Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06520280

Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture

The objective of the trial is to compare between of polyamide and rapidly prototyped (3D-printed) complete denture bases regarding retention, patient satisfaction, masticatory efficiency and microbial adhesion.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

45 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine

Cairo, Naser City, Egypt

About this study

completely edentulous male patients will be selected from the out patient clinic of Removable Prosthodontic Department, Faculty of Oral and Dental medicine Al-Azhar University (Boys), Cairo, Egypt. patients will be selected and divided into randomly two equal groups and each patient will receive two sets of complete dentures: Group I: First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. Group II: First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed. Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval. Patient satisfaction will be measured for all patients after 1 and 3 months follow up through a validated questionnaire. Masticatory efficiency will be measured by measuring muscle activity of the masseter and anterior fibers of the temporalis muscle on both sides for both dentures at one week, one month and three months after delivery using electromyography with three types of test foods. Microbial adhesion Samples will be collected one month after delivery of dentures, swaps will be taken from the fitting palatal surface of the upper denture, this will be done immediately after removal of the denture.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Completely edentulous male patients ranging from age 45 to 60 years.
  • Angle's Class I skeletal relationship.
  • Well-developed ridge with U-shaped palatal vault and adequate firm mucosa.
  • Last extraction took place six months ago.
  • Normal facial symmetry.
  • Cooperative patients.

Exclusion criteria

  • Temporomandibular disorders.
  • Uncontrolled diabetes.
  • Flabby tissues or sharp mandibular residual ridge.
  • Smokers.
  • Patients with neuromuscular disorders.
  • Patients on chemotherapy or radiotherapy.
  • Severe psychiatric disorders.
  • Angle's class II and III skeletal relationship

Treatment and study plan

polyamide and 3D printed complete denture

Other

pts. receive 2 sets of complete dentures made from polyamide and 3d printed to use

Primary outcomes

  1. retention

    Time frame: 6 months

    Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval.

Sponsors and collaborators

Lead sponsor

Ibrahim Mohamed Ali Ibrahim Abd Elrahman

Other

Registry information

Official study title

Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture Bases Construction Techniques: an in Vivo Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jul 25, 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.

Published trials that share one or more normalized conditions with this study.