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

Anterior Openbite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901221
• Other study ID #: Extrusionarchadults
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: July 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 1, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anterior Openbite
• Open Bite

Intervention

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

Locations

Country	Name	City	State
Egypt	Alexandria faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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