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OpenTrials
Completed

NCT Number: NCT04982510

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

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

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Key information

Conditions

Edentulism Nos

Age range

Up to 69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

complete denture

Device

3D printed complete denture

Primary outcomes

  1. Maxillary complete denture base retention

    Time frame: 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 outcomes

  1. Patient satisfaction

    Time frame: 2 weeks

    patient satisfaction data will be collected through questionnaire and graded by Visual analogue scale for both study arms

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2021
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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