º and 4º

Who cannot join

craniofacial anomalies
compliance problems
systemic or genetic disease
previous orthodontic treatment history

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Erciyes University Faculty of Dentistry ,Department of Orthodontics
Kayseri, 38000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance: A Prospective, Randomized Controlled Trial

Read the detailed description

Fifty eight patients were divided into 4 groups. The first group (n: 15, 15.6 ± 1,1 years of age) was Full Coverage Rapid Palatal Expansion (FCRPE). The second group ( n:14, 15.3 ± 0,9 years of age) was Modified McNamara Rapid Palatal Expansion (MMRPE). The third group (n:14, 15.7 ± 1,1 years of age) was Miniimplant Assisted Rapid Palatal Expansion (MARPE). The fourth group (n:15, 15.4 ± 1,0 years of age) was control group. Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model, and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.

Conditions: Transverse Maxillary Deficiency
Being tested: Tooth Tissue Borne Rapid Palatal Expansion, Tooth Bone Borne Rapid Palatal Expansion
Keywords: Maxillary expansion, Respiratory polygraphy, Rhinomanometry, MARPE

What participants receive

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

Tooth Tissue Borne Rapid Palatal ExpansionDevice
In all rapid palatal expansion groups, the appliances were cis bonded after being made by the same technician. The expansion screw was turned twice a day until the desired width was achieved.
Tooth Bone Borne Rapid Palatal ExpansionDevice
After the Marpe appliance was attached, 4 miniscrews were applied to the midline of the palate with a miniscrew driver. The expansion screw was turned twice a day until the desired width was achieved.

Study groups in NCT06009796
Study group	Role	What they receive
Full Coverage Rapid Palatal Expansion (FCRPE) group:	Active comparator	Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of all maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized. Receives: Device: Tooth Tissue Borne Rapid Palatal Expansion
Modified McNamara Rapid Palatal Expansion (MMRPE) Group:	Active comparator	Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of the posterior maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized. Receives: Device: Tooth Tissue Borne Rapid Palatal Expansion
Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group	Active comparator	The MARPE appliance was composed of a central expansion jackscrew (Dentarum), 4 tubes, 2 bands on the upper first molars to facilitate placement of the appliance, and 1.5-mm diameter stainless steel arms extending to the premolar teeth. Soldered stainless steel tubes (internal diameter: 2.0 mm; external diameter: 3.0 mm; length: 2.0 mm) served as guides for miniscrew placement. The size of the screws (PSM) was chosen as 1.8 mm in diameter and 11 mm in length, considering the 2 mm height of the tubes, 1 to 2 mm gap between the appliance and the palate surface, 1 to 2 mm gingiva thickness, and 5 to 6 mm length required for the bicortical placement of the screw in the bone. Receives: Device: Tooth Bone Borne Rapid Palatal Expansion
Control Group	No intervention	A control group in the same age, without maxillary constriction was also added to our study.Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance were used. Polygraphy and rhinomanometry measurements were obtained at the beginning of the follow-up and at the end of the 4-month follow-up period.

What is being measured

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

Rhinomanometry Measurement Parameters (Pa/cm3/sn )
-Total Nasal Resistance(Pa/cm3/sn ): In our study, total nasal resistance was measured with a rhinomanometry device.
Measured: up to 1 year
Polygraphy Measurement Parameters (event/hour)
- Apnea-Hypopnea Index (event/hour) : In our study, Apnea-Hypopnea Index(AHI) was measured with a polygraphy device. - Oxygen Desaturation index (De SPO2) : In our study, De SPO2 was measured with a polygraphy device.
Measured: up to 1 year

Secondary outcomes (2)

Postero-anterior Measurement Parameters(mm)
- NCB-NCB': Distance between right and left nasal cavity borders(mm)
- JP-JP' : Distance between right and left jugal processes(mm)
- AGP-AGP' : Distance between right and left antagonial points(mm)
Measured: up to 1 year
Model Measurement Parameters(mm)
- C-C : Distance between cusp crests of canines(mm)
- C'-C' : Distance between cingulum of canines(mm)
- M1-M1 : The distance between buccal tubercles of first molar(mm)
- M1'-M1' : The distance between the lingual tubercles of first molar(mm)
Measured: up to 1 year

Timeline

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

11 Nov 202212 Jul 2023

First posted24 Aug 2023
Study start11 Nov 2022
Primary completion14 Mar 2023
Study completion12 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Transverse Maxillary DeficiencyStudies of the same condition, open and under way.
More trials run by TC Erciyes 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
Model description: Fifty eight patients were divided into 4 groups: FCRPE group (n: 15, 15.6 ± 1,1 years of age), MMRPE group (n:14, 15.3 ± 0,9 years of age), MARPE group (n:14, 15.7 ± 1,1 years of age), Control group (n:15, 15.4 ± 1,0 years of age). Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06009796
Sponsor's protocol ID: TDH-2022-12101
Status last verified: Aug 2023
First submitted: 16 Aug 2023
Last updated: 24 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lagravere MO, Major PW, Flores-Mir C. Skeletal and dental changes with fixed slow maxillary expansion treatment: a systematic review. J Am Dent Assoc. 2005 Feb;136(2):194-9. doi: 10.14219/jada.archive.2005.0141.
PubMed 15782523
Lee KJ, Park YC, Park JY, Hwang WS. Miniscrew-assisted nonsurgical palatal expansion before orthognathic surgery for a patient with severe mandibular prognathism. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):830-9. doi: 10.1016/j.ajodo.2007.10.065.
PubMed 20685540
Seeberger R, Kater W, Schulte-Geers M, Davids R, Freier K, Thiele O. Changes after surgically-assisted maxillary expansion (SARME) to the dentoalveolar, palatal and nasal structures by using tooth-borne distraction devices. Br J Oral Maxillofac Surg. 2011 Jul;49(5):381-5. doi: 10.1016/j.bjoms.2010.05.015. Epub 2010 Jun 17.
PubMed 21683264

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

Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
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Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
Maxillary Transverse Deficiency
Not yet recruiting
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Maxillary Transverse Deficiency, Rapid Maxillary Expansion
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
Recruiting
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients

All Transverse Maxillary Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance: A Prospective, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06009796
Acronym / sponsor ID: TDH-2022-12101
Conditions: Transverse Maxillary Deficiency
Keywords: Maxillary expansion, Respiratory polygraphy, Rhinomanometry, MARPE
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: TC Erciyes UniversityUniversity, hospital or other
Study start: 11 Nov 2022 (actual)
Primary completion: 14 Mar 2023 (actual)
Study completion: 12 Jul 2023 (actual)
First posted: 24 Aug 2023 (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: None (open label)
Number of arms: 4
Model description: Fifty eight patients were divided into 4 groups: FCRPE group (n: 15, 15.6 ± 1,1 years of age), MMRPE group (n:14, 15.3 ± 0,9 years of age), MARPE group (n:14, 15.7 ± 1,1 years of age), Control group (n:15, 15.4 ± 1,0 years of age). Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.

Arm	Type	Receives
Full Coverage Rapid Palatal Expansion (FCRPE) group:	Active comparator	Device: Tooth Tissue Borne Rapid Palatal ExpansionImpressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of all maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.
Modified McNamara Rapid Palatal Expansion (MMRPE) Group:	Active comparator	Device: Tooth Tissue Borne Rapid Palatal ExpansionImpressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of the posterior maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.
Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group	Active comparator	Device: Tooth Bone Borne Rapid Palatal ExpansionThe MARPE appliance was composed of a central expansion jackscrew (Dentarum), 4 tubes, 2 bands on the upper first molars to facilitate placement of the appliance, and 1.5-mm diameter stainless steel arms extending to the premolar teeth. Soldered stainless steel tubes (internal diameter: 2.0 mm; external diameter: 3.0 mm; length: 2.0 mm) served as guides for miniscrew placement. The size of the screws (PSM) was chosen as 1.8 mm in diameter and 11 mm in length, considering the 2 mm height of the tubes, 1 to 2 mm gap between the appliance and the palate surface, 1 to 2 mm gingiva thickness, and 5 to 6 mm length required for the bicortical placement of the screw in the bone.
Control Group	No intervention	–A control group in the same age, without maxillary constriction was also added to our study.Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance were used. Polygraphy and rhinomanometry measurements were obtained at the beginning of the follow-up and at the end of the 4-month follow-up period.

Who may qualify

Ages: 14 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

With a unilateral or bilateral morphological lateral crossbite
Whose first molars and premolars had completely erupted at pretreatment
With maxillary constriction of more than 4 mm and less than 10 mm
Who were going through the post-pubertal growth spurt stage based on hand-wrist radiographs
Individuals with a body mass index of 18-24

Key exclusion criteria (4 listed)

craniofacial anomalies
compliance problems
systemic or genetic disease
previous orthodontic treatment history

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
Tooth Tissue Borne Rapid Palatal ExpansionIn all rapid palatal expansion groups, the appliances were cis bonded after being made by the same technician. The expansion screw was turned twice a day until the desired width was achieved.	Device	Full Coverage Rapid Palatal Expansion (FCRPE) group:, Modified McNamara Rapid Palatal Expansion (MMRPE) Group:
Tooth Bone Borne Rapid Palatal ExpansionAfter the Marpe appliance was attached, 4 miniscrews were applied to the midline of the palate with a miniscrew driver. The expansion screw was turned twice a day until the desired width was achieved.	Device	Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group

Primary outcome

Rhinomanometry Measurement Parameters (Pa/cm3/sn )
Time frame: up to 1 year
-Total Nasal Resistance(Pa/cm3/sn ): In our study, total nasal resistance was measured with a rhinomanometry device.
Polygraphy Measurement Parameters (event/hour)
Time frame: up to 1 year
- Apnea-Hypopnea Index (event/hour) : In our study, Apnea-Hypopnea Index(AHI) was measured with a polygraphy device. - Oxygen Desaturation index (De SPO2) : In our study, De SPO2 was measured with a polygraphy device.

2 secondary outcomes

Postero-anterior Measurement Parameters(mm)
Time frame: up to 1 year
Model Measurement Parameters(mm)
Time frame: up to 1 year

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 24 Aug 2023.
Background: PubMed 15782523Lagravere MO, Major PW, Flores-Mir C. Skeletal and dental changes with fixed slow maxillary expansion treatment: a systematic review. J Am Dent Assoc. 2005 Feb;136(2):194-9. doi: 10.14219/jada.archive.2005.0141.
Background: PubMed 20685540Lee KJ, Park YC, Park JY, Hwang WS. Miniscrew-assisted nonsurgical palatal expansion before orthognathic surgery for a patient with severe mandibular prognathism. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):830-9. doi: 10.1016/j.ajodo.2007.10.065.
Background: PubMed 21683264Seeberger R, Kater W, Schulte-Geers M, Davids R, Freier K, Thiele O. Changes after surgically-assisted maxillary expansion (SARME) to the dentoalveolar, palatal and nasal structures by using tooth-borne distraction devices. Br J Oral Maxillofac Surg. 2011 Jul;49(5):381-5. doi: 10.1016/j.bjoms.2010.05.015. Epub 2010 Jun 17.
Individual participant dataSharing planned: No

Related trials for Transverse Maxillary Deficiency

Not yet recruitingObservational study
Three-Dimensional Facial Soft Tissue Changes and Clinical Perception Following MARPE
Maxillary Transverse Deficiency
Not yet recruiting
Tooth-Borne (TBA) Versus Hybrid Expanders (HA) in Surgically Assisted Rapid Maxillary Expansion (SARME)
Maxillary Transverse Deficiency
Not yet recruiting
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Maxillary Transverse Deficiency, Rapid Maxillary Expansion
Active, not recruiting
Comparison of Laboratory-Fabricated and 3D-Printed Rapid Maxillary Expansion Appliances
Maxillary Constriction
Recruiting
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients

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.

Ahmet YAGCI, PROFESSOR study director

Erciyes University Faculty of Dentistry

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 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 24 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 Turkey (Türkiye). 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?

Rhinomanometry Measurement Parameters (Pa/cm3/sn ) (time frame: up to 1 year). 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 NCT06009796, which also lists 3 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 24 Aug 2023.