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
1 other identifier
interventional
11
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 29, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2023
CompletedFebruary 8, 2024
February 1, 2024
1.8 years
July 15, 2021
February 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Patient satisfaction
2 weeks
Study Arms (2)
Thermoplastic tray definitive impression
EXPERIMENTALConventional tray definitive impression
ACTIVE COMPARATORInterventions
3D printed complete denture
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Dentistry Cairo University
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 15, 2021
First Posted
July 29, 2021
Study Start
August 1, 2021
Primary Completion
May 27, 2023
Study Completion
June 27, 2023
Last Updated
February 8, 2024
Record last verified: 2024-02