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Effects of Conventional Versus Skeletally Anchored Facemask in Treatment of the Prepubertal Skeletal Class III Patients

Primary Purpose

Maxillary Deficiency, Maxillary Retrusion

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Maxillary protraction
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Deficiency

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Growing Class III patients with a prepubertal stage of skeletal maturity according to the cervical vertebral maturation method.
  • Skeletal Class III malocclusion with maxillary deficiency (ANB, <0°; N perp-A<1mm) with or without mild mandibular prognathism.
  • Late mixed or early permanent dentition at the start of treatment characterized by a Wits appraisal of -1 mm or less and an Angle Class III molar relationship or anterior crossbite.
  • Vertically normal growth pattern determined by cephalometric radiographs.
  • Patients are free from developmental or congenital conditions such as cleft lip/palate or other craniofacial anomalies.
  • No previous orthodontic treatment.

Exclusion Criteria:

  • Poor oral hygiene or periodontally compromised patient.
  • Patients with craniofacial anomalies or previous history of trauma, bruxism, or parafunctions.
  • Previous orthodontic treatment.

Sites / Locations

  • Al-azhar university- Faculty of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional dentally anchored maxillary protraction

skeletally anchored maxillary protraction

Arm Description

A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch). a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side.

A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in addition, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side.

Outcomes

Primary Outcome Measures

midfacial length
linear distance between condylon and A points

Secondary Outcome Measures

Full Information

First Posted
October 11, 2021
Last Updated
November 27, 2021
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05089396
Brief Title
Effects of Conventional Versus Skeletally Anchored Facemask in Treatment of the Prepubertal Skeletal Class III Patients
Official Title
Assessment of Dentoskeletal Effects Concomitant With Skeletally Anchored Maxillary Protraction in Orthodontic Skeletal Class III Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study will be directed to the assessment of dentoskeletal effects concomitant with skeletally anchored maxillary protraction in orthodontic skeletal Class III patients.
Detailed Description
Skeletal Class III is a challenging problem that is confronting orthodontists in their everyday orthodontic practice. The prevalence of this malocclusion varies globally among and within populations with the greatest incidence among Asian countries. It was reported that Class III malocclusion represents 3.98% and 5.93% of malocclusions in mixed and permanent dentitions respectively. Among Egyptians, the prevalence of Class III malocclusion during mixed dentition was found to be 5.9 % according to the sample studied by Fsifis et al. Different skeletal components contribute to the development of the classic Class III with convex or straight profiles. These components are either maxillary retrognathism, mandibular prognathism relative to other craniofacial structures, or even a combination of them. According to the sample studied by Ellis and Macnamara, they found 65% to 67% of skeletal Class III was due to maxillary skeletal retrusion. The growth and severity of the sagittal skeletal discrepancy dictate the possible treatment modalities. On one hand, Growth modification is indicated in individuals who have not reached the growth spurt yet. On the other hand, cessation of growth leaves only orthodontic camouflage and orthognathic surgery as treatment options, the severity of the anteroposterior discrepancy and dental compensation determine which of them gives the best clinical results. The most common approach for the treatment of growing Class III patients with maxillary retrognathism is the facemask (FM) accompanied by rapid maxillary expansion (RME). RME was claimed to open the midpalatal suture and affect the other nine sutures adjacent to the maxilla. Accordingly, it is said to facilitate the orthopedic effect of the facemask. However, a meta-analysis concluded that treatment with facemask with or without RME is clinically effective with a nonsignificant difference. Forces from protraction facemask are applied to dental structures so, it has side effects as mesial movement and extrusion of maxillary molars, proclination of upper incisors, retroclination of mandibular incisors, backward rotation of the mandible, and increase in the lower facial height. These side effects might be desirable or undesirable according to the clinical situation. Maximizing skeletal effects and minimizing dental effects will reduce the tendency for relapse and might be a desirable clinical outcome. For this purpose, in 1985 Kokich et al used ankylosed canines as a form of absolute anchorage for maxillary protraction. The advent of temporary anchorage devices (TADs) led to many reports with skeletally anchored maxillary protraction, Singer et al, Enacar et al, Hong et al, and Kircelli et al. This was followed by several studies applying facemask to miniplates at the zygomatic buttress, lateral nasal wall, and miniscrews (MS) in the zygomatic buttress, or in the palate. Consequently, the present study will be directed to evaluate the effects of skeletally anchored maxillary protraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Deficiency, Maxillary Retrusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional dentally anchored maxillary protraction
Arm Type
Active Comparator
Arm Description
A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch). a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side.
Arm Title
skeletally anchored maxillary protraction
Arm Type
Experimental
Arm Description
A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in addition, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side.
Intervention Type
Other
Intervention Name(s)
Maxillary protraction
Intervention Description
A petit facemask will be used for maxillary protraction along with a facemask splint (two acrylic bite blocks connected through a transpalatal arch) in the active comparator group. in the experimental group, two miniscrews will be inserted in the anterior region of the palate one on each side of the midline to provide skeletal anchorage for the facemask splint. in both groups, a force of 380 gm to 400 gm will be applied through the extra-oral elastics the will be attached to the facemask on one side and to the facemask splint on the other side.
Primary Outcome Measure Information:
Title
midfacial length
Description
linear distance between condylon and A points
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Growing Class III patients with a prepubertal stage of skeletal maturity according to the cervical vertebral maturation method. Skeletal Class III malocclusion with maxillary deficiency (ANB, <0°; N perp-A<1mm) with or without mild mandibular prognathism. Late mixed or early permanent dentition at the start of treatment characterized by a Wits appraisal of -1 mm or less and an Angle Class III molar relationship or anterior crossbite. Vertically normal growth pattern determined by cephalometric radiographs. Patients are free from developmental or congenital conditions such as cleft lip/palate or other craniofacial anomalies. No previous orthodontic treatment. Exclusion Criteria: Poor oral hygiene or periodontally compromised patient. Patients with craniofacial anomalies or previous history of trauma, bruxism, or parafunctions. Previous orthodontic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Embaby, BDS
Phone
00201016579279
Email
amrembaby.209@azhar.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Farouk Husssein, professor and chairman
Phone
00201005239280
Email
dr.farokahmed@azhar.edu.eg
Facility Information:
Facility Name
Al-azhar university- Faculty of Dental Medicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31398066
Citation
Seiryu M, Ida H, Mayama A, Sasaki S, Sasaki S, Deguchi T, Takano-Yamamoto T. A comparative assessment of orthodontic treatment outcomes of mild skeletal Class III malocclusion between facemask and facemask in combination with a miniscrew for anchorage in growing patients: A single-center, prospective randomized controlled trial. Angle Orthod. 2020 Jan;90(1):3-12. doi: 10.2319/101718-750.1. Epub 2019 Aug 12.
Results Reference
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Effects of Conventional Versus Skeletally Anchored Facemask in Treatment of the Prepubertal Skeletal Class III Patients

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