Noncarious Cervical Lesion Treatment Outcomes
Public ClinicalTrials.gov record NCT00867997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Noncarious Cervical Lesion Treatment Outcomes: Randomized Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00867997
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 304 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2009
- Primary completion
- Jun 30, 2011
- Completion
- Jan 31, 2012
- Last update posted
- Feb 28, 2012
2009 – 2012
United States locations
- U.S. sites
- 17
- U.S. states
- 7
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maryann Lehmann, DDS | Darien | Connecticut | 06820 | — |
| Ahmad Soolari, D.M.D. | Potomac | Maryland | 20854 | — |
| Oral Health Center | Southborough | Massachusetts | 01772 | — |
| Scott B Schaffer, DMD | Clark | New Jersey | 07066 | — |
| Gentle Dental Care, LLC | Edison | New Jersey | 08820 | — |
| Dr. Howard Spielman | Plainsboro | New Jersey | 08536 | — |
| Drs. Martin & Ferraiolo | Totowa | New Jersey | 07512 | — |
| Cynthia Jetter, DMD | Voorhees Township | New Jersey | 08043 | — |
| Bay Dental PC | Brooklyn | New York | 11229 | — |
| Ying Wong, DDS | New York | New York | 10024 | — |
| Martin Man, DMD | New York | New York | 10038 | — |
| Kay T. Oen, DDS | Port Chester | New York | 10573 | — |
| Janice K. Pliszczak, DDS | Syracuse | New York | 13215 | — |
| Susan D. Bernstein, DDS | Cincinnati | Ohio | 45231 | — |
| Dr. Jeannette Abboud-Niemczyk | Drexel Hill | Pennsylvania | 19026 | — |
| Allan J Horowitz, DMD | King of Prussia | Pennsylvania | 19406 | — |
| Dr. Julie Ann Barna | Lewisburg | Pennsylvania | 17837 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00867997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 28, 2012 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00867997 live on ClinicalTrials.gov.