Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-15
Brief Title:
Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients one digitally constructed using digital smile design DSD and another one conventionally constructed on the patients quality of life and patients satisfaction
It is a clinical trial in which two dentures will be made for each patient one will be digitally constructed using digital smile design DSD and the other one using the conventional method with a washout period of 3 weeks Each patient will receive a questionnaire Oral Health Impact Profile -19 OHIP -19 for the edentulous patients to evaluate his satisfaction with the denture
It is a clinical trial in which two dentures will be made for each patient one will be digitally constructed using digital smile design DSD and the other one using the conventional method with a washout period of 3 weeks Each patient will receive a questionnaire Oral Health Impact Profile -19 OHIP -19 for the edentulous patients to evaluate his satisfaction with the denture
Detailed Description:
Although the aesthetic results of digitally constructed dentures might be satisfactory for the patients there is still little clinical evidence for the effect of using digital smile design DSD in denture construction on the patients satisfaction So the objective of the current study is to find the effect of digital smile design DSD on quality of life in complete denture wearers compared to the conventionally created one The current study is planned to be a crossover randomized Controlled Trial RCT The principal investigator participants and the statistician will be blinded Simple randomization of the patients in the will take place using a computer generated list Software informer Informer Technologies Inc and allocated into two groups a conventional denture followed by a digital group CG and a digital denture followed by a conventional one group DG Parallel allocation in ratio 11 will take place The names of the participants in both groups will be placed in closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient For blinding and allocation concealment a third party rather than the authors and participants will be the only one to know the key so that the authors and the participants wont know in which group the participant will be Afterwards the authors will be informed by the randomization to be tabulated
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