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Dental CariesPhase 3POH RCERTNCT01268605

Postoperative Hypersensitivity Randomized Comparative Effectiveness Research Trial

A Phase 3 study testing Restoration with a dentin bonding agent (DBA) and Restoration with a resin modified glass ionomer liner (RMGI) in people with Dental Caries, run by Pearl Network at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 to 60 years
Conditions the study is for
Dental Caries
What is being tested?
Restoration with a dentin bonding agent (DBA) and Restoration with a resin modified glass ionomer liner (RMGI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
341 participants
Where
41 sitesUnited States
Study dates
Sep 2010to Apr 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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).
  • 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.
  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • MEHOP

    Bay City, Texas, 77414

  • Community Dental - Biddeford Center

    Biddeford, Maine, 04005

  • Bordentown Family Dental

    Bordentown, New Jersey, 08505

  • Oral Medicine - Tufts School of Dental Medicine

    Boston, Massachusetts, 02111

  • Jana A. Ikeda, DDS, PC

    Boulder, Colorado, 80305

  • Bay Dental PC

    Brooklyn, New York, 11229

  • Eric Leibowitz DDS

    Brooklyn, New York, 11230

  • Creative Smiles Dental Care

    Champaign, Illinois, 61820

  • Susan D. Bernstein, DDS

    Cincinnati, Ohio, 45231

  • Scott B Schaffer, DMD

    Clark, New Jersey, 07066

  • Eric Hirschfeld, D.D.S.

    Conway, New Hampshire, 03818

  • Maryann Lehmann, D.D.S.

    Darien, Connecticut, 06820

  • Frank A Dahlstrom,DMD,PC

    Dennis, Massachusetts, 02638

  • Laurence H Stone, DDS

    Doylestown, Pennsylvania, 18902

  • Dr. Jeannette Abboud-Niemczyk

    Drexel Hill, Pennsylvania, 19026

  • Gentle Dental Care, LLC

    Edison, New Jersey, 08820

  • Queens Comprehensive Dental Services

    Forest Hills, New York, 11375

  • Keith A Hudson DDS PC

    Franklin, Michigan, 48025

  • Elizabeth W. Galloway

    Hilton Head Island, South Carolina, 29928

  • Allan J Horowitz, DMD

    King of Prussia, Pennsylvania, 19406

  • Gilberto Nunez DDS LLC

    Kingston, New York, 12401

  • Kokomo Oral Implantology

    Kokomo, Indiana, 46901

  • Dr. Julie Ann Barna

    Lewisburg, Pennsylvania, 17837

  • Complete Dental Arts, P.C.

    Newnan, Georgia, 30265

  • Watson and Niven Dental Partnership

    Newport Beach, California, 92660

  • Corridor Kids Pediatric Dentistry

    North Liberty, Iowa, 52317

  • Salvation Army Dental Center

    Oil City, Pennsylvania, 16301

  • Phoenix Pediatric Dental

    Phoeniz, Arizona, 85015

  • Dr. Howard Spielman

    Plainsboro, New Jersey, 08536

  • Kay T. Oen, DDS

    Port Chester, New York, 10573

  • Minnesota Dentalcare

    Richfield, Minnesota, 55423

  • East Avenue Dentistry PLLC

    Rochester, New York, 14610

  • James R. Keenan, DDS, PC

    Rockaway Beach, New York, 11693

  • Cheryl F, Callahan, DDS, PA

    Rockville, Maryland, 20850

  • Oracare Research

    Sanford, Florida, 32771

  • Oral Health Center

    Southborough, Massachusetts, 01772

  • Small Smiles Dental Center of Springfield, LLC

    Springfield, Massachusetts, 01128

  • Janice K. Pliszczak, DDS

    Syracuse, New York, 13215

  • Barry G. Dale, DMD

    Tenafly, New Jersey, 07670

  • Peggy Richardson, DDS, MS

    Tinley Park, Illinois, 60477

  • Cynthia Jetter, DMD

    Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

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

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.

Read more

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
Being tested
Restoration with a dentin bonding agent (DBA), Restoration with a resin modified glass ionomer liner (RMGI)
Keywords
Dental caries, Resin based composite, Hypersensitivity, Teeth, Dentistry, Practice-based research network
Medical subject headings
Dental Caries, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Restoration with a dentin bonding agent (DBA)Procedure or surgery

    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)Procedure or surgery

    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).

Study groups in NCT01268605
Study groupRoleWhat they receive
Restoration with a dentin bonding agent (DBA)Active comparatorRestoration 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.
Receives: Procedure: Restoration with a dentin bonding agent (DBA)
Restoration with a resin modified glass ionomer liner (RMGI)Active comparatorRestoration 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).
Receives: Procedure: Restoration with a resin modified glass ionomer liner (RMGI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01268605
Sponsor's protocol ID
PRL1013
Other IDs
U01DE016755, 136277
Acronym
POH RCERT
Status last verified
Sep 2014
First submitted
19 Oct 2010
Last updated
19 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • American Academy of Sleep Medicine (2001). The international classification of sleep disorders, revised: diagnosis and coding manual. Westchester, IL: American Academy of Sleep Medicine.

  • 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.

    PubMed 11806478

  • Akpata ES, Behbehani J. Effect of bonding systems on post-operative sensitivity from posterior composites. Am J Dent. 2006 Jun;19(3):151-4.

    PubMed 16838478

  • Auschill TM, Koch CA, Wolkewitz M, Hellwig E, Arweiler NB. Occurrence and causing stimuli of postoperative sensitivity in composite restorations. Oper Dent. 2009 Jan-Feb;34(1):3-10. doi: 10.2341/08-7.

    PubMed 19192831

  • 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. doi: 10.1111/j.1708-8240.2001.tb00251.x.

    PubMed 11831309

  • Briso AL, Mestrener SR, Delicio 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. doi: 10.2341/06-141.

    PubMed 17910217

  • Browning WD, Blalock JS, Callan RS, Brackett WW, Schull GF, Davenport MB, Brackett MG. Postoperative sensitivity: a comparison of two bonding agents. Oper Dent. 2007 Mar-Apr;32(2):112-7. doi: 10.2341/06-58.

    PubMed 17427818

  • Casselli DS, Martins LR. Postoperative sensitivity in Class I composite resin restorations in vivo. J Adhes Dent. 2006 Feb;8(1):53-8.

    PubMed 16536346

  • Cho BH, Dickens SH, Bae JH, Chang CG, Son HH, Um CM. Effect of interfacial bond quality on the direction of polymerization shrinkage flow in resin composite restorations. Oper Dent. 2002 May-Jun;27(3):297-304.

    PubMed 12022463

  • Christensen GJ. Preventing postoperative tooth sensitivity in class I, II and V restorations. J Am Dent Assoc. 2002 Feb;133(2):229-31. doi: 10.14219/jada.archive.2002.0149.

    PubMed 11868844

  • Efes BG, Dorter C, Gomec Y, Koray F. Two-year clinical evaluation of ormocer and nanofill composite with and without a flowable liner. J Adhes Dent. 2006 Apr;8(2):119-26.

    PubMed 16708724

  • Ernst CP, Martin M, Stuff S, Willershausen B. Clinical performance of a packable resin composite for posterior teeth after 3 years. Clin Oral Investig. 2001 Sep;5(3):148-55. doi: 10.1007/s007840100117.

    PubMed 11642558

  • Ernst CP, Brandenbusch M, Meyer G, Canbek K, Gottschalk F, Willershausen B. Two-year clinical performance of a nanofiller vs a fine-particle hybrid resin composite. Clin Oral Investig. 2006 Jun;10(2):119-25. doi: 10.1007/s00784-006-0041-8. Epub 2006 Mar 23.

    PubMed 16555069

  • Gordan VV, Mjor IA. Short- and long-term clinical evaluation of post-operative sensitivity of a new resin-based restorative material and self-etching primer. Oper Dent. 2002 Nov-Dec;27(6):543-8.

    PubMed 12413217

  • Hayashi M, Wilson NH. Failure risk of posterior composites with post-operative sensitivity. Oper Dent. 2003 Nov-Dec;28(6):681-8.

    PubMed 14653280

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Restoration with a dentin bonding agent (DBA) and Restoration with a resin modified glass ionomer liner (RMGI) in people with Dental Caries, run by Pearl Network at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypersensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01268605, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.

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