Evaluation of Digital 3D Printed Temporary Removable Partial Denture.

October 27, 2023 updated by: Medhat Sameh Shehata Abdelaziz, Cairo University

Oral Health-Related Quality of Life and Retention in Digitally Versus Conventionally Fabricated Flexible Removable Partial Dentures in Maxillary Class III Modification 1 Patients: A Cross-over Randomized Clinical Trial

This study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible RDPs and conventionally-fabricated temporary flexible RDPs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

13

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 Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Faculty of Dentistry , Cairo University
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Maxillary Class III, modification I partially edentulous patients that enables measuring the retention values intraorally without denture rotation.
  • Fully dentulous or partially edentulous opposing mandibular arch.
  • Patients that require temporary partial dentures for aesthetic reasons or as an interim denture during mouth rehabilitation treatment or after implant placement.
  • Age range (30-55 years).
  • Cooperative patients that are willing to attend all follow-up periods.
  • Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
  • Patients with healthy abutments and healthy periodontium and no more than grade I mobility.

Exclusion Criteria:

  • Patients with Parkinson's disease
  • Patients with xerostomia.
  • Patients with a history of allergy to dentures made of resins.
  • Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
  • Patients with large irregular bony exostosis.
  • Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The conventional heat pressing temporary flexible maxillary removable partial denture
Procedure: The conventional heat pressing temporary flexible maxillary removable partial denture
An intraoral scan will be made for each patient's maxillary and mandibular jaws in addition to digital bite registration using (Medit i700; Medit corp.) the resultant data will be exported in the form of a Standard Tessellation Language (STL) file. The denture base and the teeth will be designed using computer-aided design software (Partial Cad, Dental CAD software). Each patient will receive two RDPs, fabricated with two different manufacturing techniques. Based on randomization, the patients will start by receiving either partial denture that is fabricated by conventional heat pressing technique of 3D printed castable resin (Cast V1resin) followed by partial denture that is fabricated by 3D printing of printable resin (Flexo denture base, resin) and teeth (permanent crown,resin) or the other way around. In 3D-printed RDP, the artificial teeth will be attached to the fabricated denture bases using printable denture base resin material
Experimental: 3D-printed and digitally designed temporary flexible maxillary removable partial denture .
Procedure: 3D-printed and digitally designed temporary flexible maxillary removable partial denture
3D-printed and digitally designed temporary flexible maxillary removable partial denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral health-related quality of life.
Time Frame: Baseline and 6 months
Oral health impact profile (OHIP 14) questionnaire will be used to asses the oral health-related quality of life
Baseline and 6 months
Retention of a removable partial denture
Time Frame: Baseline and 6 months
The retention will be measured using Digital Force Gauge attached to the denture polished surface while the patient is in supine position
Baseline and 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

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)

June 2, 2023

Primary Completion (Estimated)

August 2, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

October 30, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 7-7-23

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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