Anterior Openbite MalocclusionNCT05492864
Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch
A study testing extrusion of the anterior teeth in people with Anterior Openbite Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will aim to evaluate the effect of skeletally anchored extrusion arch on the dentofacial structures in patients with anterior open bite (AOB). Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Anterior Openbite Malocclusion
- What is being tested?
- extrusion of the anterior teeth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 19 May 2021to 19 Dec 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 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with a class I or a mild class II dental relationship.
- All permanent teeth are erupted except the third molars.
- Mild to moderate open bite is present.
- Normal or minimally increased facial height.
- Low lip line.
- No or Mild crowding.
Who cannot join
- Patients with skeletal open bite.
- Posterior cross bite.
- Trauma to the maxillary incisor.
- Patients in need to extraction due to sever crowding.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
This study will aim to evaluate the effect of skeletally anchored extrusion arch on the dentofacial structures in patients with anterior open bite (AOB).
Read the detailed description
This study will be a prospective clinical study. All the patients will be treated with 0.022 inch slot Roth metal brackets. Orthodontic bands will be cemented to the maxillary first molars. Both maxillary and mandibular teeth, will be sectionally leveled and aligned with superelastic Ni-Ti archwires.
A buccal stiff sectional wire from the first molar to the canine will be added for anchorage reinforcement. Extrusion will be done by inverting a 0.017 × 0.025-inch Connecticut intrusion archwire and inserting it in the molar auxiliary tubes upside-down and miniscrew will be tied to the molar bands to act as additional indirect anchorage.
- Conditions
- Anterior Openbite Malocclusion
- Being tested
- extrusion of the anterior teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extrusion of the anterior teethProcedure or surgery
sectional leveling and alignment of the teeth, then using of the extrusion arch as an overlay wire to treat the open bite
| Study group | Role | What they receive |
|---|---|---|
| open bite with extrusion arch | Experimental | single arm study, measures will be recorded before and after Receives: Procedure: extrusion of the anterior teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the overbite and overjet "Amount of open bite closure". -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm)
Amount of open bite closure measurement will help to know the effect of skeletally anchored extrusion arch on the treatment of anterior open bite
- Mean change will be measured on pretreatment and posttreatment digital study models by measuring the vertical linear distance between the mesiodistal midpoint of the incisal edge of the uppermost vertically erupted upper central incisors and a horizontal plane projected on the lower central incisor(overbite) in millimeters(mm).
- Also mean change will be measured on pretreatment and posttreatment digital study models by measuring the horizontal linear distance between the incisal edge of the most protruded upper central incisor and a frontal plane projected on the lower central incisor (overjet) in millimeters (mm).
Measured: one year
Secondary outcomes (7)
Mean change in the Antero-posterior position of permanent maxillary first molar. -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm)
- Mean change in the Antero-posterior position of permanent maxillary first molar will help to know the effect of skeletally anchored extrusion arch on the posterior teeth.
- Change will be measured on pretreatment and posttreatment digital study models by measuring the linear distance between the mesial surface of the upper first molar and a line joining the medial end of the two third rugae, the mean between the right and left sides will be used in millimeters(mm)
- Also will be measured on pretreatment and posttreatment digital study models by measuring the horizontal linear distance between the mesiobuccal cusp of upper first molar and mesiobuccal groove of lower first molar, the mean between the right and left sides will be used in millimeters (mm).
Measured: one year
Changes that occur in the dentoalveolar vertical development of the upper and lower anterior teeth. -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm)
- Changes that occur in the dentoalveolar vertical development of the upper and lower anterior teeth will help to know the effect of skeletally anchored extrusion arch on the vertical development of the anterior teeth.
- Change will be measured on pretreatment and posttreatment digital study models by measuring The perpendicular vertical distance from a point between the central incisors at the level of the alveolar process to the occlusal plane from the frontal view, the occlusal plane was determined by three points: mesiobuccal cusp tip of the right and left first permanent molars and cusp tip of the right first premolar in millimeters (mm).
- Also will be measured on pretreatment and posttreatment digital study models by measuring the vertical distance between the incisal edge and gingival margin of the central incisor along its labial surface, the mean between the right and left sides will be used in millimeters(mm).
Measured: one year
Changes that will occur in the upper and lower arch length, perimeter and intermolar width. -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm)
- This outcome will help to know the effect of skeletally anchored extrusion arch on the upper and lower arch length, perimeter and intermolar width.
- Change will be measured on pretreatment and posttreatment digital study models by measuring the perpendicular distance between a line connecting the mesial aspects of the permanent first molars and the contact point between the central incisors (arch length) in millimeters(mm), measuring the sum of four segments: from the mesial surface of the permanent first molar to the mesial contact point of the canine and then to the contact point of the central incisors, measured on the right and left sides (arch perimeter)in millimeters (mm) and measuring the linear distance between right and left first permanent molar (intermolar width) in millimeters (mm).
Measured: one year
Skeletal, dental and soft tissues changes . Measurements will be done on pretreatment and posttreatment lateral cephalometric radiographs in degree (°)
- This outcome will help to know the effect of skeletally anchored extrusion arch on the dentofacial structures in patients with anterior open bite.
- Measurements will be done on pretreatment and posttreatment lateral cephalometric radiographs:
- SNA(°)/SNB(°)/ANB(°) will show changes in skeletal antero-posterior relationship between maxilla and mandible.
- MP(Me-GO)-SN(°)/Palato-mandibular plane(°)/FH-OP(°)/FH-PP(°)/Gonial angle(°) will show skeletal vertical changes.
- Occlusal plane- SN (°) will show dental vertical changes.
- L1-MP(°)(IMPA)/U1-PP(°)/Interincisal angle(°) will show dental incisor inclination.
- Nasolabial angle(°) will show Soft tissues changes.
Measured: one year
Skeletal, dental and soft tissues changes . Measurements will be done on pretreatment and posttreatment lateral cephalometric radiographs in millimeters (mm)
- This outcome will help to know the effect of skeletally anchored extrusion arch on the dentofacial structures in patients with anterior open bite.
- Measurements will be done on pretreatment and posttreatment lateral cephalometric radiographs:
- Witts(mm) will show changes in skeletal antero-posterior relationship between maxilla and mandible.
- ALFH(ANS-Me)(mm)/A-ANS(mm)/N-Me(mm)/Co-GO(mm) will show skeletal vertical changes.
- U6-PP(mm)/U1-pp(mm)/L6-MP(mm)/L1-MP(mm) will show dental vertical changes.
- U1-Eplane(mm)/L1-Eplane(mm) will show Soft tissues changes.
Measured: one year
Change in the smile of the patients through measuring mean change in the lenght of the upper lip, amount of incisors and gum exposure. Measurements will be done on pretreatment and posttreatment photographs in millimeters (mm).
This outcome will help to know the effect of extrusion of the anterior teeth on the smile of the patients.
Pretreatment and posttreatment extraoral photographs will be taken, including a close-up photograph with a ruler while the patient is smiling.
Measured: one year
Stability of the treatment after 1, 2 and 3year(s) through measuring mean change in the overbite. Measurements will be done on digital study models in millimeters(mm)
This outcome will help to know the stability of the technique of using of skeletally anchored extrusion arch in the treatment of anterior open bite patients.
-stability will be measured on posttreatment after 1, 2 and 3 years posttreatment digital study models by measuring the vertical linear distance between the mesiodistal midpoint of the incisal edge of the uppermost vertically erupted upper central incisors and a horizontal plane projected on the lower central incisor(overbite) in millimeters(mm).
Measured: Two year, three and four year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start19 May 2021
- Primary completion19 Sep 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Openbite MalocclusionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492864
- Sponsor's protocol ID
- 9148620
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch
- ClinicalTrials.gov ID
- NCT05492864
- Acronym / sponsor ID
- 9148620
- Conditions
- Anterior Openbite Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 9 Aug 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 will aim to evaluate the effect of skeletally anchored extrusion arch on the dentofacial structures in patients with anterior open bite (AOB).
Detailed description
This study will be a prospective clinical study. All the patients will be treated with 0.022 inch slot Roth metal brackets. Orthodontic bands will be cemented to the maxillary first molars. Both maxillary and mandibular teeth, will be sectionally leveled and aligned with superelastic Ni-Ti archwires.
A buccal stiff sectional wire from the first molar to the canine will be added for anchorage reinforcement. Extrusion will be done by inverting a 0.017 × 0.025-inch Connecticut intrusion archwire and inserting it in the molar auxiliary tubes upside-down and miniscrew will be tied to the molar bands to act as additional indirect anchorage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open bite with extrusion arch | Experimental | Procedure: extrusion of the anterior teethsingle arm study, measures will be recorded before and after |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients with a class I or a mild class II dental relationship.
- All permanent teeth are erupted except the third molars.
- Mild to moderate open bite is present.
- Normal or minimally increased facial height.
- Low lip line.
Key exclusion criteria (4 listed)
- Patients with skeletal open bite.
- Posterior cross bite.
- Trauma to the maxillary incisor.
- Patients in need to extraction due to sever crowding.
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 of the anterior teethsectional leveling and alignment of the teeth, then using of the extrusion arch as an overlay wire to treat the open bite | Procedure or surgery | open bite with extrusion arch |
Primary outcome
Mean change in the overbite and overjet "Amount of open bite closure". -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm)
Time frame: one year
Amount of open bite closure measurement will help to know the effect of skeletally anchored extrusion arch on the treatment of anterior open bite * Mean change will be measured on pretreatment and posttreatment digital study models by measuring the vertical linear distance between the mesiodistal midpoint of the incisal edge of the uppermost vertically erupted upper central incisors and a horizontal plane projected on the lower central incisor(overbite) in millimeters(mm). * Also mean change will be measured on pretreatment and posttreatment digital study models by measuring the horizontal linear distance between the incisal edge of the most protruded upper central incisor and a frontal plane projected on the lower central incisor (overjet) in millimeters (mm).
7 secondary outcomes
Mean change in the Antero-posterior position of permanent maxillary first molar. -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm)
Time frame: one year
Changes that occur in the dentoalveolar vertical development of the upper and lower anterior teeth. -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm)
Time frame: one year
Changes that will occur in the upper and lower arch length, perimeter and intermolar width. -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm)
Time frame: one year
Skeletal, dental and soft tissues changes . Measurements will be done on pretreatment and posttreatment lateral cephalometric radiographs in degree (°)
Time frame: one year
Skeletal, dental and soft tissues changes . Measurements will be done on pretreatment and posttreatment lateral cephalometric radiographs in millimeters (mm)
Time frame: one year
Change in the smile of the patients through measuring mean change in the lenght of the upper lip, amount of incisors and gum exposure. Measurements will be done on pretreatment and posttreatment photographs in millimeters (mm).
Time frame: one year
Stability of the treatment after 1, 2 and 3year(s) through measuring mean change in the overbite. Measurements will be done on digital study models in millimeters(mm)
Time frame: Two year, three and four year.
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 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Anterior Openbite Malocclusion
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Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite
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Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite
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Active, not recruiting
Anterior Open Bite Closure by Clear Aligners Versus Fixed Appliances in Adult Patients With Skeletal Open Bite: A Randomized Clinical Trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of the anterior teeth in people with Anterior Openbite Malocclusion, run by Mansoura 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 6 inclusion and 4 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 Mar 2023. 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?
Mean change in the overbite and overjet "Amount of open bite closure". -Measurements will be done on pretreatment and posttreatment digital study models in millimeters(mm) (time frame: one year). 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 Mar 2023.