Face MaskNCT05913076

Class III Malocclusion and ALT-RAMEC

A study testing Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first group, Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group and Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third group in people with Face Mask and Rapid Maxillary Expansion, run by Trakya 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

Who is it for?: Ages 9 to 11 yearsHealthy volunteers can take part
Conditions the study is for: Face Mask, Rapid Maxillary Expansion, Maxillary Retrognathism
What is being tested?: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first group, Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group and Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 13 Jan 2012to 15 Aug 2012
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 9 to 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Maxillary retrognathia (SNA ≤ 79°)
Skeletal Class III malocclusion (ANB ≤ -1°)
Anterior cross-bite
Class III molar relationship
Horizontal growth pattern (SN/Go-Gn < 30°)

Who cannot join

Previous orthodontic treatment
Systemic disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Trakya University
Edirne, 22000

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effects of Alternating Rapid Maxillary Expansion and Facemask Use in Cases of Class III Malocclusion Caused by Maxillary Retrognathia- A Prospective, Randomized Clinical Trial

Diverse viewpoints exist regarding the correlation between the conventional rapid maxillary expansion (RME) and facemask approach and the alternative RME and facemask hybrid technique (Alt-RAMEC) in terms of the degree of maxillary protraction. The findings of the study may offer a novel approach to protocol selection based on the anomaly's degree of severity. The objective of this investigation is to assess and contrast the skeletal and dentoalveolar outcomes of three distinct Alt-RAMEC techniques.

Read the detailed description

Alternating rapid maxillary expansion and constriction (Alt-RAMEC) procedure is one of the most frequently used methods in the treatment of Class III cases caused by maxillary retrognathia. The objective of this investigation is to conduct a comparative analysis of the skeletal and dentofacial outcomes of three distinct techniques for maxillary protraction Following the primary recording, the patients were evaluated using bonded-type rapid maxillary expansion (RME) devices and three discrete Alt-RAMEC techniques (1, 3, and 5 weeks). Lateral cephalograms were obtained from a sample of 40 patients (18 males and 22 females) with a mean age of 10.64 ± 0.98. These images were taken both before (T1) and after the 6th month of facemask treatment (T2), and were subjected to total and local superimpositions. The Wilcoxon Sign, Kruskal-Wallis and Mann-Whitney U tests were used to evaluate the data.

Conditions: Face Mask, Rapid Maxillary Expansion, Maxillary Retrognathism
Being tested: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first group, Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group, Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third group

What participants receive

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

Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first groupDevice
Also called (Fabricated for every patient) Bonded-type Expansion Device
The study involved the fabrication of occlusal-coverage bonded type RME devices utilizing Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy). Each patient in Group 1 (classical RME method) was instructed to open Hyrax screw twice a day for a week. At the end of the respective periods (1 week), the screws were fixed with ligatures, and the patients were evaluated.
Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.
Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second groupDevice
Also called (Fabricated for every patient) Bonded-type Expansion Device
The same fabrication of occlusal-coverage bonded type RME devices were utilized Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy) in Group 2. Each patient in Group 2 (3-week Alt-RAMEC protocol), the patients were instructed to activate Hyrax screw twice a day for one week, close the screw for following week, and open the screw over the third week. At the end of the respective periods (3 weeks), the screws were fixed with ligatures, and the patients were evaluated.
Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.
Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third groupDevice
Also called (Fabricated for every patient) Bonded-type Expansion Device
The same fabrication of occlusal-coverage bonded type RME devices were utilized Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy) in Group 3. Each patient in Group 3 (5-week Alt-RAMEC protocol), the patients were instructed to activate Hyrax screw twice a day for one week, close the screw for following week, and open the screw over the third week. The aforementioned screw open-close procedure was implemented over a period of five weeks. At the end of the respective periods (5 weeks), the screws were fixed with ligatures, and the patients were evaluated.
Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.

Study groups in NCT05913076
Study group	Role	What they receive
Investigation of the Effects of Alt-RAMEC and Facemask 1 week Use in Class III Malocclusion	Experimental	A sample of 40 patients, consisting of 18 males and 22 females with a mean age of 10.64 ± 0.98, who were in the growth and developmental stage, were divided into three treatment groups. The formation of groups was carried out with the aim of achieving a near-equal distribution of male and female participants within each group, as indicated in Table 1. The first group comprised 14 patients, while the second and third groups consisted of 13 patients each. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1. Receives: Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first group
Investigation of the Effects of Alt-RAMEC and Facemask 3 week Use in Class III Malocclusion	Experimental	The second group comprised 13 patients who were in the growth and developmental stage. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1. Receives: Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group
Investigation of the Effects of Alt-RAMEC and Facemask 5 week Use in Class III Malocclusion	Experimental	The third group comprised 13 patients who were in the growth and developmental stage. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1. Receives: Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third group

What is being measured

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

Evaluation of Skeletal, Dental, and Soft Tissue Angular Measurements
Changes at the maxillary advancement, teeth positions and soft tissues amount were assessed in angular level.
Skeletal measurements:
Angular measurements: SNA (°), SNB (°), SN/S-Gn (Y-axis)(°), SN/Go-Gn (°), Ar-Go-Gn (°), SN/Go-Ar (°), and ANB (°) were measured.
Dental measurements:
Angular measurements: U1 to MaxP (°) for maxillary dentoalveolar measurements; L1-MandP (°) for mandibular dentoalveolar measurements; U1-L1 (°) for interdental measurements were performed.
Soft tissue measurements: Changes at the upper and lower lip assessed.
Angular measurements: G-Sn-Pg' (°), Nasolabial angle (°), and Labiomental angle (°) were measured.
Measured: 6 months

Secondary outcomes (1)

Evaluation of Skeletal, Dental, and Soft Tissue Millimetrical Measurements
Changes at the maxillary advancement, teeth positions and soft tissues amount were assessed in millimetrical level.
Skeletal measurements:
Millimetrical measurements: Co-A (mm) for maxillary skeletal measurement, Co-B (mm) for mandibular skeletal measurement, N-Me (mm), N-ANS (mm), and ANS-Me (mm) for maxillomandibular skeletal measurements were performed.
Dental measurements:
Millimetrical measurements: U1-MaxP (mm), U1-MaxVP (mm), U6-MaxP (mm), U6-MaxVP (mm) for maxillary dentoalveolar measurements; L1-MandP (mm), L1-MandVP (mm), L6-MandP (mm), L6-MandVP (mm) for mandibular dentoalveolar measurements; Overbite (mm) and overjet (mm) for interdental measurements were performed.
Soft tissue measurements: Changes at the upper and lower lip assessed.
Millimetrical measurements: Ls-S (mm) and Li-S (mm) were measured.
Measured: 6 months

Timeline

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

13 Jan 201215 Aug 2012

First posted22 Jun 2023
Study start13 Jan 2012
Primary completion15 Jul 2012
Study completion15 Aug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Face MaskStudies 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: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05913076
Sponsor's protocol ID: facemasktrakya1234
Status last verified: Jun 2023
First submitted: 17 May 2023
Last updated: 22 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 Face Mask trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effects of Alternating Rapid Maxillary Expansion and Facemask Use in Cases of Class III Malocclusion Caused by Maxillary Retrognathia- A Prospective, Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05913076
Acronym / sponsor ID: facemasktrakya1234
Conditions: Face Mask, Rapid Maxillary Expansion, Maxillary Retrognathism
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Trakya UniversityUniversity, hospital or other
Collaborators: Istanbul University
Study start: 13 Jan 2012 (actual)
Primary completion: 15 Jul 2012 (actual)
Study completion: 15 Aug 2012 (actual)
First posted: 22 Jun 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: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Investigation of the Effects of Alt-RAMEC and Facemask 1 week Use in Class III Malocclusion	Experimental	Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first groupA sample of 40 patients, consisting of 18 males and 22 females with a mean age of 10.64 ± 0.98, who were in the growth and developmental stage, were divided into three treatment groups. The formation of groups was carried out with the aim of achieving a near-equal distribution of male and female participants within each group, as indicated in Table 1. The first group comprised 14 patients, while the second and third groups consisted of 13 patients each. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1.
Investigation of the Effects of Alt-RAMEC and Facemask 3 week Use in Class III Malocclusion	Experimental	Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second groupThe second group comprised 13 patients who were in the growth and developmental stage. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1.
Investigation of the Effects of Alt-RAMEC and Facemask 5 week Use in Class III Malocclusion	Experimental	Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third groupThe third group comprised 13 patients who were in the growth and developmental stage. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1.

Who may qualify

Ages: 9 to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Maxillary retrognathia (SNA ≤ 79°)
Skeletal Class III malocclusion (ANB ≤ -1°)
Anterior cross-bite
Class III molar relationship
Horizontal growth pattern (SN/Go-Gn < 30°)

Key exclusion criteria (2 listed)

Previous orthodontic treatment
Systemic disorders

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
Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first groupAlso: (Fabricated for every patient) Bonded-type Expansion DeviceThe study involved the fabrication of occlusal-coverage bonded type RME devices utilizing Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy). Each patient in Group 1 (classical RME method) was instructed to open Hyrax screw twice a day for a week. At the end of the respective periods (1 week), the screws were fixed with ligatures, and the patients were evaluated. Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.	Device	Investigation of the Effects of Alt-RAMEC and Facemask 1 week Use in Class III Malocclusion
Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second groupAlso: (Fabricated for every patient) Bonded-type Expansion DeviceThe same fabrication of occlusal-coverage bonded type RME devices were utilized Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy) in Group 2. Each patient in Group 2 (3-week Alt-RAMEC protocol), the patients were instructed to activate Hyrax screw twice a day for one week, close the screw for following week, and open the screw over the third week. At the end of the respective periods (3 weeks), the screws were fixed with ligatures, and the patients were evaluated. Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.	Device	Investigation of the Effects of Alt-RAMEC and Facemask 3 week Use in Class III Malocclusion
Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third groupAlso: (Fabricated for every patient) Bonded-type Expansion DeviceThe same fabrication of occlusal-coverage bonded type RME devices were utilized Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy) in Group 3. Each patient in Group 3 (5-week Alt-RAMEC protocol), the patients were instructed to activate Hyrax screw twice a day for one week, close the screw for following week, and open the screw over the third week. The aforementioned screw open-close procedure was implemented over a period of five weeks. At the end of the respective periods (5 weeks), the screws were fixed with ligatures, and the patients were evaluated. Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.	Device	Investigation of the Effects of Alt-RAMEC and Facemask 5 week Use in Class III Malocclusion

Primary outcome

Evaluation of Skeletal, Dental, and Soft Tissue Angular Measurements
Time frame: 6 months
Changes at the maxillary advancement, teeth positions and soft tissues amount were assessed in angular level. Skeletal measurements: Angular measurements: SNA (°), SNB (°), SN/S-Gn (Y-axis)(°), SN/Go-Gn (°), Ar-Go-Gn (°), SN/Go-Ar (°), and ANB (°) were measured. Dental measurements: Angular measurements: U1 to MaxP (°) for maxillary dentoalveolar measurements; L1-MandP (°) for mandibular dentoalveolar measurements; U1-L1 (°) for interdental measurements were performed. Soft tissue measurements: Changes at the upper and lower lip assessed. Angular measurements: G-Sn-Pg' (°), Nasolabial angle (°), and Labiomental angle (°) were measured.

1 secondary outcome

Evaluation of Skeletal, Dental, and Soft Tissue Millimetrical Measurements
Time frame: 6 months

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 22 Jun 2023.
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.

Nilüfer Yılmaz Öğütlü, Dr. study director

Istanbul University

Gülsün Külekçi Çakan principal investigator

Private Practitioner

Hülya Kılıçoğlu, Prof. Dr. study chair

Istanbul 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 5 inclusion and 2 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 22 Jun 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?

Evaluation of Skeletal, Dental, and Soft Tissue Angular Measurements (time frame: 6 months). 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 NCT05913076.

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 22 Jun 2023.