Ignite Creation Date:
2024-05-05 @ 9:19 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00867997
Status:
COMPLETED
Last Update Posted:
2012-02-29
First Post:
2009-03-23
Brief Title:
Noncarious Cervical Lesion Treatment Outcomes
Sponsor:
Pearl Network
Organization:
Pearl Network
Study Overview
Official Title:
Noncarious Cervical Lesion Treatment Outcomes Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2012-02
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 overall objective of this three-armed randomized clinical trial RCT is to determine the comparative efficacy of three treatments for hypersensitive noncarious cervical lesions NCLs chemoactive dentifrice use dentin bonding agent DBA with sealing and flowable resin-based composite restoration The primary outcomes of this study are the reductionelimination of hypersensitivity and the effect of treatment as measured by patient-reported outcomes Secondary outcomes as determined by laboratory evaluation of intraoral replicas of pre- and posttreatment NCL surfaces are tubule occlusion retention of resin coating retention of restoration and change in lesion size Outcomes will be ascertained via the following specific aims
Specific Aim 1 To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups
Specific Aim 2 To recruit subjects with teeth with hypersensitive NCLs measure baseline sensitivity and subject quality of life administer one of three different treatments to each of three randomized groups of subjects and determine immediate posttreatment hypersensitivity
Specific Aim 3 To compare the degree of tubule occlusion before and after the three treatments and to associate these findings with posttreatment hypersensitivity patient-reported outcomes and restoration retention
Treatment of NCLs remains controversial Few studies have compared treatment methods or their financial implications This RCT will determine the reduction of NCL hypersensitivity and patient-reported outcomes over a 6-month period for each of three different treatments This will be the first practice-based research network RCT to combine objective clinical assessment of NCL treatment patient-reported outcomes with laboratory examination of dentin tubule occlusion and lesion size
Specific Aim 1 To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups
Specific Aim 2 To recruit subjects with teeth with hypersensitive NCLs measure baseline sensitivity and subject quality of life administer one of three different treatments to each of three randomized groups of subjects and determine immediate posttreatment hypersensitivity
Specific Aim 3 To compare the degree of tubule occlusion before and after the three treatments and to associate these findings with posttreatment hypersensitivity patient-reported outcomes and restoration retention
Treatment of NCLs remains controversial Few studies have compared treatment methods or their financial implications This RCT will determine the reduction of NCL hypersensitivity and patient-reported outcomes over a 6-month period for each of three different treatments This will be the first practice-based research network RCT to combine objective clinical assessment of NCL treatment patient-reported outcomes with laboratory examination of dentin tubule occlusion and lesion size
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 |
|---|---|---|---|
| 116358 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01DE016755 |
| U01DE016755 | NIH | None | None |