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NCT01268605 · ClinicalTrials.gov registry record · Phase 3
Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
A Phase 3 study, sponsored by Pearl Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 341
- Enrollment target
NCT01268605: Completed Phase 3 study, sponsored by Pearl Network.
NCT01268605 is a Phase 3 study that has completed, run by Pearl Network. The registered enrollment target is 341 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01268605, a Phase 3 study, has completed, sponsored by Pearl Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 341 participants
- Enrollment target
Study 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 reduction/elimination 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.
Primary Outcome
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.
Interventions
- PROCEDURE Restoration with a dentin bonding agent (DBA)
- PROCEDURE Restoration with a resin modified glass ionomer liner (RMGI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 341 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT01268605 record still lists
NCT01268605 is an interventional study that assigns participants to a tested intervention. The registered 341 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Restoration with a dentin bonding agent (DBA) is the first listed.
NCT01268605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01268605 about?
NCT01268605 is a clinical study titled "Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial". 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 (RCE...
What is the current status of trial NCT01268605?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 341 participants. The study started on 2010-09. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01268605?
The interventions under investigation include: Restoration with a dentin bonding agent (DBA) (PROCEDURE), Restoration with a resin modified glass ionomer liner (RMGI) (PROCEDURE).
Who is sponsoring clinical trial NCT01268605?
This trial is sponsored by Pearl Network, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01268605's enrollment target sits among peer trials
341 1053rd of 2000 higher than 948 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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