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

Edentulism Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04982510
• Other study ID #: 4421
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: June 27, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 27, 2023
• Est. primary completion date: May 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edentulism Nos

Intervention

Device:
• complete denture
3D printed complete denture

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction	patient satisfaction data will be collected through questionnaire and graded by Visual analogue scale for both study arms	2 weeks