Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT03624894
Status:
UNKNOWN
Last Update Posted:
2018-08-10
First Post:
2018-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoral Impressions for Assessment of Wear of Teeth and Restorative Materials.
Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Organization:
Study Overview
Official Title:
Suitability of Intraoral Impressions for Assessment of Wear of Teeth and Restorative Materials Over 60 Months Using the Replica Method and 3-D Laser Equipment.
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
GIC
Brief Summary:
Suitability of intraoral impressions for assessment of wear of teeth and restorative materials over 60 months, using the gypsum replica method and 3-D laser scanning: perspective clinical and laboratory evaluation.
Detailed Description:
The study will assess suitability of intraoral impressions for assessment of wear of artificial dental restorative materials over 60 months. Subjects are recruit from patients that undergo a dental restorations independently from the present study. The sample size of n=65 would enable detection of differences in material and tooth wear greater than 10-13% from the baseline volume of teeth, when compared with volumes of teeth obtained from impressions taken at follow-ups, with the power of 0.8 and for the significance level of p=0.05. Paired t-test or a Wilcoxon signed-rank test is implemented depending on the distribution of the variables, for primary aim of evaluating suitability of polyvinylsiloxane dental impression for determination of wearing of teeth and restorative materials.
Paired t-test for each sub-score or a Wilcoxon-signed rank test is implemented, depending on the distribution of the variables, for secondary aims. Then, if variables are considered also as categorical, a Mc Nemar test for each sub-score will be suggested
Paired t-test for each sub-score or a Wilcoxon-signed rank test is implemented, depending on the distribution of the variables, for secondary aims. Then, if variables are considered also as categorical, a Mc Nemar test for each sub-score will be suggested
Study Oversight
Has Oversight DMC:
True
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?: