ClinicalTrials.gg
CompletedNCT05492864Updated Mar 15, 2023

Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch

An interventional study of extrusion of the anterior teeth in Anterior Openbite Malocclusion, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 12 Years to 15 Years. Per ClinicalTrials.gov, last updated 2023-03-15.

Primary conditionOpen BiteRegistry: MalocclusionReclassifiedWhy we changed it
Registry
Malocclusion — the first condition term the registry derived for this study.
ClinicalTrials.gg
Open Bite
Why
  1. The study's listed conditions name Open Bite, a narrower term within Malocclusion.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
12 Years to 15 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anterior Openbite Malocclusion

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03

In context

Open Bite Reclassified

34 studies on the registry are indexed under Open Bite; 8 are open to participants now.

This study's enrollment of 20 is below the median of 30 across 28 interventional studies indexed under Open Bite.

Browse Open Bite studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Open Bite, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Malocclusion. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
12 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with a class I or a mild class II dental relationship.
  2. All permanent teeth are erupted except the third molars.
  3. Mild to moderate open bite is present.
  4. Normal or minimally increased facial height.
  5. Low lip line.
  6. No or Mild crowding.

Exclusion criteria

Exclusion Criteria:

  1. Patients with skeletal open bite.
  2. Posterior cross bite.
  3. Trauma to the maxillary incisor.
  4. Patients in need to extraction due to sever crowding.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    open bite with extrusion arch

    single arm study, measures will be recorded before and after

    Procedure: extrusion of the anterior teeth

Interventions

  • Procedureextrusion of the anterior teeth

    sectional leveling and alignment of the teeth, then using of the extrusion arch as an overlay wire to treat the open bite

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: one year

Secondary outcomes

  1. 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).

    Time frame: one year

  2. 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).

    Time frame: one year

  3. 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).

    Time frame: one year

  4. 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.

    Time frame: one year

  5. 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.

    Time frame: one year

  6. 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.

    Time frame: one year

  7. 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).

    Time frame: Two year, three and four year.

07

Study locations

1 site
  • Faculty of dentistry, Mansoura University
    Mansoura, El Dakahlia 35511, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2021 to primary completion in Sep 2022, 16 months.

Of 24 interventional studies with no phase under Open Bite, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 16 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2022
First posted
Aug 9, 2022
StartActual
May 19, 2021
Primary completionActual
Sep 19, 2022
CompletionActual
Dec 19, 2022
Last update
Mar 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05492864
Responsible party
Sponsor
First posted
Aug 9, 2022
Start date
May 19, 2021
Primary completion
Sep 19, 2022
Completion
Dec 19, 2022
Last update
Mar 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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