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Maxillary Versus Bi-Maxillary Posterior Segments Intrusion Adult Subjects With Skeletal Open Bite

Primary Purpose

Dental Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Maxillary posterior dento-alveolar intrusion
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Malocclusion focused on measuring molar intrusion, open bite, mini-screws

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Skeletal open bite with a dental open bite ranging from 3-8 mm.
  • Adequate incisal show at rest and on smiling
  • Full set of posterior teeth from first premolar to second molar (with the exception of one tooth in one quadrant).

Exclusion Criteria:

  • Dental open bites without skeletal components
  • Previous orthodontic treatment
  • Medically compromised patients

Sites / Locations

  • Orthodontic Department, Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Maxillary posterior dento-alveolar intrusion

Bi-maxillary posterior dento-alveolar intrusion

Arm Description

Mini-screw supported maxillary posterior dento-alveolar intrusion

Mini-screw supported bi-maxillary posterior dento-alveolar intrusion

Outcomes

Primary Outcome Measures

Open bite closure clinically in millimeters using a digital caliper/ruler.
The amount of overbite gained as a result of posterior dento-alveolar intrusion
Maxillary posterior teeth intrusion radiographically in millimeters.
The distance travelled by maxillary premolars and molars of the right and left sides to a reference plane
Mandibular posterior teeth intrusion/extrusion radiographically in millimeters.
The distance travelled by mandibular premolars and molars of the right and left sides to a reference plane (mandibular plane)

Secondary Outcome Measures

Tipping of intruded teeth radiographically in degrees.
• Tipping is measured as the change in the angle between the long axis of the intruded teeth and the Frankfurt Horizontal plane as viewed sagitally (projected on the mid-sagittal plane).
Torque of intruded teeth radiographically in degrees.
• Torque change is measured as the change in the angle between the long axis of the intruded teeth and the mid-sagittal plane as viewed frontally (projected on the frontal plane).
Root resorption of intruded teeth in millimeters radiographically.
• The difference in the root lengths on the pre and post-intrusion CBCT's will be calculated. Root lengths will be measured from the buccal/mesiobuccal cusp tips to corresponding root apices for premolars and molars respectively.
Vertical skeletal measurements radiographically in millimeters or angles according to the measurement.
SN/MP: change in mandibular plane inclination relative to the cranial base. MMA: change in mandibular plane inclination relative to the maxillary plane. LAFH: change in lower anterior facial height.

Full Information

First Posted
January 14, 2021
Last Updated
March 25, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04713280
Brief Title
Maxillary Versus Bi-Maxillary Posterior Segments Intrusion Adult Subjects With Skeletal Open Bite
Official Title
Maxillary Versus Bi-Maxillary Posterior Segments Intrusion in Treatment of Adult Subjects With Skeletal Open Bite - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

Brief Summary
Compare between bi-maxillary (maxillary and mandibular) posterior dento-alveolar intrusion and maxillary posterior dento-alveolar intrusion as regards open bite closure.
Detailed Description
Now, maxillary posterior dento-alveolar intrusion has been validated as a conservative treatment modality for treatment of skeletal open bite in adult patients. However, it was proved that mandibular posterior teeth extrusion take place during the treatment which results in reduction in the amount of open. bite closure. Therefore, the aim of our study is to compare in a randomized clinical trial methodology between maxillary posterior dento-alveolar intrusion and combined maxillary and mandibular posterior dento-alveolar intrusion in terms of anterior open bite closure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion
Keywords
molar intrusion, open bite, mini-screws

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maxillary posterior dento-alveolar intrusion
Arm Type
Active Comparator
Arm Description
Mini-screw supported maxillary posterior dento-alveolar intrusion
Arm Title
Bi-maxillary posterior dento-alveolar intrusion
Arm Type
Experimental
Arm Description
Mini-screw supported bi-maxillary posterior dento-alveolar intrusion
Intervention Type
Procedure
Intervention Name(s)
Maxillary posterior dento-alveolar intrusion
Other Intervention Name(s)
Bi-maxillary posterior dento-alveolar intrusion
Intervention Description
Mini-screw supported maxillary or bi-maxillary posterior dento-alveolar intrusion
Primary Outcome Measure Information:
Title
Open bite closure clinically in millimeters using a digital caliper/ruler.
Description
The amount of overbite gained as a result of posterior dento-alveolar intrusion
Time Frame
6 months
Title
Maxillary posterior teeth intrusion radiographically in millimeters.
Description
The distance travelled by maxillary premolars and molars of the right and left sides to a reference plane
Time Frame
6 months
Title
Mandibular posterior teeth intrusion/extrusion radiographically in millimeters.
Description
The distance travelled by mandibular premolars and molars of the right and left sides to a reference plane (mandibular plane)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tipping of intruded teeth radiographically in degrees.
Description
• Tipping is measured as the change in the angle between the long axis of the intruded teeth and the Frankfurt Horizontal plane as viewed sagitally (projected on the mid-sagittal plane).
Time Frame
6 months
Title
Torque of intruded teeth radiographically in degrees.
Description
• Torque change is measured as the change in the angle between the long axis of the intruded teeth and the mid-sagittal plane as viewed frontally (projected on the frontal plane).
Time Frame
6 months
Title
Root resorption of intruded teeth in millimeters radiographically.
Description
• The difference in the root lengths on the pre and post-intrusion CBCT's will be calculated. Root lengths will be measured from the buccal/mesiobuccal cusp tips to corresponding root apices for premolars and molars respectively.
Time Frame
6 months
Title
Vertical skeletal measurements radiographically in millimeters or angles according to the measurement.
Description
SN/MP: change in mandibular plane inclination relative to the cranial base. MMA: change in mandibular plane inclination relative to the maxillary plane. LAFH: change in lower anterior facial height.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skeletal open bite with a dental open bite ranging from 3-8 mm. Adequate incisal show at rest and on smiling Full set of posterior teeth from first premolar to second molar (with the exception of one tooth in one quadrant). Exclusion Criteria: Dental open bites without skeletal components Previous orthodontic treatment Medically compromised patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba Akl, MSc.
Organizational Affiliation
Assistant lecturer, PhD candidate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthodontic Department, Faculty of Dentistry, Cairo University
City
Cairo
ZIP/Postal Code
11451
Country
Egypt

12. IPD Sharing Statement

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Maxillary Versus Bi-Maxillary Posterior Segments Intrusion Adult Subjects With Skeletal Open Bite

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