Digital Assessment of Mandibular Flexure in Full Arch Fixed Restorations

November 13, 2022 updated by: Medhat Sameh Abdelaziz, Future University in Egypt

Retrospective Digital Study of Mandibular Flexure in Patients With Long-span Fixed Restorations Supported by Natural Teeth.

Nine patients (five males and four females) were included in this study who had long-term (10-15 years) of long-span rigid mandibular fixed prostheses that may have led to radiographic changes around the supporting teeth. The treatment plans included the removal of the long-span fixed rigid prostheses followed by restoring the patients with segmented implant-supported prostheses. In order to digitally measure the mandibular flexure, reference markers were adhered to the prostheses, and intraoral scans were obtained before and after splitting the preexisting prostheses at the minimum and maximum mouth opening. The distances between the markers were measured, and mandibular flexure was calculated by subtracting the distance between the markers during the maximum mouth opening from the minimum mouth opening. An independent sample T-test was used to compare mandibular flexure before and after splitting the long-span fixed prostheses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

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

  • Egypt
      • Cairo, Egypt, 111111
        • Future University in Egypt

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All had the entire mandibular natural dentition (6-8 abutments) splinted with a single-unit metal-ceramic (long-span fixed prosthesis). All of them suffered from different negative consequences of their one-piece fixed restorations. The retrospective collection of the patient's data was tabulated and analyzed. Nine patients were included in this study. Five males and four females, with an age range of 50-76 years were enrolled in this study.

Description

Inclusion Criteria:

  • full-arch mandibular single fixed prostheses that served for many years (average 12 years) opposed by natural dentition.
  • Patients were free from any systemic or debilitating diseases such as bone diseases, diabetes melilites, or blood dyscrasias.

Exclusion Criteria:

  • patients with healthy fixed full-arch prosthesis
  • patients with segmented prosthesis
  • patients with systematic debilitating diseases.
  • Patients with temporomandibular joint dysfunction, maxillofacial surgeries, or mandibular trauma.

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mandibular flexure before sectioning of full arch fixed prosthesis
Mandibular flexure after sectioning of full arch fixed prosthesis
Procedure: Sectioning of the full arch mandibular fixed prosthesis
The one unit full arch fixed prosthesis is sectioned at the midline into two pieces

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in mandibular flexure
Time Frame: immediately after the splitting of the full arch fixed prosthesis.
change in mandibular flexure before and after splitting of the fixed full arch prosthesis
immediately after the splitting of the full arch fixed prosthesis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

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)

January 20, 2021

Primary Completion (Actual)

October 26, 2022

Study Completion (Actual)

October 26, 2022

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 13, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FUE.REC(26)/10-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

study protocol, raw data,statistics

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

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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