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Mandibular Flexure in Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05718050
Enrollment
21
Registered
2023-02-08
Start date
2018-03-21
Completion date
2022-05-01
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Flexure

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.

Interventions

DIAGNOSTIC_TESTMandibular 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.

Sponsors

University of Rome Tor Vergata
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Mandibular Flexure in Occlusal Vertical Dimension (OVD)24 hoursA 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
Mandibular Flexure in maximum opening (MO)24 hoursA 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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026