Ignite Creation Date:
2024-05-05 @ 11:09 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01268605
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2010-10-19
Brief Title:
Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
Sponsor:
Pearl Network
Organization:
Pearl Network
Study Overview
Official Title:
Resin Based Composite Occlusal Restoration Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
Status:
COMPLETED
Status Verified Date:
2014-09
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:
POH RCERT
Brief Summary:
Postoperative hypersensitivity POH is a problem for many patients as determined by the recent Practitioners Engaged in Applied Research and Learning PEARL study of POH following occlusal caries restoration The objectives of this two-armed randomized comparative effectiveness research trial RCERT are to determine whether adding a resin modified glass ionomer liner RMGI reduces POH in dentin bonded Class I resin based composite RBC restorations and to identify other factors putative risk factors that are associated with increased POH
The primary outcome of this study is the reductionelimination of restoration POH as measured by clinical assessment air stream and patient-reports
Outcomes will be ascertained via the following specific aims
Specific Aim 1 To compare the reduction of hypersensitivity of study teeth by clinical measurement air drying and by patient-reported outcomes among the two treatment groups at three points in time prior to restoration and at one and four weeks postrestoration
Specific Aim 2 To identify putative risk factors for POH or factors associated with differences in POH including preoperative caries stage measured by the proposed American Dental Association ADA Caries Classification System CCS lesion depth as measured on the preoperative radiograph dentin caries activity ranked on opening the lesion preparation depth and patient sleep bruxism status
The primary outcome of this study is the reductionelimination of restoration POH as measured by clinical assessment air stream and patient-reports
Outcomes will be ascertained via the following specific aims
Specific Aim 1 To compare the reduction of hypersensitivity of study teeth by clinical measurement air drying and by patient-reported outcomes among the two treatment groups at three points in time prior to restoration and at one and four weeks postrestoration
Specific Aim 2 To identify putative risk factors for POH or factors associated with differences in POH including preoperative caries stage measured by the proposed American Dental Association ADA Caries Classification System CCS lesion depth as measured on the preoperative radiograph dentin caries activity ranked on opening the lesion preparation depth and patient sleep bruxism status
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 136277 | OTHER_GRANT | NIDCR | httpsreporternihgovquickSearchU01DE016755 |
| U01DE016755 | NIH | None | None |