Anterior Open Bite MalocclusionNCT05599074
Stability of Anterior Open Bite Treatment Using Extrusion Arches
A study testing extrusion arch in people with Anterior Open Bite Malocclusion, run by Alexandria University at 1 site in Egypt.
Trial summary
This study investigated treatment effects and stability of anterior open bite cases using extrusion arches Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Open Bite Malocclusion
- 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 2022
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult patients above 18 years anterior open bite 2-6 mm full permanent dentition incisors requiring extrusion
Who cannot join
- increased incisal show at rest
- gum show at smiling cleft patients patient with tempro-mandibular joint problems FMA angle above 45
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Anterior Open Bite Malocclusion
- Being tested
- extrusion arch
- Keywords
- extrusion arches, anterior open bite, stability, extrusion, intrusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extrusion archDevice
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
| Study group | Role | What they receive |
|---|---|---|
| AOB adults | Experimental | adult patients over 18 years having an anterior open bite of more than 2 mm, requiring incisors extrusion Receives: Device: extrusion arch |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNA angle
The anteroposterior position of maxillary base to the anterior cranial base.
Measured: 18 months
SNB angle
The anteroposterior position of mandibular base to the anterior cranial base.
Measured: 18 months
ANB angle
The anteroposterior position of maxillary base to the mandibular base.
Measured: 18 months
SN-MP angle
Mandibular plane angle, the angle between the mandibular plane (Go-Me) and anterior cranial base plane (SN).
Measured: 18 months
PP-MP angle
The angle between palatal plane (ANS-PNS) and mandibular plane.
Measured: 18 months
AFH
Anterior facial height, the measurement between Nasion (N) and Menton (Me).
Measured: 18 months
interincisal angle
- The inner angle between the long axis of the maxillary central incisor and long axis of mandibular central incisor.
Measured: 18 months
L1 to MP in mm
- The perpendicular distance between the most anterior mandibular central incisor and mandibular plane.
Measured: 18 months
L1 to MP angle
The angle between long axis of the most anterior central incisor and the mandibular plane.
Measured: 18 months
overbite
Vertical distances between the incisal edges of the maxillary and mandibular central incisors, perpendicular to N-Me.
Measured: 18 months
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).
Measured: 18 months
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.
Measured: 18 months
U6 to PP in mm
-The perpendicular distance between the mesial cusp tip of the upper first maxillary molar and the palatal plane.
Measured: 18 months
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.
Measured: 18 months
L6 to MP in mm
The perpendicular distance between mesial cusp tip of the lower first molar and the mandibular plane.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Apr 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Open Bite MalocclusionStudies 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
- Model description
- Before and after design
- 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 hammad, BDS, Principal investigator, Alexandria Universityhanan ismail, PHD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599074
- Sponsor's protocol ID
- AOBtreatmentinadults
- Status last verified
- Nov 2022
- First submitted
- 18 Oct 2022
- Last updated
- 9 Nov 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Results and Stability of Anterior Open Bite Cases Treated Using Extrusion Arches in Adults
- ClinicalTrials.gov ID
- NCT05599074
- Acronym / sponsor ID
- AOBtreatmentinadults
- Conditions
- Anterior Open Bite Malocclusion
- Keywords
- extrusion arches, anterior open bite, stability, extrusion, intrusion
- 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
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 31 Oct 2022 (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.
This study investigated treatment effects and stability of anterior open bite cases using extrusion arches
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after design
| Arm | Type | Receives |
|---|---|---|
| AOB adults | Experimental | Device: extrusion archadult patients over 18 years having an anterior open bite of more than 2 mm, requiring incisors extrusion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult patients above 18 years anterior open bite 2-6 mm full permanent dentition incisors requiring extrusion
Key exclusion criteria (2 listed)
- increased incisal show at rest
- gum show at smiling cleft patients patient with tempro-mandibular joint problems FMA angle above 45
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 archA 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 | Device | AOB adults |
Primary outcome
SNA angle
Time frame: 18 months
The anteroposterior position of maxillary base to the anterior cranial base.
SNB angle
Time frame: 18 months
The anteroposterior position of mandibular base to the anterior cranial base.
ANB angle
Time frame: 18 months
The anteroposterior position of maxillary base to the mandibular base.
SN-MP angle
Time frame: 18 months
Mandibular plane angle, the angle between the mandibular plane (Go-Me) and anterior cranial base plane (SN).
PP-MP angle
Time frame: 18 months
The angle between palatal plane (ANS-PNS) and mandibular plane.
AFH
Time frame: 18 months
Anterior facial height, the measurement between Nasion (N) and Menton (Me).
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.
L1 to MP in mm
Time frame: 18 months
- The perpendicular distance between the most anterior mandibular central incisor and mandibular plane.
L1 to MP angle
Time frame: 18 months
The angle between long axis of the most anterior central incisor and the mandibular plane.
overbite
Time frame: 18 months
Vertical distances between the incisal edges of the maxillary and mandibular central incisors, perpendicular to N-Me.
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).
u6 to pp angle
Time frame: 18 months
-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
Time frame: 18 months
-The perpendicular distance between the mesial cusp tip of the upper first maxillary molar and the palatal plane.
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.
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.
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 9 Nov 2022.
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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 hammad, BDS principal investigator
Alexandria University
hanan ismail, PHD study director
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 Open Bite Malocclusion, 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 2 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 9 Nov 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?
SNA angle (time frame: 18 months). The study lists 15 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 9 Nov 2022.