Accuracy of 3D Printed Complete Dentures Using Two Impression Techniques: RCT

Retention of 3D Printed Bases Using Prefabricated Thermoplastic Trays and Conventional Custom Impression Trays: Randomized Controlled Trial

the aim of this crossover randomized controlled clinical trial is comparing retention of 3D printed maxillary complete dentures produced from thermoplastic impression trays and conventional acrylic impression trays.

The research hypothesis is that there is no difference in patient satisfaction and retention of dentures constructed from definitive impression using the conventional tray and the prefabricated thermoplastic tray

Study Overview

• Status: Completed
• Conditions: Edentulism Nos
• Intervention / Treatment: Device: complete denture

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 69 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male edentulous patients.
• Cooperative and highly motivated patients.
• Patients with well or moderately developed ridges and healthy attached mucosa of appropriate thickness free from inflammation

Exclusion Criteria:

• Patients with recent extraction less than 3 months ago
• Patients with Parkinson's disease
• Patients with xerostomia.
• Patients with allergy to resins.
• Pathological changes of residual ridges.
• Patient with sever undercuts, or irregular bony exostosis.
• Patients with flabby and flat ridges.
• Patients with medical or psychological conditions that hinder co-operation.
• Patients with class II or III jaw relation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermoplastic tray definitive impression	Device: complete denture; 3D printed complete denture
Active Comparator: Conventional tray definitive impression	Device: complete denture; 3D printed complete denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maxillary complete denture base retention	A loop will be attached to each denture base at the position of geographic center using self cure acrylic resin and the retention will be measured by applying the forces perpendicular to the denture using Digital Force Meter Each base will be tested 3 times and the average will be calculated.	2 weeks after denture insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	patient satisfaction data will be collected through questionnaire and graded by Visual analogue scale for both study arms	2 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): May 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: digital dentures, definitive impression, thermoplastic trays, printed denture, 3D, rapid prototyping
• Other Study ID Numbers: 4421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No