Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Complete Denture
• Intervention / Treatment: Other: polyamide and 3D printed complete denture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Naser City
    • Cairo, Naser City, Egypt
      • Faculty of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Temporomandibular disorders.
2. Uncontrolled diabetes.
3. Flabby tissues or sharp mandibular residual ridge.
4. Smokers.
5. Patients with neuromuscular disorders.
6. Patients on chemotherapy or radiotherapy.
7. Severe psychiatric disorders.
8. Angle's class II and III skeletal relationship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GroupI; First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin.	Other: polyamide and 3D printed complete denture; pts. receive 2 sets of complete dentures made from polyamide and 3d printed to use
Other: Group II; First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed	Other: polyamide and 3D printed complete denture; pts. receive 2 sets of complete dentures made from polyamide and 3d printed to use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention	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.	6 months

Collaborators and Investigators

• Sponsor: Ibrahim Mohamed Ali Ibrahim Abd Elrahman
• Investigators: Study Director: mohamed helal, professor, AZU

Publications and helpful links

Helpful Links

• comparison of retention between maxillary milled and conventional denture bases: A clinical study.
• Accuracy and retention of denture base fabricated by heat curing and additive manufacturing.
• Comparison between Retention of Maxillary Acrylic and Nylon Denture Base Materials.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: July 21, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 875/281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No