Back to resultsThe Use of Statically Determinate Force System in Closure of Anterior Open Bite in Adults.
Primary Purpose
Anterior Openbite
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Extrusion arch
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Openbite
Eligibility Criteria
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.
Sites / Locations
- Alexandria faculty of Dentistry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Extrusion arch
Arm Description
Hand made stainless steel extrusion arch wire (0.016x0.22")
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
change in the SN' to Mandibular plane angle
measuring the change in the angle between SN' to Mandibular plane angle, using lateral cephalometric xray
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
change in the Anterior facial height
measuring the change in the vertical distance between Nasion and Menton, using lateral cephalometric x-ray.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04901221
Brief Title
The Use of Statically Determinate Force System in Closure of Anterior Open Bite in Adults.
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Openbite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extrusion arch
Arm Type
Experimental
Arm Description
Hand made stainless steel extrusion arch wire (0.016x0.22")
Intervention Type
Device
Intervention Name(s)
Extrusion arch
Intervention Description
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 Outcome Measure Information:
Title
angular and vertical linear effects on incisors
Description
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
Title
angular and vertical linear effects on first molars
Description
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 Outcome Measure Information:
Title
change in the SN' to Mandibular plane angle
Description
measuring the change in the angle between SN' to Mandibular plane angle, using lateral cephalometric xray
Time Frame
up to 6 months
Title
change in the palatal to Mandibular plane angle
Description
measuring the change in the angle between the palatal to Mandibular plane angle, using lateral cephalometric xray
Time Frame
up to 6 months
Title
change in the Anterior facial height
Description
measuring the change in the vertical distance between Nasion and Menton, using lateral cephalometric x-ray.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tasneem Y Hammad, BDS
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanan Ismail, PHD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wessam Marzouk, PHD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hassan Moussa, PHD
Organizational Affiliation
Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Alexandria faculty of Dentistry
City
Alexandria
ZIP/Postal Code
21527
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
The Use of Statically Determinate Force System in Closure of Anterior Open Bite in Adults.
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