NCT05718050

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

January 27, 2023

Last Update Submit

February 6, 2023

Conditions

Mandibular Flexure

Outcome Measures

Primary Outcomes (2)

  • Mandibular Flexure in Occlusal Vertical Dimension (OVD)

    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

    24 hours

  • Mandibular Flexure in maximum opening (MO)

    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

    24 hours

Study Arms (1)

Flexure

EXPERIMENTAL

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

Diagnostic Test: Mandibular flexure evaluation

Interventions

Mandibular flexure evaluationDIAGNOSTIC_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.

Flexure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benemérita Universidad Autónoma de Puebla

Puebla City, 72410, Mexico

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 8, 2023

Study Start

March 21, 2018

Primary Completion

January 20, 2020

Study Completion

May 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)