Evaluation of Different Anchorage-supported Appliances and Expansion Procedures for Face Mask Treatment
NCT ID: NCT06244563
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2022-06-08
2023-06-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Skeletal Anchorage Versus Conventional Tooth-Borne Face Mask Therapy Following the Alt-RAMEC Protocol
NCT07279662
Comparative 3D Assessment of Class III Malocclusion Treatments
NCT07179354
Efficacy of RME and Facemask Therapy for Class III Malocclusion
NCT07053683
Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
NCT04863404
Evaluation of the Effect of Three Types of Rapid Maxillary Expanders (Conventional, Hybrid and MSE)
NCT05446714
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Face mask with Hybrid-Hyrax and Alt-RAMEC procedure
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 Hybrid-Hyrax
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.
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.
Face mask with Bonded RME and Alt-RAMEC procedure
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 Bonded RME
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)
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.
Face mask with Hybrid-Hyrax and routine protocol
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.
Face mask with Hybrid-Hyrax
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.
Routine Rapid Maxillary Expansion Protocol
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.
Face mask with Bonded RME and routine 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.
Face mask with Bonded RME
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.
Routine Rapid Maxillary Expansion Protocol
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Face mask with Hybrid-Hyrax
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 RME
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)
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 Protocol
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Prepubertal growth stage
* Reverse overjet
Exclusion Criteria
* Patients with craniofacial abnormalities and syndromes.
* Systemic diseases
8 Years
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Gaziantep
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tugce Ergul
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aysegul Gulec, PhD
Role: STUDY_CHAIR
University of Gaziantep
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gaziantep University
Gaziantep, Sehitkamil, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
102
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.