Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
Public ClinicalTrials.gov record NCT01268605. 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
Resin Based Composite Occlusal Restoration Postoperative Hypersensitivity: Randomized Comparative Effectiveness Research Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01268605
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 341 participants
Conditions and interventions
Conditions
Interventions
- Restoration with a dentin bonding agent (DBA) Procedure
- Restoration with a resin modified glass ionomer liner (RMGI) Procedure
Procedure
Eligibility (public fields only)
- Age range
- 15 Years to 60 Years
- 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
- Sep 2010 (Type not available)
- Primary completion
- Apr 2012 (Actual)
- Completion
- Apr 2012 (Actual)
- Last update posted
- Sep 19, 2014
2010 – 2012
United States locations
- U.S. sites
- 41
- U.S. states
- 21
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Pediatric Dental | Phoeniz | Arizona | 85015 | — |
| Watson and Niven Dental Partnership | Newport Beach | California | 92660 | — |
| Jana A. Ikeda, DDS, PC | Boulder | Colorado | 80305 | — |
| Maryann Lehmann, D.D.S. | Darien | Connecticut | 06820 | — |
| Oracare Research | Sanford | Florida | 32771 | — |
| Complete Dental Arts, P.C. | Newnan | Georgia | 30265 | — |
| Creative Smiles Dental Care | Champaign | Illinois | 61820 | — |
| Peggy Richardson, DDS, MS | Tinley Park | Illinois | 60477 | — |
| Kokomo Oral Implantology | Kokomo | Indiana | 46901 | — |
| Corridor Kids Pediatric Dentistry | North Liberty | Iowa | 52317 | — |
| Community Dental - Biddeford Center | Biddeford | Maine | 04005 | — |
| Cheryl F, Callahan, DDS, PA | Rockville | Maryland | 20850 | — |
| Oral Medicine - Tufts School of Dental Medicine | Boston | Massachusetts | 02111 | — |
| Frank A Dahlstrom,DMD,PC | Dennis | Massachusetts | 02638 | — |
| Oral Health Center | Southborough | Massachusetts | 01772 | — |
| Small Smiles Dental Center of Springfield, LLC | Springfield | Massachusetts | 01128 | — |
| Keith A Hudson DDS PC | Franklin | Michigan | 48025 | — |
| Minnesota Dentalcare | Richfield | Minnesota | 55423 | — |
| Eric Hirschfeld, D.D.S. | Conway | New Hampshire | 03818 | — |
| Bordentown Family Dental | Bordentown | New Jersey | 08505 | — |
| Scott B Schaffer, DMD | Clark | New Jersey | 07066 | — |
| Gentle Dental Care, LLC | Edison | New Jersey | 08820 | — |
| Dr. Howard Spielman | Plainsboro | New Jersey | 08536 | — |
| Barry G. Dale, DMD | Tenafly | New Jersey | 07670 | — |
| Cynthia Jetter, DMD | Voorhees Township | New Jersey | 08043 | — |
| Bay Dental PC | Brooklyn | New York | 11229 | — |
| Eric Leibowitz DDS | Brooklyn | New York | 11230 | — |
| Queens Comprehensive Dental Services | Forest Hills | New York | 11375 | — |
| Gilberto Nunez DDS LLC | Kingston | New York | 12401 | — |
| Kay T. Oen, DDS | Port Chester | New York | 10573 | — |
| East Avenue Dentistry PLLC | Rochester | New York | 14610 | — |
| James R. Keenan, DDS, PC | Rockaway Beach | New York | 11693 | — |
| Janice K. Pliszczak, DDS | Syracuse | New York | 13215 | — |
| Susan D. Bernstein, DDS | Cincinnati | Ohio | 45231 | — |
| Laurence H Stone, DDS | Doylestown | Pennsylvania | 18902 | — |
| Dr. Jeannette Abboud-Niemczyk | Drexel Hill | Pennsylvania | 19026 | — |
| Allan J Horowitz, DMD | King of Prussia | Pennsylvania | 19406 | — |
| Dr. Julie Ann Barna | Lewisburg | Pennsylvania | 17837 | — |
| Salvation Army Dental Center | Oil City | Pennsylvania | 16301 | — |
| Elizabeth W. Galloway | Hilton Head Island | South Carolina | 29928 | — |
| MEHOP | Bay City | Texas | 77414 | — |
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 NCT01268605, 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 Sep 19, 2014 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01268605 live on ClinicalTrials.gov.