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Occlusal Bite Force Changes After Surgical Correction of the Increased Vertical Dimension

Primary Purpose

Orthodontic Appliance

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Mandibular Setback with maxillary impaction
Mandibular setback only
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthodontic Appliance focused on measuring bite force, mandibular prognathism, increased vertical dimension, surgical correction

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adults ≥18 years
  • severe skeletal class III malocclusion
  • patients willing to undergo surgery
  • no systematic medical conditions

Exclusion Criteria:

  • poor oral hygiene
  • heavily restored or endodontically treated first molars

Sites / Locations

  • Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Group 1: - Class III patients with increased vertical relationship These patients were scheduled for bimaxillary surgical procedures (Maxillary advancement and mandibular setback with posterior maxillary impaction) to correct the antero-posterior and vertical skeletal discrepancies.

Group 2: - Class III subjects with normal vertical relationship These patients were scheduled for mandibular setback surgical procedure (with no posterior maxillary impaction) to correct the antero-posterior skeletal discrepancy.

Outcomes

Primary Outcome Measures

Occlusal bite force
measured bilaterally in the first molar region using a portable occlusal force gauge
Number of teeth in contact
measured using double-sided articulation paper strips that was smeared with a thin layer of petroleum jelly

Secondary Outcome Measures

Full Information

First Posted
May 3, 2020
Last Updated
May 3, 2020
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04376645
Brief Title
Occlusal Bite Force Changes After Surgical Correction of the Increased Vertical Dimension
Official Title
A Comparative Assessment of Occlusal Bite Force Changes After Surgical Correction of the Increased Vertical Dimension in Mandibular Prognathism Subjects: A Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology

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
The aim of this study was to record the OBF changes after surgical correction of mandibular prognathism in patients with or without increased vertical skeletal dimensions at different time intervals (T0: before surgery; T1: at debond; T2: 3 months post-retention).
Detailed Description
Forty-two patients who presented to orthodontic clinics with severe Class III skeletal malocclusion and were already into orthodontic preparation for orthognathic surgery were selected to participate in thestudy. Patients were allocated into one of 2 groups as follows: - Group 1: - Class III patients with increased vertical relationship Included 22 patients (8 males, 14 females).These patients were scheduled for bimaxillary surgical procedures (Maxillary advancement and mandibular setback with posterior maxillary impaction) to correct the antero-posterior and vertical skeletal discrepancies. Group 2: - Class III subjects with normal vertical relationship Included 20 patients (8 males, 12 females).These patients were scheduled for mandibular setback surgical procedure (with no posterior maxillary impaction) to correct the antero-posterior skeletal discrepancy. Diagnostic records (orthopantomogram, lateral cephalogram, study casts, clinical photographs) were taken for all subjects before surgery. The same records were taken post surgery just before fixed orthodontic appliance debond. The included patients were treated by orthodontic teaching staff and postgraduate residents at orthodontic clinics/JUST using pre-adjusted edgewise fixed appliance (3M Gemini Uniteks, 0.022" MBT prescription brackets). Bite force was measured bilaterally in the first molar region using a portable occlusal force gauge (GM10, Nagano Keiki, Tokyo, Japan), that consisted of a hydraulic pressure gauge and a biting element made of a vinyl material encased in a polyethylene tube. 3 OBF measurements were recorded on each side and incisally with a 15 second rest between each bite, the average of the three readings was used. Three OBF measurements were considered in the analysis: the maximum OBF (MOBF) achieved by the subject, the averaged OBF on molars (AOBF), and the OBF at the incisal region (IOBF). Number of teeth in contact was measured using double-sided articulation paper strips that was smeared with a thin layer of petroleum jelly prior to its' use so as to improve the visualization of the markings of the contact points that existed in a subject's intercuspal position.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Appliance
Keywords
bite force, mandibular prognathism, increased vertical dimension, surgical correction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were allocated into one of 2 groups as follows: - Group 1: - Class III patients with increased vertical relationship Group 2: - Class III subjects with normal vertical relationship
Masking
None (Open Label)
Masking Description
Blinding was not possible
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1: - Class III patients with increased vertical relationship These patients were scheduled for bimaxillary surgical procedures (Maxillary advancement and mandibular setback with posterior maxillary impaction) to correct the antero-posterior and vertical skeletal discrepancies.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Group 2: - Class III subjects with normal vertical relationship These patients were scheduled for mandibular setback surgical procedure (with no posterior maxillary impaction) to correct the antero-posterior skeletal discrepancy.
Intervention Type
Procedure
Intervention Name(s)
Mandibular Setback with maxillary impaction
Intervention Description
Occlusal bite force will be measured after surgery to correct vertical disproportions
Intervention Type
Procedure
Intervention Name(s)
Mandibular setback only
Intervention Description
Occlusal bite force will be measured after surgery without changing vertical disproportions.
Primary Outcome Measure Information:
Title
Occlusal bite force
Description
measured bilaterally in the first molar region using a portable occlusal force gauge
Time Frame
1 year
Title
Number of teeth in contact
Description
measured using double-sided articulation paper strips that was smeared with a thin layer of petroleum jelly
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults ≥18 years severe skeletal class III malocclusion patients willing to undergo surgery no systematic medical conditions Exclusion Criteria: poor oral hygiene heavily restored or endodontically treated first molars
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elham Abu Alhaija, PhD
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics
City
Irbid
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Occlusal Bite Force Changes After Surgical Correction of the Increased Vertical Dimension

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