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

NCT ID: NCT04376645

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Orthodontic Appliance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Blinding was not possible

Study Groups

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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.

Group Type EXPERIMENTAL

Mandibular Setback with maxillary impaction

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Mandibular setback only

Intervention Type PROCEDURE

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

Interventions

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Mandibular Setback with maxillary impaction

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

Intervention Type PROCEDURE

Mandibular setback only

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Elham Abu Alhaija

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elham Abu Alhaija, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

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

Irbid, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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44/2018

Identifier Type: -

Identifier Source: org_study_id

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