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OpenTrials
Completed

NCT Number: NCT04901221

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

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.

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Key information

Conditions

Anterior Openbite

Age range

17 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria faculty of Dentistry

Alexandria, 21527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extrusion arch

Device

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

Primary outcomes

  1. angular and vertical linear effects on incisors

    Time frame: up to 6 months

    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

  2. angular and vertical linear effects on first molars

    Time frame: up to 6 months

    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.

Secondary outcomes

  1. change in the SN' to Mandibular plane angle

    Time frame: up to 6 months

    measuring the change in the angle between SN' to Mandibular plane angle, using lateral cephalometric xray

  2. change in the palatal to Mandibular plane angle

    Time frame: up to 6 months

    measuring the change in the angle between the palatal to Mandibular plane angle, using lateral cephalometric xray

  3. change in the Anterior facial height

    Time frame: up to 6 months

    measuring the change in the vertical distance between Nasion and Menton, using lateral cephalometric x-ray.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 25, 2021
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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