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

May 3, 2020 updated by: Elham Abu Alhaija, Jordan University of Science and Technology

A Comparative Assessment of Occlusal Bite Force Changes After Surgical Correction of the Increased Vertical Dimension in Mandibular Prognathism Subjects: A Prospective Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

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

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

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

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
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.
Procedure: Mandibular Setback with maxillary impaction
Occlusal bite force will be measured after surgery to correct vertical disproportions
Experimental: Group 2
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.
Procedure: Mandibular setback only
Occlusal bite force will be measured after surgery without changing vertical disproportions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal bite force
Time Frame: 1 year
measured bilaterally in the first molar region using a portable occlusal force gauge
1 year
Number of teeth in contact
Time Frame: 1 year
measured using double-sided articulation paper strips that was smeared with a thin layer of petroleum jelly
1 year

Collaborators and Investigators

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

Sponsor

Jordan University of Science and Technology

Investigators

  • Principal Investigator: Elham Abu Alhaija, PhD, Jordan University of Science and Technology

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 1, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 3, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 44/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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