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

Not Applicable

Completed

• Conditions: Edentulism Nos
• Interventions: Device: complete denture

• Registration Number: NCT04982510
• Lead Sponsor: Cairo University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-29
• Study Start: 2021-08-01
• Primary Completion: 2023-05-27
• Study Completion: 2023-06-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional tray definitive impression	complete denture	-
Thermoplastic tray definitive impression	complete denture	-

Primary Outcome Measures

Name	Time	Method
Maxillary complete denture base retention	2 weeks after denture insertion	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.

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	2 weeks	patient satisfaction data will be collected through questionnaire and graded by Visual analogue scale for both study arms

Trial Locations

Locations (1)

Faculty of Dentistry Cairo University; 🇪🇬 Cairo, Egypt