Evaluation of Different Anchorage-supported Appliances and Expansion Procedures for Face Mask Treatment

February 2, 2024 updated by: Tugce Ergul, University of Gaziantep

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Sehitkamil
      • Gaziantep, Sehitkamil, Turkey, 27310
        • Gaziantep University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Skeletal class III
  • Prepubertal growth stage
  • Reverse overjet

Exclusion Criteria:

  • Previous orthodontic treatment history
  • Patients with craniofacial abnormalities and syndromes.
  • Systemic diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Procedure: 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.
Experimental: 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.
Procedure: 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.
Device: 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.
Experimental: 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.
Device: 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.
Procedure: 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.
Active Comparator: 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.
Device: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Skeletal and Dental Changes in Angular Measurements
Time Frame: 9 month

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 (°).
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gaziantep

Investigators

  • Study Chair: Aysegul Gulec, PhD, University of Gaziantep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2022

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

June 9, 2023

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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