Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05990088
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-07-22
Brief Title:
Comparison Between Conventional and CADCAM Complete Dentures Designed Based on Neutral Zone Concept
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Comparison of Electromyographic Muscle Activity and Occlusal Accuracy Between Conventional and CADCAM Complete Dentures Designed Based on Neutral Zone Concept 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:
None
Brief Summary:
A within-subject cross-over study is done on eight completely edentulous patients to compare two different complete removable dentures Group I Heat cured Conventional complete dentures designed based on the neutral zone concept Group II CAD-CAM neutral zone complete dentures designed based on the neutral zone concept Occlusal analysis is done by the T-Scan device and evaluation of muscle activity is conducted by electromyography at insertion time two weeks after insertion time and one month after insertion time
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 Heat cured Conventional complete dentures designed based on the neutral zone concept group II CAD-CAM neutral zone complete dentures designed based on the neutral zone concept The study will be carried out on eight completely edentulous patients each patient will receive two sets of complete dentures in a random sequence For each denture set at the denture insertion visit occlusal analysis and equilibration will be performed with the aid of the T-Scan device also EMG evaluation of muscle activity will be conducted Two weeks after the patients will be recalled to reanalyze the occlusion after the denture settles using the T-scan computerized system One month after the last recall visit the EMG evaluation of muscle activity will be conducted again The EMG and T-scan recording data will be collected and analyzed to compare the two denture types
Study Oversight
Has Oversight DMC:
None
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?:
None