Evaluation of Different Anchorage-supported Appliances and Expansion Procedures for Face Mask Treatment
Evaluation of the Efficacy of Different Anchorage-supported Appliances and Different Expansion Procedures for Face Mask Treatment in Prepubertal Children
1 other identifier
interventional
60
1 country
1
Brief 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 constriction protocol (alt-RAMEC)) on maxillary protraction during face mask (FM) treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2023
CompletedFirst Submitted
Initial submission to the registry
January 10, 2024
CompletedFirst Posted
Study publicly available on registry
February 6, 2024
CompletedFebruary 6, 2024
February 1, 2024
10 months
January 10, 2024
February 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
9 month
Secondary Outcomes (1)
Evaluation of Skeletal and Dental Changes in Angular Measurements
9 month
Study Arms (4)
Face mask with Hybrid-Hyrax and Alt-RAMEC procedure
EXPERIMENTALThe 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
EXPERIMENTALThe 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
EXPERIMENTALThe 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 COMPARATORThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Skeletal class III
- Prepubertal growth stage
- Reverse overjet
You may not qualify if:
- Previous orthodontic treatment history
- Patients with craniofacial abnormalities and syndromes.
- Systemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziantep University
Gaziantep, Sehitkamil, 27310, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aysegul Gulec, PhD
University of Gaziantep
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 10, 2024
First Posted
February 6, 2024
Study Start
June 8, 2022
Primary Completion
April 10, 2023
Study Completion
June 9, 2023
Last Updated
February 6, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share