Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial

NCT01268605 | Completed Phase 3 DMC

• 3 other identifiers: PRL1013U01DE016755136277
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 41

Brief 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.

Conditions

Dental Caries

Keywords

Dental caries; Resin based composite; Hypersensitivity; Teeth; Dentistry; Practice-based research network

Outcome Measures

Primary Outcomes (1)

• Hypersensitivity

  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.

  4 weeks

Secondary Outcomes (5)

• Preoperative caries stage

  Baseline

• Lesion depth

  Baseline

• Dentin caries activity

  Baseline

• Preparation depth

  Baseline

• Sleep bruxism status

  Baseline

Study Arms (2)

Restoration with a dentin bonding agent (DBA)

ACTIVE COMPARATOR

Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions.

Procedure: Restoration with a dentin bonding agent (DBA)

Restoration with a resin modified glass ionomer liner (RMGI)

ACTIVE COMPARATOR

Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC).

Procedure: Restoration with a resin modified glass ionomer liner (RMGI)

Interventions

Restoration with a dentin bonding agent (DBA) PROCEDURE

Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions.

Restoration with a dentin bonding agent (DBA)

Restoration with a resin modified glass ionomer liner (RMGI) PROCEDURE

Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC).

Restoration with a resin modified glass ionomer liner (RMGI)

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Presence of solely adult dentition ages 15 to 60 (The upper age of 60 years is selected since the pulp space is limited and POH is less likely above this age).
• Lesion depth, if visible on radiograph, must be ≤1/2 the distance from the Dento-Enamel Junction (DEJ) to the pulp and the radiograph cannot be more than 9 months old.
• The tooth must be in occlusion with a natural tooth.
• A resin-based composite restoration would be the standard of care for the lesion.
• The tooth must be free of evidence of a pulpitis (no report of lingering pain associated with any stimulus).
• Subjects must be available for contact for at least four weeks post-treatment.
• Subjects willing and able to understand and sign the IRB-approved informed consent form and for individuals under the age of 18, the parental / guardian assent form.
• Subject's baseline score on the NPAS must be ≥3 for air and/or cold stimulation but not exhibit pain lasting more than approximately four seconds which is known as "lingering pain"
• Gingival Index of less than or equal to 2.

You may not qualify if:

• Individuals in which the second molars are not fully erupted.
• Teeth with a mobility of 2 or greater, or inflamed gingival tissues.
• Existing restoration(s) on the same tooth.
• Teeth that have been clinically assessed to be fractured.
• Tooth is an abutment for a removable partial denture.
• Tooth with subgingival calculus, unless removed during the treatment visit.
• Subjects undergoing active orthodontic treatment. Use of retainers is allowed.
• Subjects currently enrolled in or who have completed in the past month a tooth bleaching program.
• Subjects with prior reaction or inability to tolerate any of the dental products being used, such as severe topical or hypersensitivity reaction.
• Subjects under treatment for medical disorders including: dementia, Parkinson's disease, severe depression, severe anxiety, and any other medical condition that, in the opinion of the P-I, would affect the subject's judgment of postoperative hypersensitivity and ability to understand the informed consent process.
• Subjects in another ongoing dental research study.

Sponsors & Collaborators

• Pearl Network: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (41)

Phoenix Pediatric Dental

Phoeniz, Arizona, 85015, United States

Location

Watson and Niven Dental Partnership

Newport Beach, California, 92660, United States

Location

Jana A. Ikeda, DDS, PC

Boulder, Colorado, 80305, United States

Location

Maryann Lehmann, D.D.S.

Darien, Connecticut, 06820, United States

Location

Oracare Research

Sanford, Florida, 32771, United States

Location

Complete Dental Arts, P.C.

Newnan, Georgia, 30265, United States

Location

Creative Smiles Dental Care

Champaign, Illinois, 61820, United States

Location

Peggy Richardson, DDS, MS

Tinley Park, Illinois, 60477, United States

Location

Kokomo Oral Implantology

Kokomo, Indiana, 46901, United States

Location

Corridor Kids Pediatric Dentistry

North Liberty, Iowa, 52317, United States

Location

Community Dental - Biddeford Center

Biddeford, Maine, 04005, United States

Location

Cheryl F, Callahan, DDS, PA

Rockville, Maryland, 20850, United States

Location

Oral Medicine - Tufts School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Frank A Dahlstrom,DMD,PC

Dennis, Massachusetts, 02638, United States

Location

Oral Health Center

Southborough, Massachusetts, 01772, United States

Location

Small Smiles Dental Center of Springfield, LLC

Springfield, Massachusetts, 01128, United States

Location

Keith A Hudson DDS PC

Franklin, Michigan, 48025, United States

Location

Minnesota Dentalcare

Richfield, Minnesota, 55423, United States

Location

Eric Hirschfeld, D.D.S.

Conway, New Hampshire, 03818, United States

Location

Bordentown Family Dental

Bordentown, New Jersey, 08505, United States

Location

Scott B Schaffer, DMD

Clark, New Jersey, 07066, United States

Location

Gentle Dental Care, LLC

Edison, New Jersey, 08820, United States

Location

Dr. Howard Spielman

Plainsboro, New Jersey, 08536, United States

Location

Barry G. Dale, DMD

Tenafly, New Jersey, 07670, United States

Location

Cynthia Jetter, DMD

Voorhees Township, New Jersey, 08043, United States

Location

Bay Dental PC

Brooklyn, New York, 11229, United States

Location

Eric Leibowitz DDS

Brooklyn, New York, 11230, United States

Location

Queens Comprehensive Dental Services

Forest Hills, New York, 11375, United States

Location

Gilberto Nunez DDS LLC

Kingston, New York, 12401, United States

Location

Kay T. Oen, DDS

Port Chester, New York, 10573, United States

Location

East Avenue Dentistry PLLC

Rochester, New York, 14610, United States

Location

James R. Keenan, DDS, PC

Rockaway Beach, New York, 11693, United States

Location

Janice K. Pliszczak, DDS

Syracuse, New York, 13215, United States

Location

Susan D. Bernstein, DDS

Cincinnati, Ohio, 45231, United States

Location

Laurence H Stone, DDS

Doylestown, Pennsylvania, 18902, United States

Location

Dr. Jeannette Abboud-Niemczyk

Drexel Hill, Pennsylvania, 19026, United States

Location

Allan J Horowitz, DMD

King of Prussia, Pennsylvania, 19406, United States

Location

Dr. Julie Ann Barna

Lewisburg, Pennsylvania, 17837, United States

Location

Salvation Army Dental Center

Oil City, Pennsylvania, 16301, United States

Location

Elizabeth W. Galloway

Hilton Head Island, South Carolina, 29928, United States

Location

MEHOP

Bay City, Texas, 77414, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Dental Caries; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Officials

• Frederick A Curro, DMD, Phd

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: December 31, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

US (41)