Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2009-03-31
2012-02-29
Brief Summary
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Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups.
Specific Aim 2: To recruit subjects with teeth with hypersensitive NCLs, measure baseline sensitivity and subject quality of life, administer one of three different treatments to each of three randomized groups of subjects, and determine immediate posttreatment hypersensitivity.
Specific Aim 3: To compare the degree of tubule occlusion before and after the three treatments and to associate these findings with posttreatment hypersensitivity, patient-reported outcomes, and restoration retention.
Treatment of NCLs remains controversial. Few studies have compared treatment methods or their financial implications. This RCT will determine the reduction of NCL hypersensitivity and patient-reported outcomes over a 6-month period for each of three different treatments. This will be the first practice-based research network RCT to combine objective clinical assessment of NCL treatment patient-reported outcomes with laboratory examination of dentin tubule occlusion and lesion size.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dentifrice
Chemoactive (remineralizing, neuroactive) dentifrice treatment
Chemoactive (remineralizing, neuroactive) dentifrice treatment
Chemoactive (remineralizing, neuroactive) dentifrice treatment
Sealant
DBA/sealant application
Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F
Self-etch DBA followed by a hydrophobic resin layer
Resin-based composite
Restoration with a dentin bonding agent (DBA) and flowable resin-based composite
Clearfil S3 Bond; Premise Flowable resin-based composite
Restoration with a dentin bonding agent (DBA) and flowable resin-based composite
Interventions
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Chemoactive (remineralizing, neuroactive) dentifrice treatment
Chemoactive (remineralizing, neuroactive) dentifrice treatment
Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F
Self-etch DBA followed by a hydrophobic resin layer
Clearfil S3 Bond; Premise Flowable resin-based composite
Restoration with a dentin bonding agent (DBA) and flowable resin-based composite
Eligibility Criteria
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Inclusion Criteria
* Teeth with NCL depth of at least 1 mm as measured by placing a periodontal probe (e.g.) into the deepest part of the cervical lesion
* Teeth free of mesial, distal, or buccal restorations (to avoid confounding hypersensitivity)
* Teeth with mobility of \<1 mm when manipulated between blunt instruments
* Subject able to follow the study protocol and willing to return for all evaluation appointments
* Subject able to comprehend and sign the written consent form
* Subject 18 years of age or older
Exclusion Criteria
* Subject who is taking a medication that could interfere with reliable pain reporting
* Subject who has taken an analgesic medication (narcotic, NSAID, acetaminophen, salicylic acid) within 24 hr pretreatment
* Subject who is undergoing active orthodontic treatment
* Subject with any of the following: a) Hypersensitive teeth with carious lesions; b) Hypersensitive teeth with buccal vertical cracks in enamel; c) Hypersensitive teeth with an irreversible pulpitis (pain lasting more than 5 sec after stimulation); d) Hypersensitive teeth with full crowns; e) Hypersensitive teeth with partial denture clasps on the facial surface; f) Evidence of inflamed gingival tissue and bleeding on probing in the sextant being considered for treatment as part of the study (the etiology of these lesion is closely related to excessive or improper brushing perhaps with an abrasive dentifrice and there is almost never accumulated plaque associated with the NCL)
18 Years
ALL
No
Sponsors
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National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Pearl Network
NETWORK
Responsible Party
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Principal Investigators
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Frederick A Curro, DMD, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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Maryann Lehmann, DDS
Darien, Connecticut, United States
Ahmad Soolari, D.M.D.
Potomac, Maryland, United States
Oral Health Center
Southborough, Massachusetts, United States
Scott B Schaffer, DMD
Clark, New Jersey, United States
Gentle Dental Care, LLC
Edison, New Jersey, United States
Dr. Howard Spielman
Plainsboro, New Jersey, United States
Drs. Martin & Ferraiolo
Totowa, New Jersey, United States
Cynthia Jetter, DMD
Voorhees Township, New Jersey, United States
Bay Dental PC
Brooklyn, New York, United States
Ying Wong, DDS
New York, New York, United States
Martin Man, DMD
New York, New York, United States
Kay T. Oen, DDS
Port Chester, New York, United States
Janice K. Pliszczak, DDS
Syracuse, New York, United States
Susan D. Bernstein, DDS
Cincinnati, Ohio, United States
Dr. Jeannette Abboud-Niemczyk
Drexel Hill, Pennsylvania, United States
Allan J Horowitz, DMD
King of Prussia, Pennsylvania, United States
Dr. Julie Ann Barna
Lewisburg, Pennsylvania, United States
Countries
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References
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Bartlett DW, Shah P. A critical review of non-carious cervical (wear) lesions and the role of abfraction, erosion, and abrasion. J Dent Res. 2006 Apr;85(4):306-12. doi: 10.1177/154405910608500405.
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Ceruti P, Menicucci G, Mariani GD, Pittoni D, Gassino G. Non carious cervical lesions. A review. Minerva Stomatol. 2006 Jan-Feb;55(1-2):43-57. English, Italian.
Duran I, Sengun A. The long-term effectiveness of five current desensitizing products on cervical dentine sensitivity. J Oral Rehabil. 2004 Apr;31(4):351-6. doi: 10.1046/j.1365-2842.2003.01241.x.
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Other Identifiers
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116358
Identifier Type: -
Identifier Source: secondary_id
PRL0707
Identifier Type: -
Identifier Source: org_study_id