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

NCT05089396 | Unknown

• 1 other identifier: SA maxillary protraction
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Deficiency; Maxillary Retrusion

Outcome Measures

Primary Outcomes (1)

• midfacial length

  linear distance between condylon and A points

  1 year

Study Arms (2)

conventional dentally anchored maxillary protraction

ACTIVE COMPARATOR

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.

Other: Maxillary protraction

skeletally anchored maxillary protraction

EXPERIMENTAL

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.

Other: Maxillary protraction

Interventions

Maxillary protraction OTHER

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.

conventional dentally anchored maxillary protraction; skeletally anchored maxillary protraction

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-azhar university- Faculty of Dental Medicine

Cairo, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 31398066 BACKGROUND

MeSH Terms

Conditions

Retrognathia

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Amr Embaby, BDS

CONTACT

00201016579279; amrembaby.209@azhar.edu.eg

Farouk Husssein, professor and chairman

CONTACT

00201005239280; dr.farokahmed@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: November 22, 2021
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)