Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-26 @ 7:04 AM
Study NCT ID:
NCT05895292
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Digital Analysis of Denture Space Confines and Patient's Satisfaction for Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges.(Randomized Controlled Clinical Trial)
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAD/CAM
Brief Summary:
The study is a within-subject randomized clinical trial that will compare and evaluate patients' satisfaction and digitally analyze denture space Confines. Group I: CAD/CAM. (computer-aided design/computer-aided manufacturing) Conventional complete dentures will be designed based on the bone support concept, Group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.
Detailed Description:
This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: CAD/CAM conventional complete dentures will be designed based on the bone support concept, group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The study will be carried out on twelve completely edentulous patients exhibiting advanced residual ridge resorption, each patient will receive two sets of complete dentures in a random sequence, and each set of CDs will be worn for at least eight weeks after the last recall visit before assessments. Upon delivery of the second set of CDs, the first set will be withheld from the patient. For each denture set, patient satisfaction will be rated using a patient denture assessment PDA questionnaire that will be assessed via a Likert scale, the obtained scores will be used to compare the two denture types. Also by using special digital software, a comparison between group I and II virtual complete denture images will be conducted.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: