The Use of Statically Determinate Force System in Closure of Anterior Open Bite in Adults.
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
1 other identifier
interventional
23
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedFirst Submitted
Initial submission to the registry
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedJuly 15, 2022
July 1, 2022
2.1 years
May 20, 2021
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
EXPERIMENTALHand made stainless steel extrusion arch wire (0.016x0.22")
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
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Tasneem Y Hammad, BDS
Alexandria University
- STUDY DIRECTOR
Hanan Ismail, PHD
Alexandria University
- STUDY CHAIR
Wessam Marzouk, PHD
Alexandria University
- STUDY CHAIR
Hassan Moussa, PHD
Alexandria University
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