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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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06520280
Enrollment
10
Registered
2024-07-25
Start date
2023-02-13
Completion date
2025-06-30
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Denture

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.

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.

Interventions

OTHERpolyamide and 3D printed complete denture

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

Sponsors

Ibrahim Mohamed Ali Ibrahim Abd Elrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
45 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
retention6 monthsRetention 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026