Three Dimensional Printed Versus Conventional Heat Cured Acrylic Complete Denture

NCT05585008 | Completed DMC

• 1 other identifier: 318/2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: One major complaint frequently voiced by complete denture wearers is denture retention. Conventional denture disadvantage is heat-curing resin deformation. In addition, the pack and press technique that is still more common, residual stresses that occur at the time of packing are released when the material is removed from the flask, causing the resin to shrink, and this shrinkage is cited as a cause of poor fit of the denture base, In the field of prosthetic dentistry, the ability of additive manufacturing to fabricate prosthetic devices based on CAD data influences the overall quality, the mechanical properties of printed parts, the total cost and the manufacturing time. The milling process wastes large quantities of denture base material, and more recent three-dimensional (3D) prototyping promises a more sustainable additive approach by using less denture resin. However, no clinical reports have been published regarding the accuracy of the mucosal surface or denture retention for denture fabricated using conventional techniques compared to those fabricated using additive manufacturing. Aim of the study: Investigate the effect of two techniques of complete denture manufacturing (conventional and 3D printed) on denture retention, trueness (accuracy), and satisfaction. Methodology: Twenty patients will be selected from the outpatient clinic and will be divided into 2 groups, group A for conventional dentures and group B for 3D printed dentures, retention for the two groups will be measured at 0,1 and 3 months, and patient satisfaction will be recorded, and accuracy of the denture base will be measured on the software. The results will be tabulated and statistically analyzed using the SPSS program.

Conditions

Completely Edentulous Patients

Keywords

3d printing; CAD-CAM; retention; adaptation; denture

Outcome Measures

Primary Outcomes (3)

• accuracy of fit (adaptation)

  the deviation of the denture fiitng surface from its corresponding cast will be measured using metrology software (GOM inspect,USA))

  1 week

• retention

  retention will be measured using digital force gauge(weihang electronic gauge,weihang industries, china)

  3 months

• patient satisfaction

  Participants will answer a denture satisfaction questionnaire. Possible answers for each question and respective scores will be: unsatisfactory =0, regular =1, and good =2 (Rehmann et al., 2008)

  3 months

Secondary Outcomes (1)

• retention over time period

  3 months

Study Arms (2)

group A

ACTIVE COMPARATOR

group A will receive a conventional heat-cure acrylic denture

Device: two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia))

group B

ACTIVE COMPARATOR

group B will receive a 3D printed complete denture

Device: two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia))

Interventions

two different denture manufacturing technique (heat cure pack and press technique(heat cure acrylic,Acrostone,Egypt)/3d printed dneture(HARZ lab,Russia)) DEVICE

retention for the two groups will be measured at 0,1 and 3months, patient satisfaction will be recorded, and accuracy of the denture base will be measured on the software.

group A; group B

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with good neuromuscular control and free of systemic diseases
• the edentulous ridge was covered with healthy firm and dense mucosa
• They have upper and lower edentulous healthy alveolar ridges with no remaining roots, no severe bony undercut, or local pathological lesions.
• patients had no previous dentures with a nearly equal edentulous period.

You may not qualify if:

• history of bad habits e.g. severe clenching.
• T.M.J disorders
• patients with xerostomia, high palatal vault, and short or hyperactive lips were excluded.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry,Suez Canal University

Bilbeis, Sharqia Province, 46213, Egypt

Location

Related Publications (1)

• Goodacre BJ, Goodacre CJ, Baba NZ, Kattadiyil MT. Comparison of denture base adaptation between CAD-CAM and conventional fabrication techniques. J Prosthet Dent. 2016 Aug;116(2):249-56. doi: 10.1016/j.prosdent.2016.02.017. Epub 2016 Apr 23.

  PMID: 27112416 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 18, 2022
• Study Start: August 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)