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CompletedNCT04901221Updated Jul 15, 2022

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

An interventional study of Extrusion arch in Anterior Openbite, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 17 Years to 30 Years. Per ClinicalTrials.gov, last updated 2022-07-15.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Apr 2019, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
17 Years to 30 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anterior Openbite
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 586 studies on the registry; 127 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Extrusion arch

    Hand made stainless steel extrusion arch wire (0.016x0.22")

    Device: Extrusion arch

Interventions

  • DeviceExtrusion 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 6 months

  2. 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.

    Time frame: up to 6 months

Secondary outcomes

  1. change in the SN' to Mandibular plane angle

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

    Time frame: up to 6 months

  2. 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

    Time frame: up to 6 months

  3. change in the Anterior facial height

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

    Time frame: up to 6 months

07

Study locations

1 site
  • Alexandria faculty of Dentistry
    Alexandria, 21527, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04901221
Responsible party
Tasnim Yousry (Demonstrator of orthodontics, Alexandria University) — Principal investigator
First posted
May 25, 2021
Start date
Apr 1, 2019
Primary completion
Apr 20, 2021
Completion
May 1, 2021
Last update
Jul 15, 2022

Study contacts

Tasneem Y Hammad, BDS
principal investigator · Alexandria University
Hanan Ismail, PHD
study director · Alexandria University
Wessam Marzouk, PHD
study chair · Alexandria University
Hassan Moussa, PHD
study chair · Alexandria University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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