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NCT00867997 · ClinicalTrials.gov registry record · Phase 3
Noncarious Cervical Lesion Treatment Outcomes
A Phase 3 study of Noncarious Cervical Lesions, sponsored by Pearl Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
- 17
- Study locations
NCT00867997 is a Phase 3 study of Noncarious Cervical Lesions that has completed, run by Pearl Network. The registered enrollment target is 304 participants. The trial reports 17 study locations across 7 states.
The verdict
NCT00867997, a Phase 3 study of Noncarious Cervical Lesions, has completed, sponsored by Pearl Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
- 17
- Study locations
Study 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 reduction/elimination 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.
Conditions Studied
Interventions
- OTHER Chemoactive (remineralizing, neuroactive) dentifrice treatment
- OTHER Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F
- OTHER Clearfil S3 Bond; Premise Flowable resin-based composite
Study Locations (17)
New Jersey
- Scott B Schaffer, DMD - Clark
- Gentle Dental Care, LLC - Edison
- Dr. Howard Spielman - Plainsboro
- Drs. Martin & Ferraiolo - Totowa
- Cynthia Jetter, DMD - Voorhees Township
New York
- Bay Dental PC - Brooklyn
- Ying Wong, DDS - New York
- Martin Man, DMD - New York
- Kay T. Oen, DDS - Port Chester
- Janice K. Pliszczak, DDS - Syracuse
Pennsylvania
- Dr. Jeannette Abboud-Niemczyk - Drexel Hill
- Allan J Horowitz, DMD - King of Prussia
- Dr. Julie Ann Barna - Lewisburg
Connecticut
- Maryann Lehmann, DDS - Darien
Maryland
- Ahmad Soolari, D.M.D. - Potomac
Massachusetts
- Oral Health Center - Southborough
Ohio
- Susan D. Bernstein, DDS - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2009-03 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00867997
The ClinicalTrials.gov registry entry for NCT00867997 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pearl Network, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Noncarious Cervical Lesions appearing as the primary indexed condition, and to 3 interventions - of which Chemoactive (remineralizing, neuroactive) dentifrice treatment is the first listed.
NCT00867997 reports 17 study locations spanning 7 distinct geographic areas - top geographies include New Jersey, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00867997 about?
NCT00867997 is a clinical study titled "Noncarious Cervical Lesion Treatment Outcomes". 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 restor...
What is the current status of trial NCT00867997?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2009-03. Estimated completion is 2012-02.
What conditions does trial NCT00867997 study?
This clinical trial studies the following conditions: Noncarious Cervical Lesions.
What interventions are being tested in trial NCT00867997?
The interventions under investigation include: Chemoactive (remineralizing, neuroactive) dentifrice treatment (OTHER), Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F (OTHER), Clearfil S3 Bond; Premise Flowable resin-based composite (OTHER).
Who is sponsoring clinical trial NCT00867997?
This trial is sponsored by Pearl Network, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00867997 being conducted?
This trial has 17 study locations across Connecticut, Maryland, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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