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

NCT04376645 | Completed

• 1 other identifier: 44/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Orthodontic Appliance

Keywords

bite force; mandibular prognathism; increased vertical dimension; surgical correction

Outcome Measures

Primary Outcomes (2)

• Occlusal bite force

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

  1 year

• Number of teeth in contact

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

  1 year

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Mandibular Setback with maxillary impaction PROCEDURE

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

Group 1

Mandibular setback only PROCEDURE

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

Group 2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

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

Irbid, Jordan

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Elham Abu Alhaija, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Blinding was not possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 6, 2020
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)