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CompletedNCT04376645Updated May 6, 2020

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

An interventional study of Mandibular Setback with maxillary impaction and Mandibular setback only in Orthodontic Appliance, sponsored by Jordan University of Science and Technology. Completed at 1 site in Jordan. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-06.

Sponsored by Jordan University of Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Sep 2018, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Orthodontic Appliance

Keywords

  • bite force
  • mandibular prognathism
  • increased vertical dimension
  • surgical correction
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's enrollment of 40 is above the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

Jordan University of Science and Technology is the lead sponsor of 89 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • poor oral hygiene
  • heavily restored or endodontically treated first molars
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureMandibular Setback with maxillary impaction

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

  • ProcedureMandibular setback only

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

06

What researchers measure

Primary outcomes

  1. Occlusal bite force

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

    Time frame: 1 year

  2. Number of teeth in contact

    measured using double-sided articulation paper strips that was smeared with a thin layer of petroleum jelly

    Time frame: 1 year

07

Study locations

1 site
  • Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics
    Irbid, Jordan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04376645
Lead sponsor
Jordan University of Science and Technology
Responsible party
Elham Abu Alhaija (Professor, Jordan University of Science and Technology) — Principal investigator
First posted
May 6, 2020
Start date
Sep 1, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
May 6, 2020

Study contacts

Elham Abu Alhaija, PhD
principal investigator · Jordan University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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