Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520280
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture Bases Construction Techniques an in Vivo Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None