Skip to main content
OpenTrials
Completed

NCT Number: NCT04376645

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular Setback with maxillary impaction

Procedure

Occlusal bite force will be measured after surgery to correct vertical disproportions

Mandibular setback only

Procedure

Occlusal bite force will be measured after surgery without changing vertical disproportions.

Primary outcomes

  1. Occlusal bite force

    Time frame: 1 year

    measured bilaterally in the first molar region using a portable occlusal force gauge

  2. 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

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.