- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05718050
Mandibular Flexure in Patients
February 6, 2023 updated by: Paolo Carosi, University of Rome Tor Vergata
Mandibular Flexure: An In-vivo Study in Dentate 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Puebla, Mexico, 72410
- Benemérita Universidad Autónoma de Puebla
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Flexure
Dentate patients, 18 years of age or older, in good health and, in need of implant treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours
|
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
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 21, 2018
Primary Completion (ACTUAL)
January 20, 2020
Study Completion (ACTUAL)
May 1, 2022
Study Registration Dates
First Submitted
January 27, 2023
First Submitted That Met QC Criteria
February 6, 2023
First Posted (ACTUAL)
February 8, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2018065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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