Clinical trial NCT01268605: Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial
Official title: Resin Based Composite Occlusal Restoration Postoperative Hypersensitivity: Randomized Comparative Effectiveness Research Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Keywords: Dental caries
Resin based composite
Hypersensitivity
Teeth
Dentistry
Practice-based research network
Lead sponsor: Pearl Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2010-12-31
Enrollment: 341
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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).
2. Presence of one or more permanent posterior teeth (in different quadrants, with third molars excluded) with the clinical diagnosis of new Class I caries extending into dentin with or without radiographic confirmation. Up to 4 teeth (one per quadrant) may be enrolled. If there is more than one occlusal lesion in a quadrant that meets the inclusion criteria the patient is not eligible for inclusion in the study. Only one tooth per quadrant can be treated during the 4 weeks of this study.
3. 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.
4. The tooth must be in occlusion with a natural tooth.
5. A resin-based composite restoration would be the standard of care for the lesion.
6. The tooth must be free of evidence of a pulpitis (no report of lingering pain associated with any stimulus).
7. Subjects must be available for contact for at least four weeks post-treatment.
8. 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.
9. 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"
10. Gingival Index of less than or equal to 2.

Exclusion Criteria:

1. Individuals in which the second molars are not fully erupted.
2. Teeth with a mobility of 2 or greater, or inflamed gingival tissues.
3. Existing restoration(s) on the same tooth.
4. Teeth that have been clinically assessed to be fractured.
5. Tooth is an abutment for a removable partial denture.
6. Tooth with subgingival calculus, unless removed during the treatment visit.
7. Subjects undergoing active orthodontic treatment. Use of retainers is allowed.
8. Subjects currently enrolled in or who have completed in the past month a tooth bleaching program.
9. Subjects with prior reaction or inability to tolerate any of the dental products being used, such as severe topical or hypersensitivity reaction.
10. 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.
11. Subjects in another ongoing dental research study.

Primary outcomes:
measure: Hypersensitivity
timeFrame: 4 weeks
Secondary outcomes:
measure: Preoperative caries stage
timeFrame: Baseline
measure: Lesion depth
timeFrame: Baseline
measure: Dentin caries activity
timeFrame: Baseline
measure: Preparation depth
timeFrame: Baseline
measure: Sleep bruxism status
timeFrame: Baseline
Other outcomes:
Locations:
city: Phoeniz
country: United States
facility: Phoenix Pediatric Dental
state: Arizona
city: Newport Beach
country: United States
facility: Watson and Niven Dental Partnership
state: California
city: Boulder
country: United States
facility: Jana A. Ikeda, DDS, PC
state: Colorado
city: Darien
country: United States
facility: Maryann Lehmann, D.D.S.
state: Connecticut
city: Sanford
country: United States
facility: Oracare Research
state: Florida
city: Newnan
country: United States
facility: Complete Dental Arts, P.C.
state: Georgia
city: Champaign
country: United States
facility: Creative Smiles Dental Care
state: Illinois
city: Tinley Park
country: United States
facility: Peggy Richardson, DDS, MS
state: Illinois
city: Kokomo
country: United States
facility: Kokomo Oral Implantology
state: Indiana
city: North Liberty
country: United States
facility: Corridor Kids Pediatric Dentistry
state: Iowa
city: Biddeford
country: United States
facility: Community Dental - Biddeford Center
state: Maine
city: Rockville
country: United States
facility: Cheryl F, Callahan, DDS, PA
state: Maryland
city: Boston
country: United States
facility: Oral Medicine - Tufts School of Dental Medicine
state: Massachusetts
city: Dennis
country: United States
facility: Frank A Dahlstrom,DMD,PC
state: Massachusetts
city: Southborough
country: United States
facility: Oral Health Center
state: Massachusetts
city: Springfield
country: United States
facility: Small Smiles Dental Center of Springfield, LLC
state: Massachusetts
city: Franklin
country: United States
facility: Keith A Hudson DDS PC
state: Michigan
city: Richfield
country: United States
facility: Minnesota Dentalcare
state: Minnesota
city: Conway
country: United States
facility: Eric Hirschfeld, D.D.S.
state: New Hampshire
city: Bordentown
country: United States
facility: Bordentown Family Dental
state: New Jersey
city: Clark
country: United States
facility: Scott B Schaffer, DMD
state: New Jersey
city: Edison
country: United States
facility: Gentle Dental Care, LLC
state: New Jersey
city: Plainsboro
country: United States
facility: Dr. Howard Spielman
state: New Jersey
city: Tenafly
country: United States
facility: Barry G. Dale, DMD
state: New Jersey
city: Voorhees
country: United States
facility: Cynthia Jetter, DMD
state: New Jersey
city: Brooklyn
country: United States
facility: Bay Dental PC
state: New York
city: Brooklyn
country: United States
facility: Eric Leibowitz DDS
state: New York
city: Forest Hills
country: United States
facility: Queens Comprehensive Dental Services
state: New York
city: Kingston
country: United States
facility: Gilberto Nunez DDS LLC
state: New York
city: Port Chester
country: United States
facility: Kay T. Oen, DDS
state: New York
city: Rochester
country: United States
facility: East Avenue Dentistry PLLC
state: New York
city: Rockaway Beach
country: United States
facility: James R. Keenan, DDS, PC
state: New York
city: Syracuse
country: United States
facility: Janice K. Pliszczak, DDS
state: New York
city: Cincinnati
country: United States
facility: Susan D. Bernstein, DDS
state: Ohio
city: Doylestown
country: United States
facility: Laurence H Stone, DDS
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Dr. Jeannette Abboud-Niemczyk
state: Pennsylvania
city: King of Prussia
country: United States
facility: Allan J Horowitz, DMD
state: Pennsylvania
city: Lewisburg
country: United States
facility: Dr. Julie Ann Barna
state: Pennsylvania
city: Oil City
country: United States
facility: Salvation Army Dental Center
state: Pennsylvania
city: Hilton Head Island
country: United States
facility: Elizabeth W. Galloway
state: South Carolina
city: Bay City
country: United States
facility: MEHOP
state: Texas
Study officials:
affiliation: NYU Langone Health
name: Frederick A Curro, DMD, Phd
role: PRINCIPAL_INVESTIGATOR
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