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Stability of Anterior Open Bite Treatment Using Extrusion Arches

Primary Purpose

Anterior Open Bite Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
extrusion arch
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Open Bite Malocclusion focused on measuring extrusion arches, anterior open bite, stability, extrusion, intrusion

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: adult patients above 18 years anterior open bite 2-6 mm full permanent dentition incisors requiring extrusion Exclusion Criteria: increased incisal show at rest gum show at smiling cleft patients patient with tempro-mandibular joint problems FMA angle above 45

Sites / Locations

  • Alexandria faculty of Dentistry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AOB adults

Arm Description

adult patients over 18 years having an anterior open bite of more than 2 mm, requiring incisors extrusion

Outcomes

Primary Outcome Measures

SNA angle
The anteroposterior position of maxillary base to the anterior cranial base.
SNB angle
The anteroposterior position of mandibular base to the anterior cranial base.
ANB angle
The anteroposterior position of maxillary base to the mandibular base.
SN-MP angle
Mandibular plane angle, the angle between the mandibular plane (Go-Me) and anterior cranial base plane (SN).
PP-MP angle
The angle between palatal plane (ANS-PNS) and mandibular plane.
AFH
Anterior facial height, the measurement between Nasion (N) and Menton (Me).
interincisal angle
- The inner angle between the long axis of the maxillary central incisor and long axis of mandibular central incisor.
L1 to MP in mm
- The perpendicular distance between the most anterior mandibular central incisor and mandibular plane.
L1 to MP angle
The angle between long axis of the most anterior central incisor and the mandibular plane.
overbite
Vertical distances between the incisal edges of the maxillary and mandibular central incisors, perpendicular to N-Me.
U1 to PP angular and linear measurements
-The angle and perpendicular distance between long axis of the most anterior upper central incisor and the Palatal plane (ANS-PNS).
u6 to pp angle
-The angle between the axis between mesial cusp tip and mesiobuccal root apex of the upper first molar and the palatal plane.
U6 to PP in mm
-The perpendicular distance between the mesial cusp tip of the upper first maxillary molar and the palatal plane.
L6 to MP angle
The angle between the axis between mesial cusp tip and mesial root apex of the lower first molar and the mandibular plane.
L6 to MP in mm
The perpendicular distance between mesial cusp tip of the lower first molar and the mandibular plane.

Secondary Outcome Measures

Full Information

First Posted
October 18, 2022
Last Updated
November 5, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05599074
Brief Title
Stability of Anterior Open Bite Treatment Using Extrusion Arches
Official Title
Treatment Results and Stability of Anterior Open Bite Cases Treated Using Extrusion Arches in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (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
This study investigated treatment effects and stability of anterior open bite cases using extrusion arches

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Open Bite Malocclusion
Keywords
extrusion arches, anterior open bite, stability, extrusion, intrusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after design
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AOB adults
Arm Type
Experimental
Arm Description
adult patients over 18 years having an anterior open bite of more than 2 mm, requiring incisors extrusion
Intervention Type
Device
Intervention Name(s)
extrusion arch
Intervention Description
A stainless steel pre-formed arch wire custom made by placing V-bends 3-5 mm mesial to the molar tubes, placed into the auxiliary molar tubes after leveling phase and tied over the main arch wire distal to the lateral incisors
Primary Outcome Measure Information:
Title
SNA angle
Description
The anteroposterior position of maxillary base to the anterior cranial base.
Time Frame
18 months
Title
SNB angle
Description
The anteroposterior position of mandibular base to the anterior cranial base.
Time Frame
18 months
Title
ANB angle
Description
The anteroposterior position of maxillary base to the mandibular base.
Time Frame
18 months
Title
SN-MP angle
Description
Mandibular plane angle, the angle between the mandibular plane (Go-Me) and anterior cranial base plane (SN).
Time Frame
18 months
Title
PP-MP angle
Description
The angle between palatal plane (ANS-PNS) and mandibular plane.
Time Frame
18 months
Title
AFH
Description
Anterior facial height, the measurement between Nasion (N) and Menton (Me).
Time Frame
18 months
Title
interincisal angle
Description
- The inner angle between the long axis of the maxillary central incisor and long axis of mandibular central incisor.
Time Frame
18 months
Title
L1 to MP in mm
Description
- The perpendicular distance between the most anterior mandibular central incisor and mandibular plane.
Time Frame
18 months
Title
L1 to MP angle
Description
The angle between long axis of the most anterior central incisor and the mandibular plane.
Time Frame
18 months
Title
overbite
Description
Vertical distances between the incisal edges of the maxillary and mandibular central incisors, perpendicular to N-Me.
Time Frame
18 months
Title
U1 to PP angular and linear measurements
Description
-The angle and perpendicular distance between long axis of the most anterior upper central incisor and the Palatal plane (ANS-PNS).
Time Frame
18 months
Title
u6 to pp angle
Description
-The angle between the axis between mesial cusp tip and mesiobuccal root apex of the upper first molar and the palatal plane.
Time Frame
18 months
Title
U6 to PP in mm
Description
-The perpendicular distance between the mesial cusp tip of the upper first maxillary molar and the palatal plane.
Time Frame
18 months
Title
L6 to MP angle
Description
The angle between the axis between mesial cusp tip and mesial root apex of the lower first molar and the mandibular plane.
Time Frame
18 months
Title
L6 to MP in mm
Description
The perpendicular distance between mesial cusp tip of the lower first molar and the mandibular plane.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult patients above 18 years anterior open bite 2-6 mm full permanent dentition incisors requiring extrusion Exclusion Criteria: increased incisal show at rest gum show at smiling cleft patients patient with tempro-mandibular joint problems FMA angle above 45
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tasneem 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
Facility Information:
Facility Name
Alexandria faculty of Dentistry
City
Alexandria
ZIP/Postal Code
21589
Country
Egypt

12. IPD Sharing Statement

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Stability of Anterior Open Bite Treatment Using Extrusion Arches

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