An interventional study of Face mask with Hybrid-Hyrax and Face mask with Bonded RME in Malocclusion, Angle Class III, sponsored by University of Gaziantep. Completed at 1 site in Turkey. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by University of Gaziantep · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's enrollment of 60 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
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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.
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 alt-RAMEC procedure for expansion protocol with a bonded RME as anchorage in the maxillary arch. The Face mask was used.
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 routine palatal expansion procedure (routine) with a hybrid-hyrax expander as anchorage in the maxillary arch. The Face mask was used.
Device: Face mask with Hybrid-Hyrax · Procedure: Routine Rapid Maxillary Expansion Protocol
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.
Device: Face mask with Bonded RME · Procedure: Routine Rapid Maxillary Expansion Protocol
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.
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.
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.
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.
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.
Time frame: 9 month
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 (°).
Time frame: 9 month
Plan to share: No
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Ran from Jun 2022 to primary completion in Apr 2023, 10 months.
Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 10 months is below that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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