Malocclusion, Angle Class IIINCT06244563
Evaluation of Different Anchorage-supported Appliances and Expansion Procedures for Face Mask Treatment
A study testing Face mask with Hybrid-Hyrax, Face mask with Bonded RME and Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC) in people with Malocclusion, Angle Class III, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess and compare the effect of two appliances (Hybrid-Hyrax expander/ Bonded rapid maxillary expander (RME)) supported by different anchorage units and two different expansion procedures (routine rapid maxillary expansion protocol (routine)/ alternative rapid expansion and… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class III
- What is being tested?
- Face mask with Hybrid-Hyrax, Face mask with Bonded RME and Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2022to 9 Jun 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Skeletal class III
- Prepubertal growth stage
- Reverse overjet
Who cannot join
- Previous orthodontic treatment history
- Patients with craniofacial abnormalities and syndromes.
- Systemic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Sehitkamil, 27310
About this study
Official title: Evaluation of the Efficacy of Different Anchorage-supported Appliances and Different Expansion Procedures for Face Mask Treatment in Prepubertal Children
The purpose of this study is to assess and compare the effect of two appliances (Hybrid-Hyrax expander/ Bonded rapid maxillary expander (RME)) supported by different anchorage units and two different expansion procedures (routine rapid maxillary expansion protocol (routine)/ alternative rapid expansion and constriction protocol (alt-RAMEC)) on maxillary protraction during face mask (FM) treatment.
Read the detailed description
Face mask therapy is an effective method in the treatment of class III malocclusions due to maxillary insufficiency. In face mask treatment, various intraoral devices are used to transmit protraction forces to the maxilla. According to the anchorage unit, these appliances are divided into tooth-supported and bone-supported. The traditional bonded rapid maxillary expander (RME) is a tooth-supported appliance that allows expansion and is generally used with face masks. However, it causes many side effects due to the transmission of protraction forces through the teeth. Hybrid appliances supported by skeletal and dental anchorage may be preferred over bonded RME in the maxilla for face mask treatment based on their lower dental side effects and high skeletal contribution.
Before transferring the protraction forces to the maxilla using a face mask, expansion is first performed with intraoral devices according to the patient's needs. For this purpose, two different expansion procedures are currently used: routine rapid maxillary expansion (routine) and alternative rapid maxillary expansion and contraction (alt-RAMEC). In the routine rapid maxillary expansion procedure, the expander screw is turned twice a day until the expansion phase is complete. Unlike the routine procedure, in the alt-RAMEC procedure, each week of expansion is followed by a week of contraction. The duration of the expansion-contraction process varies between 7-9 weeks, depending on the patient's need for expansion. These opening and closing phases are increased maxillary protraction by loosening the intermaxillary sutures.
The main purpose of this study is to compare the effects of different combinations of appliances and procedures on maxillary protraction during face mask treatment and determine the most powerful method. Sixty patients who were planned to apply face mask treatment were included in the study and divided into four groups (n=15) (Group 1: Hybrid-Hyrax expander and alt-RAMEC procedure, Group 2: Bonded RME and alt-RAMEC procedure, group 3: Hybrid Hyrax expander and routine protocol, group 4: Bonded RME and routine protocol). To investigate skeletal changes, lateral cephalometric films were taken before (T0) and after (T1) treatment. Dolphin Imaging software and AutoCad 2023 software were used for cephalometric measurements.
- Conditions
- Malocclusion, Angle Class III
- Being tested
- Face mask with Hybrid-Hyrax, Face mask with Bonded RME, Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC), Routine Rapid Maxillary Expansion Protocol
- Keywords
- facemask treatment
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face mask with Hybrid-HyraxDevice
Participants were treated with face mask using a Hybrid-Hyrax appliance as an anchor in the maxillary arch. The anchorage of hybrid-hyrax appliance was provided by bands adapted to the maxillary first permanent molars and two mini screws in the anterior palate. Force transmission was achieved using intermaxillary elastics that were connected to the face mask arms from the hooks of the hybrid-hyrax appliance in the maxillary canine region.
Face mask with Bonded RMEDevice
Participants were treated with face mask using a bonded RME appliance as an anchor in the maxillary arch. The anchorage of bonded RME appliance was provided by maxillary posterior teeth covered with acrylic cap. Force transmission was achieved using intermaxillary elastics that were connected to the face mask arms from the hooks of the bonded RME in the maxillary canine region.
Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC)Procedure or surgery
In the groups that started with the Alt-Ramec protocol, the parents expanded the appliance screw twice a day in the first week and closed it in the opposite direction in the following week. This process was continued for 7-9 weeks according to the patient's need for expansion.
Routine Rapid Maxillary Expansion ProtocolProcedure or surgery
In the groups that started with the routine protocol, parents activated the expansion screw twice a day for 1-2 weeks, depending on the patient's need for expansion.
| Study group | Role | What they receive |
|---|---|---|
| Face mask with Hybrid-Hyrax and Alt-RAMEC procedure | Experimental | The experimental group was comprised of 15 patients submitted to the alternate rapid maxillary expansion and constriction (alt-RAMEC) procedure for expansion protocol with a hybrid-hyrax expander as anchorage in the maxillary arch. The Face mask was used. Receives: Device: Face mask with Hybrid-Hyrax; Procedure: Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC) |
| Face mask with Bonded RME and Alt-RAMEC procedure | Experimental | The experimental group was comprised of 15 patients submitted to the alt-RAMEC procedure for expansion protocol with a bonded RME as anchorage in the maxillary arch. The Face mask was used. Receives: Device: Face mask with Bonded RME; Procedure: Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC) |
| Face mask with Hybrid-Hyrax and routine protocol | Experimental | The experimental group was comprised of 15 patients submitted to routine palatal expansion procedure (routine) with a hybrid-hyrax expander as anchorage in the maxillary arch. The Face mask was used. Receives: Device: Face mask with Hybrid-Hyrax; Procedure: Routine Rapid Maxillary Expansion Protocol |
| Face mask with Bonded RME and routine protocol | Active comparator | The active comparator group was comprised of 15 patients who submitted to the routine expansion procedure with a bonded RME as anchorage in the maxillary arch. The Face mask was used. Receives: Device: Face mask with Bonded RME; Procedure: Routine Rapid Maxillary Expansion Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Skeletal and Dental Changes in Millimetric Measurements
Skeletal and dental changes in the maxilla and mandible were evaluated in millimetres using lateral radiographs taken before and after treatment.
To determine skeletal changes A-VRP (mm), Co-A (mm), A-HRP (mm), Pog-VRP (mm), Co-Gn (mm) and WITS (mm) values were measured.
To determine dental changes U1-VRP(mm), U1-HRP(mm), U6-VRP(mm), U6-HRP(mm), and L1-VRP(mm) values were measured.
Measured: 9 month
Secondary outcomes (1)
Evaluation of Skeletal and Dental Changes in Angular Measurements
Skeletal and dental changes in the maxilla and mandible were evaluated in angularly using lateral radiographs taken before and after treatment.
To determine skeletal changes, the following angles were measured: SNA (°), SNB (°), ANB (°), SN-PP (°), SN-MP (°), PP-MP (°) and Ar-Go-Me (°).
To determine dental changes, the following angles were measured: U1-SN (°) and IMPA (°).
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start8 Jun 2022
- Primary completion10 Apr 2023
- Study completion9 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIIStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Ergul, University of Gaziantep
- Investigators
- Aysegul Gulec, PhD, Study chair, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244563
- Sponsor's protocol ID
- 102
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Different Anchorage-supported Appliances and Different Expansion Procedures for Face Mask Treatment in Prepubertal Children
- ClinicalTrials.gov ID
- NCT06244563
- Acronym / sponsor ID
- 102
- Conditions
- Malocclusion, Angle Class III
- Keywords
- facemask treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 6 Feb 2024 (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.
The purpose of this study is to assess and compare the effect of two appliances (Hybrid-Hyrax expander/ Bonded rapid maxillary expander (RME)) supported by different anchorage units and two different expansion procedures (routine rapid maxillary expansion protocol (routine)/ alternative rapid expansion and constriction protocol (alt-RAMEC)) on maxillary protraction during face mask (FM) treatment.
Detailed description
Face mask therapy is an effective method in the treatment of class III malocclusions due to maxillary insufficiency. In face mask treatment, various intraoral devices are used to transmit protraction forces to the maxilla. According to the anchorage unit, these appliances are divided into tooth-supported and bone-supported. The traditional bonded rapid maxillary expander (RME) is a tooth-supported appliance that allows expansion and is generally used with face masks. However, it causes many side effects due to the transmission of protraction forces through the teeth. Hybrid appliances supported by skeletal and dental anchorage may be preferred over bonded RME in the maxilla for face mask treatment based on their lower dental side effects and high skeletal contribution.
Before transferring the protraction forces to the maxilla using a face mask, expansion is first performed with intraoral devices according to the patient's needs. For this purpose, two different expansion procedures are currently used: routine rapid maxillary expansion (routine) and alternative rapid maxillary expansion and contraction (alt-RAMEC). In the routine rapid maxillary expansion procedure, the expander screw is turned twice a day until the expansion phase is complete. Unlike the routine procedure, in the alt-RAMEC procedure, each week of expansion is followed by a week of contraction. The duration of the expansion-contraction process varies between 7-9 weeks, depending on the patient's need for expansion. These opening and closing phases are increased maxillary protraction by loosening the intermaxillary sutures.
The main purpose of this study is to compare the effects of different combinations of appliances and procedures on maxillary protraction during face mask treatment and determine the most powerful method. Sixty patients who were planned to apply face mask treatment were included in the study and divided into four groups (n=15) (Group 1: Hybrid-Hyrax expander and alt-RAMEC procedure, Group 2: Bonded RME and alt-RAMEC procedure, group 3: Hybrid Hyrax expander and routine protocol, group 4: Bonded RME and routine protocol). To investigate skeletal changes, lateral cephalometric films were taken before (T0) and after (T1) treatment. Dolphin Imaging software and AutoCad 2023 software were used for cephalometric measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Face mask with Hybrid-Hyrax and Alt-RAMEC procedure | Experimental | Device: Face mask with Hybrid-Hyrax, Procedure: Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC)The experimental group was comprised of 15 patients submitted to the alternate rapid maxillary expansion and constriction (alt-RAMEC) procedure for expansion protocol with a hybrid-hyrax expander as anchorage in the maxillary arch. The Face mask was used. |
| Face mask with Bonded RME and Alt-RAMEC procedure | Experimental | Device: Face mask with Bonded RME, Procedure: Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC)The experimental group was comprised of 15 patients submitted to the alt-RAMEC procedure for expansion protocol with a bonded RME as anchorage in the maxillary arch. The Face mask was used. |
| Face mask with Hybrid-Hyrax and routine protocol | Experimental | Device: Face mask with Hybrid-Hyrax, Procedure: Routine Rapid Maxillary Expansion ProtocolThe experimental group was comprised of 15 patients submitted to routine palatal expansion procedure (routine) with a hybrid-hyrax expander as anchorage in the maxillary arch. The Face mask was used. |
| Face mask with Bonded RME and routine protocol | Active comparator | Device: Face mask with Bonded RME, Procedure: Routine Rapid Maxillary Expansion ProtocolThe active comparator group was comprised of 15 patients who submitted to the routine expansion procedure with a bonded RME as anchorage in the maxillary arch. The Face mask was used. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Skeletal class III
- Prepubertal growth stage
- Reverse overjet
Key exclusion criteria (3 listed)
- Previous orthodontic treatment history
- Patients with craniofacial abnormalities and syndromes.
- Systemic diseases
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 |
|---|---|---|
| Face mask with Hybrid-HyraxParticipants were treated with face mask using a Hybrid-Hyrax appliance as an anchor in the maxillary arch. The anchorage of hybrid-hyrax appliance was provided by bands adapted to the maxillary first permanent molars and two mini screws in the anterior palate. Force transmission was achieved using intermaxillary elastics that were connected to the face mask arms from the hooks of the hybrid-hyrax appliance in the maxillary canine region. | Device | Face mask with Hybrid-Hyrax and Alt-RAMEC procedure, Face mask with Hybrid-Hyrax and routine protocol |
| Face mask with Bonded RMEParticipants were treated with face mask using a bonded RME appliance as an anchor in the maxillary arch. The anchorage of bonded RME appliance was provided by maxillary posterior teeth covered with acrylic cap. Force transmission was achieved using intermaxillary elastics that were connected to the face mask arms from the hooks of the bonded RME in the maxillary canine region. | Device | Face mask with Bonded RME and Alt-RAMEC procedure, Face mask with Bonded RME and routine protocol |
| Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC)In the groups that started with the Alt-Ramec protocol, the parents expanded the appliance screw twice a day in the first week and closed it in the opposite direction in the following week. This process was continued for 7-9 weeks according to the patient's need for expansion. | Procedure or surgery | Face mask with Bonded RME and Alt-RAMEC procedure, Face mask with Hybrid-Hyrax and Alt-RAMEC procedure |
| Routine Rapid Maxillary Expansion ProtocolIn the groups that started with the routine protocol, parents activated the expansion screw twice a day for 1-2 weeks, depending on the patient's need for expansion. | Procedure or surgery | Face mask with Bonded RME and routine protocol, Face mask with Hybrid-Hyrax and routine protocol |
Primary outcome
Evaluation of Skeletal and Dental Changes in Millimetric Measurements
Time frame: 9 month
Skeletal and dental changes in the maxilla and mandible were evaluated in millimetres using lateral radiographs taken before and after treatment. To determine skeletal changes A-VRP (mm), Co-A (mm), A-HRP (mm), Pog-VRP (mm), Co-Gn (mm) and WITS (mm) values were measured. To determine dental changes U1-VRP(mm), U1-HRP(mm), U6-VRP(mm), U6-HRP(mm), and L1-VRP(mm) values were measured.
1 secondary outcome
Evaluation of Skeletal and Dental Changes in Angular Measurements
Time frame: 9 month
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 6 Feb 2024.
- 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.
Aysegul Gulec, PhD study chair
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face mask with Hybrid-Hyrax, Face mask with Bonded RME and Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC) in people with Malocclusion, Angle Class III, run by University of Gaziantep at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 6 Feb 2024. 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 and Dental Changes in Millimetric Measurements (time frame: 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2024.