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Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch

Primary Purpose

Anterior Openbite Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
extrusion of the anterior teeth
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Openbite Malocclusion

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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:

  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.

Sites / Locations

  • Faculty of dentistry, Mansoura University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

open bite with extrusion arch

Arm Description

single arm study, measures will be recorded before and after

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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.
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.
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.
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).

Full Information

First Posted
July 24, 2022
Last Updated
March 13, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05492864
Brief Title
Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch
Official Title
Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Openbite Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open bite with extrusion arch
Arm Type
Experimental
Arm Description
single arm study, measures will be recorded before and after
Intervention Type
Procedure
Intervention Name(s)
extrusion of the anterior teeth
Intervention Description
sectional leveling and alignment of the teeth, then using of the extrusion arch as an overlay wire to treat the open bite
Primary Outcome Measure Information:
Title
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)
Description
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 Outcome Measure Information:
Title
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)
Description
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
Title
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)
Description
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
Title
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)
Description
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
Title
Skeletal, dental and soft tissues changes . Measurements will be done on pretreatment and posttreatment lateral cephalometric radiographs in degree (°)
Description
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
Title
Skeletal, dental and soft tissues changes . Measurements will be done on pretreatment and posttreatment lateral cephalometric radiographs in millimeters (mm)
Description
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
Title
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).
Description
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
Title
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)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Patients with skeletal open bite. Posterior cross bite. Trauma to the maxillary incisor. Patients in need to extraction due to sever crowding.
Facility Information:
Facility Name
Faculty of dentistry, Mansoura University
City
Mansoura
State/Province
El Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch

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