Mandibular Flexure in Patients

NCT ID: NCT05718050

Last Updated: 2023-02-08

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2022-05-01

Brief Summary

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The flexion of the mandible (MF) is a multifactorial phenomenon that occurs simultaneously with mandibular movements determining changes in the shape of the mandible. mandibular flexure (MF) may cause complications and failures in both conventional and implant-supported fixed dental prostheses (FDP) especially when a long-span prosthesis is planned to connect the anterior to the posterior region of the mandible. Previous studies reported increased biomechanical stress at the prosthetic and implant level, poor passivity of fit, impression distortion, pain during function, de-cementation of the prosthesis, porcelain chipping, prosthetic screw loosening and fracture, bone resorption and implant fracture. The aim of this study is to quantify the dimensional changes related to MF by means of a cone beam computed tomography (CBCT) between maximum opening (MO) and maximum intercuspation (OVD) positions. The null hypothesis was that there is no significant difference in terms of length and width of the mandible between maximum intercuspation and maximum opening positions.

Detailed Description

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Conditions

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Mandibular Flexure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Flexure

Dentate patients, 18 years of age or older, in good health and, in need of implant treatment

Group Type EXPERIMENTAL

Mandibular flexure evaluation

Intervention Type DIAGNOSTIC_TEST

A mandibular silicon impression was taken, and a vacuum molded thermoplastic stent with radiopaque fiducial markers (steel ball bearings) on the facial side of the canines and molars was fabricated for each patient. Two Cone Beam Computed Tomographs (CBCTs) were made per patient with their radiographic stent in the mouth at the OVD and MO positions at the University Advanced Digital Diagnostic Center. The CBCT examination was performed without any stitching procedure using a computed tomography (SCANORA 3DX; Dexis LLC) set up at 90 kV, 4 mA and a field of view (FOV) of 140 and 100 mm in height and width respectively, to decrease the radiation dose without affecting the quality of the examination.

Interventions

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Mandibular flexure evaluation

A mandibular silicon impression was taken, and a vacuum molded thermoplastic stent with radiopaque fiducial markers (steel ball bearings) on the facial side of the canines and molars was fabricated for each patient. Two Cone Beam Computed Tomographs (CBCTs) were made per patient with their radiographic stent in the mouth at the OVD and MO positions at the University Advanced Digital Diagnostic Center. The CBCT examination was performed without any stitching procedure using a computed tomography (SCANORA 3DX; Dexis LLC) set up at 90 kV, 4 mA and a field of view (FOV) of 140 and 100 mm in height and width respectively, to decrease the radiation dose without affecting the quality of the examination.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Dentate patients,
* 18 years of age or older,
* Good health
* Need of implant treatment

Exclusion Criteria

* active periodontitis with tooth mobility
* neuromuscular disorders
* temporomandibular joint disorders
* parafunctional habits
* systemic condition preventing surgery
* history of oro-maxillofacial radiation therapy
* history of drug or alcohol abuse
* heavy smoking
* uncontrolled diabetes
* pregnancy
* lactation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Paolo Carosi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benemérita Universidad Autónoma de Puebla

Puebla City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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2018065

Identifier Type: -

Identifier Source: org_study_id

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