Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture

NCT06520280 | Active Not Recruiting

• 1 other identifier: 875/281
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complete Denture

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

GroupI

OTHER

First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin.

Other: polyamide and 3D printed complete denture

Group II

OTHER

First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed

Other: polyamide and 3D printed complete denture

Interventions

polyamide and 3D printed complete denture OTHER

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

Group II; GroupI

Eligibility Criteria

• Age: 45 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ibrahim Mohamed Ali Ibrahim Abd Elrahman: lead

Study Sites (1)

Faculty of Dental Medicine

Cairo, Naser City, Egypt

Location

Related 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.

MeSH Terms

Interventions

Nylons

Intervention Hierarchy (Ancestors)

Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• mohamed helal, professor

  AZU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: prosthodontist

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 25, 2024
• Study Start: February 13, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)