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

Study Overview
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Brief Summary
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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

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

Conditions
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Edentulism Nos

Intervention / Treatment
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* Device: complete denture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermoplastic tray definitive impression<br> | Device: complete denture<br>* 3D printed complete denture<br>|
| Active Comparator: Conventional tray definitive impression<br> | Device: complete denture<br>* 3D printed complete denture<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital dentures, definitive impression, thermoplastic trays, printed denture, 3D, rapid prototyping