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

February 6, 2024 updated by: Heba El-Sayed Kamel Akl, Cairo University

Maxillary Versus Bi-Maxillary Posterior Segments Intrusion in Treatment of Adult Subjects With Skeletal Open Bite - A Randomized Clinical Trial

Compare between bi-maxillary (maxillary and mandibular) posterior dento-alveolar intrusion and maxillary posterior dento-alveolar intrusion as regards open bite closure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11451
        • Orthodontic department, Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Maxillary posterior dento-alveolar intrusion
Mini-screw supported maxillary posterior dento-alveolar intrusion
Procedure: Maxillary posterior dento-alveolar intrusion
Mini-screw supported maxillary or bi-maxillary posterior dento-alveolar intrusion
Other Names:
  • Bi-maxillary posterior dento-alveolar intrusion
Experimental: Bi-maxillary posterior dento-alveolar intrusion
Mini-screw supported bi-maxillary posterior dento-alveolar intrusion
Procedure: Maxillary posterior dento-alveolar intrusion
Mini-screw supported maxillary or bi-maxillary posterior dento-alveolar intrusion
Other Names:
  • Bi-maxillary posterior dento-alveolar intrusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anterior open bite closure
Time Frame: 6 months
The amount of overbite gained as a result of posterior dento-alveolar intrusion
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxillary posterior teeth intrusion radiographically in millimeters.
Time Frame: 6 months
The distance travelled by maxillary premolars and molars of the right and left sides to a reference plane
6 months
Mandibular posterior teeth intrusion radiographically in millimeters.
Time Frame: 6 months
The distance travelled by mandibular premolars and molars of the right and left sides to a reference plane
6 months
Tip and torque of intruded teeth radiographically in degrees.
Time Frame: 6 months
• Torque change is measured as the change in the angle between the long axis of the intruded teeth and the FH plane (for tip) mid-sagittal plane (for torque).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Heba Akl, MSc., Assistant lecturer, PhD candidate

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2098765

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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