Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial

Dental Caries Clinical Trial

— POH RCERT  

Official title:

Resin Based Composite Occlusal Restoration Postoperative Hypersensitivity: Randomized Comparative Effectiveness Research Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268605
• Other study ID #: PRL1013
• Secondary ID: U01DE01675513627
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2010
• Last updated: September 18, 2014
• Start date: September 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2014
• Source: Pearl Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries
• Hypersensitivity

Intervention

Procedure:
• Restoration with a dentin bonding agent (DBA)
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 resin modified glass ionomer liner (RMGI)
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).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Pearl Network	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (37)

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Akpata ES, Sadiq W. Post-operative sensitivity in glass-ionomer versus adhesive resin-lined posterior composites. Am J Dent. 2001 Feb;14(1):34-8. — View Citation

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Baratieri LN, Ritter AV. Four-year clinical evaluation of posterior resin-based composite restorations placed using the total-etch technique. J Esthet Restor Dent. 2001;13(1):50-7. — View Citation

Briso AL, Mestrener SR, Delício G, Sundfeld RH, Bedran-Russo AK, de Alexandre RS, Ambrosano GM. Clinical assessment of postoperative sensitivity in posterior composite restorations. Oper Dent. 2007 Sep-Oct;32(5):421-6. — View Citation

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Preoperative caries stage	To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.	Baseline	No
Secondary	Lesion depth	To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.	Baseline	No
Secondary	Dentin caries activity	To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.	Baseline	No
Secondary	Preparation depth	To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.	Baseline	No
Secondary	Sleep bruxism status	To identify putative risk factors for POH (or factors associated with differences in POH) including: preoperative caries stage measured by the proposed 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.	Baseline	No

External Links

•   PEARL Network website