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

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class III
• Interventions: Device: Face mask with Hybrid-Hyrax; Device: Face mask with Bonded RME; Procedure: Alternative Rapid Maxillary Expansion and Contraction Protocol (Alt-RAMEC); Procedure: Routine Rapid Maxillary Expansion Protocol

• Registration Number: NCT06244563
• Lead Sponsor: University of Gaziantep

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.

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 Timeline

• Study Start: 2022-06-08
• Primary Completion: 2023-04-10
• Study Completion: 2023-06-09
• Study First Submitted: 2024-01-10
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face mask with Hybrid-Hyrax and Alt-RAMEC procedure	Face mask with Hybrid-Hyrax	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	Face mask with Bonded RME	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 Alt-RAMEC 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 Hybrid-Hyrax and routine protocol	Face mask with Hybrid-Hyrax	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 and routine protocol	Routine Rapid Maxillary Expansion 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 Bonded RME and routine protocol	Face mask with Bonded RME	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 and Alt-RAMEC 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 Bonded RME and routine protocol	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of Skeletal and Dental Changes in Millimetric Measurements	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Skeletal and Dental Changes in Angular Measurements	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 (°).

Trial Locations

Locations (1)

Gaziantep University; 🇹🇷 Gaziantep, Sehitkamil, Turkey