NCT04901221

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

2.1 years

First QC Date

May 20, 2021

Last Update Submit

July 14, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • change in the SN' to Mandibular plane angle

    up to 6 months

  • change in the palatal to Mandibular plane angle

    up to 6 months

  • change in the Anterior facial height

    up to 6 months

Study Arms (1)

Extrusion arch

EXPERIMENTAL

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

Device: Extrusion arch

Interventions

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

Extrusion arch

Eligibility Criteria

Age17 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria faculty of Dentistry

Alexandria, 21527, Egypt

Location

Study Officials

  • Tasneem Y Hammad, BDS

    Alexandria University

    PRINCIPAL INVESTIGATOR
  • Hanan Ismail, PHD

    Alexandria University

    STUDY DIRECTOR
  • Wessam Marzouk, PHD

    Alexandria University

    STUDY CHAIR
  • Hassan Moussa, PHD

    Alexandria University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator of orthodontics

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

April 1, 2019

Primary Completion

April 20, 2021

Study Completion

May 1, 2021

Last Updated

July 15, 2022

Record last verified: 2022-07

Locations