Digital Assessment of Mandibular Flexure in Full Arch Fixed Restorations

NCT05617274 | Completed

• 1 other identifier: FUE.REC(26)/10-2022
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mandibular Flexure; Full Arch Fixed Prosthesis

Keywords

Mandibular flexure; Prosthesis Failure; Full arch restorations

Outcome Measures

Primary Outcomes (1)

• change in mandibular flexure

  change in mandibular flexure before and after splitting of the fixed full arch prosthesis

  immediately after the splitting of the full arch fixed prosthesis.

Study Arms (2)

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

Interventions

Sectioning of the full arch mandibular fixed prosthesis PROCEDURE

The one unit full arch fixed prosthesis is sectioned at the midline into two pieces

Mandibular flexure after sectioning of full arch fixed prosthesis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, 111111, Egypt

Location

Related Publications (1)

• El Charkawi H, Nassar HI, Abdelaziz MS. Retrospective digital study of mandibular flexure in patients with long-span fixed restorations supported by natural teeth. BMC Res Notes. 2023 Sep 11;16(1):203. doi: 10.1186/s13104-023-06486-w.

  PMID: 37697386 DERIVED

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 15, 2022
• Study Start: January 20, 2021
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)