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Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture

I

Ibrahim Mohamed Ali Ibrahim Abd Elrahman

Status

Active, not recruiting

Conditions

Complete Denture

Treatments

Other: polyamide and 3D printed complete denture

Study type

Interventional

Funder types

Other

Identifiers

NCT06520280
875/281

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Male

Ages

45 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

10 participants in 2 patient groups

GroupI
Other group
Description:
First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin.
Treatment:
Other: polyamide and 3D printed complete denture
Group II
Other group
Description:
First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed
Treatment:
Other: polyamide and 3D printed complete denture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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