- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05599074
Stability of Anterior Open Bite Treatment Using Extrusion Arches
November 5, 2022 updated by: Tasnim Yousry, Alexandria University
Treatment Results and Stability of Anterior Open Bite Cases Treated Using Extrusion Arches in Adults
This study investigated treatment effects and stability of anterior open bite cases using extrusion arches
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandria, Egypt, 21589
- Alexandria Faculty of Dentistry
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: AOB adults
adult patients over 18 years having an anterior open bite of more than 2 mm, requiring incisors extrusion
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SNA angle
Time Frame: 18 months
|
The anteroposterior position of maxillary base to the anterior cranial base.
|
18 months
|
|
SNB angle
Time Frame: 18 months
|
The anteroposterior position of mandibular base to the anterior cranial base.
|
18 months
|
|
ANB angle
Time Frame: 18 months
|
The anteroposterior position of maxillary base to the mandibular base.
|
18 months
|
|
SN-MP angle
Time Frame: 18 months
|
Mandibular plane angle, the angle between the mandibular plane (Go-Me) and anterior cranial base plane (SN).
|
18 months
|
|
PP-MP angle
Time Frame: 18 months
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The angle between palatal plane (ANS-PNS) and mandibular plane.
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18 months
|
|
AFH
Time Frame: 18 months
|
Anterior facial height, the measurement between Nasion (N) and Menton (Me).
|
18 months
|
|
interincisal angle
Time Frame: 18 months
|
- The inner angle between the long axis of the maxillary central incisor and long axis of mandibular central incisor.
|
18 months
|
|
L1 to MP in mm
Time Frame: 18 months
|
- The perpendicular distance between the most anterior mandibular central incisor and mandibular plane.
|
18 months
|
|
L1 to MP angle
Time Frame: 18 months
|
The angle between long axis of the most anterior central incisor and the mandibular plane.
|
18 months
|
|
overbite
Time Frame: 18 months
|
Vertical distances between the incisal edges of the maxillary and mandibular central incisors, perpendicular to N-Me.
|
18 months
|
|
U1 to PP angular and linear measurements
Time Frame: 18 months
|
-The angle and perpendicular distance between long axis of the most anterior upper central incisor and the Palatal plane (ANS-PNS).
|
18 months
|
|
u6 to pp angle
Time Frame: 18 months
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-The angle between the axis between mesial cusp tip and mesiobuccal root apex of the upper first molar and the palatal plane.
|
18 months
|
|
U6 to PP in mm
Time Frame: 18 months
|
-The perpendicular distance between the mesial cusp tip of the upper first maxillary molar and the palatal plane.
|
18 months
|
|
L6 to MP angle
Time Frame: 18 months
|
The angle between the axis between mesial cusp tip and mesial root apex of the lower first molar and the mandibular plane.
|
18 months
|
|
L6 to MP in mm
Time Frame: 18 months
|
The perpendicular distance between mesial cusp tip of the lower first molar and the mandibular plane.
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: tasneem hammad, BDS, Alexandria University
- Study Director: Hanan Ismail, PHD, Alexandria University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2019
Primary Completion (ACTUAL)
May 1, 2022
Study Completion (ACTUAL)
May 1, 2022
Study Registration Dates
First Submitted
October 18, 2022
First Submitted That Met QC Criteria
October 25, 2022
First Posted (ACTUAL)
October 31, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 5, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOBtreatmentinadults
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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