Anterior OpenbiteNCT04901221
The Use of Statically Determinate Force System in Closure of Anterior Open Bite in Adults.
A study testing Extrusion arch in people with Anterior Openbite, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 30 years
- Conditions the study is for
- Anterior Openbite
- What is being tested?
- Extrusion arch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients with anterior open bites more than 1 mm, permanent dentition except for the third molars which were extracted if erupted
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Anterior Openbite
- Being tested
- Extrusion arch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extrusion archDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Extrusion arch | Experimental | Hand made stainless steel extrusion arch wire (0.016x0.22") Receives: Device: Extrusion arch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: up to 6 months
Secondary outcomes (3)
change in the SN' to Mandibular plane angle
measuring the change in the angle between SN' to Mandibular plane angle, using lateral cephalometric xray
Measured: up to 6 months
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
Measured: up to 6 months
change in the Anterior facial height
measuring the change in the vertical distance between Nasion and Menton, using lateral cephalometric x-ray.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Apr 2019
- Primary completion20 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior OpenbiteStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasnim Yousry, Alexandria University
- Investigators
- Tasneem Y Hammad, BDS, Principal investigator, Alexandria UniversityHanan Ismail, PHD, Study director, Alexandria UniversityWessam Marzouk, PHD, Study chair, Alexandria UniversityHassan Moussa, PHD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901221
- Sponsor's protocol ID
- Extrusionarchadults
- Status last verified
- Jul 2022
- First submitted
- 20 May 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04901221
- Acronym / sponsor ID
- Extrusionarchadults
- Conditions
- Anterior Openbite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extrusion arch | Experimental | Device: Extrusion archHand made stainless steel extrusion arch wire (0.016x0.22") |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adult patients with anterior open bites more than 1 mm, permanent dentition except for the third molars which were extracted if erupted
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extrusion archone 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 | Device | Extrusion arch |
Primary outcome
angular and vertical linear effects on incisors
Time frame: up to 6 months
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
Time frame: up to 6 months
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.
3 secondary outcomes
change in the SN' to Mandibular plane angle
Time frame: up to 6 months
change in the palatal to Mandibular plane angle
Time frame: up to 6 months
change in the Anterior facial height
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
Related trials for Anterior Openbite
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Single Palatal Temporary Anchorage Device for Anterior Open Bite
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Treatment Effects of Vertical Holding Appliance in Comparison to Zachrisson Transpalatal Arch on Anterior Open Bite Correction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tasneem Y Hammad, BDS principal investigator
Alexandria University
Hanan Ismail, PHD study director
Alexandria University
Wessam Marzouk, PHD study chair
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extrusion arch in people with Anterior Openbite, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
angular and vertical linear effects on incisors (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.