The Use of Statically Determinate Force System in Closure of Anterior Open Bite in Adults.

Dentoalveolar and Skeletal Changes Associated With a Statically Determinate Force System in the Closure of Anterior Open Bite in Adults: A Single-arm Clinical Trial

The aim of the current study was to evaluate and quantify the cephalometric changes produced by maxillary and mandibular extrusion arches in closure of anterior open bite in non-growing patients.

Study Overview

• Status: Completed
• Conditions: Anterior Openbite
• Intervention / Treatment: Device: Extrusion arch

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 30 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients with anterior open bites more than 1 mm, permanent dentition except for the third molars which were extracted if erupted

Exclusion Criteria:

• Frankfort to mandibular plane angle > 40
• congenital craniofacial malformations or temporomandibular joint disorders,
• patients with severe gum show during smiling or increased incisal show at rest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Extrusion arch; Hand made stainless steel extrusion arch wire (0.016x0.22")	Device: Extrusion arch; one couple force system is applied; a custom-made extrusion wire from 0.016x0.022 stainless steel wire with helical bends placed 2-5 mm mesial to the molar tube placed in the upper and lower arches and tied distal to the lateral incisors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
angular and vertical linear effects on incisors	Extrusion of upper and lower incisors measured from: incisal edge, centroid point and apex to the palatal and mandibular planes for the upper and lower incisors respectively. Angles between long axis of upper incisor to SN plane and palatal plane, Angle between long axis of lower incisor and mandibular plane using lateral cephalometric xray	up to 6 months
angular and vertical linear effects on first molars	For the first molars: Angular measurements between the long axis of the measuring jigs and the palatal plane and mandibular plane for the upper and lower molars, respectively. Vertical measurements: perpendicular vertical distance from the measuring jigs to the palatal and mandibular planes for the upper and lower molars, respectively, using lateral cephalometric xray.	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the SN' to Mandibular plane angle	measuring the change in the angle between SN' to Mandibular plane angle, using lateral cephalometric xray	up to 6 months
change in the palatal to Mandibular plane angle	measuring the change in the angle between the palatal to Mandibular plane angle, using lateral cephalometric xray	up to 6 months
change in the Anterior facial height	measuring the change in the vertical distance between Nasion and Menton, using lateral cephalometric x-ray.	up to 6 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Hanan Ismail, PHD, Alexandria University; Principal Investigator: Tasneem Y Hammad, BDS, Alexandria University; Study Chair: Wessam Marzouk, PHD, Alexandria University; Study Chair: Hassan Moussa, PHD, Alexandria University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): April 20, 2021
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (ACTUAL): May 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Open Bite
• Other Study ID Numbers: Extrusionarchadults

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No