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OpenTrials
Completed

NCT Number: NCT05718050

Mandibular Flexure in Patients

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.

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Key information

Conditions

Mandibular Flexure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benemérita Universidad Autónoma de Puebla

Puebla City, 72410, Mexico

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Mandibular flexure evaluation

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.

Primary outcomes

  1. Mandibular Flexure in Occlusal Vertical Dimension (OVD)

    Time frame: 24 hours

    A blind assessor made 4 four measurements per patient on an implant planning software (DTX Studio Implant software, Dexis LLC), evaluating the distance between the fiducial landmark at the contralateral canines and contralateral molars, and between ipsilateral canines and molars on both sides

  2. Mandibular Flexure in maximum opening (MO)

    Time frame: 24 hours

    A blind assessor made 4 four measurements per patient on an implant planning software (DTX Studio Implant software, Dexis LLC), evaluating the distance between the fiducial landmark at the contralateral canines and contralateral molars, and between ipsilateral canines and molars on both sides

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

Mandibular Flexure: An In-vivo Study in Dentate Patients.

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Feb 8, 2023
Registry last updated
Feb 8, 2023

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.

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