Noncarious Cervical Lesion Treatment Outcomes

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pearl Network
ClinicalTrials.gov Identifier:
NCT00867997
First received: March 23, 2009
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

The overall objective of this three-armed randomized clinical trial (RCT) is to determine the comparative efficacy of three treatments for hypersensitive noncarious cervical lesions (NCLs): chemoactive dentifrice use, dentin bonding agent (DBA) with sealing, and flowable resin-based composite restoration. The primary outcomes of this study are the reduction/elimination of hypersensitivity and the effect of treatment as measured by patient-reported outcomes. Secondary outcomes, as determined by laboratory evaluation of intraoral replicas of pre- and posttreatment NCL surfaces, are tubule occlusion, retention of resin coating, retention of restoration, and change in lesion size. Outcomes will be ascertained via the following specific aims:

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.


Condition Intervention Phase
Noncarious Cervical Lesions
Other: Chemoactive (remineralizing, neuroactive) dentifrice treatment
Other: Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F
Other: Clearfil S3 Bond; Premise Flowable resin-based composite
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Noncarious Cervical Lesion Treatment Outcomes: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Pearl Network:

Primary Outcome Measures:
  • To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups. [ Time Frame: Baseline, 1, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Baseline, 1, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 304
Study Start Date: March 2009
Study Completion Date: February 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dentifrice
Chemoactive (remineralizing, neuroactive) dentifrice treatment
Other: Chemoactive (remineralizing, neuroactive) dentifrice treatment
Chemoactive (remineralizing, neuroactive) dentifrice treatment
Active Comparator: Sealant
DBA/sealant application
Other: Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F
Self-etch DBA followed by a hydrophobic resin layer
Active Comparator: Resin-based composite
Restoration with a dentin bonding agent (DBA) and flowable resin-based composite
Other: Clearfil S3 Bond; Premise Flowable resin-based composite
Restoration with a dentin bonding agent (DBA) and flowable resin-based composite

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A premolar or first molar with an NCL and hypersensitivity of ≥3 as indicated by the subject on the Numeric Pain Assessment Scale (2008 NCCN) with standardized air blast stimulation with no other tooth exhibiting hypersensitivity (≥2 as indicated by the subject on the NPAS) in the same quadrant. If the patient has a tooth in more than one quadrant that meet these criteria then the quadrant selected will be that containing the tooth with the highest hypersensitivity reading. If the sensitivities are the same the quadrant with the lesion with the greatest depth would be selected. If the sensitivities and depth are the same the quadrant with the most convenient restorative access will be selected.
  • 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 has a medical condition that could interfere with reliable pain reporting
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867997

Locations
United States, Connecticut
Maryann Lehmann, DDS
Darien, Connecticut, United States, 06820
United States, Maryland
Ahmad Soolari, D.M.D.
Potomac, Maryland, United States, 20854
United States, Massachusetts
Oral Health Center
Southborough, Massachusetts, United States, 01772
United States, New Jersey
Scott B Schaffer, DMD
Clark, New Jersey, United States, 07066
Gentle Dental Care, LLC
Edison, New Jersey, United States, 08820
Dr. Howard Spielman
Plainsboro, New Jersey, United States, 08536
Drs. Martin & Ferraiolo
Totowa, New Jersey, United States, 07512
Cynthia Jetter, DMD
Voorhees, New Jersey, United States, 08043
United States, New York
Bay Dental PC
Brooklyn, New York, United States, 11229
Ying Wong, DDS
New York, New York, United States, 10024
Martin Man, DMD
New York, New York, United States, 10038
Kay T. Oen, DDS
Port Chester, New York, United States, 10573
Janice K. Pliszczak, DDS
Syracuse, New York, United States, 13215
United States, Ohio
Susan D. Bernstein, DDS
Cincinnati, Ohio, United States, 45231
United States, Pennsylvania
Dr. Jeannette Abboud-Niemczyk
Drexel Hill, Pennsylvania, United States, 19026
Allan J Horowitz, DMD
King of Prussia, Pennsylvania, United States, 19406
Dr. Julie Ann Barna
Lewisburg, Pennsylvania, United States, 17837
Sponsors and Collaborators
Pearl Network
Investigators
Principal Investigator: Frederick A Curro, DMD, PhD New York University School of Medicine
  More Information

Additional Information:
Publications:
AASM (2001). The international classification of sleep disorders, revised: diagnosis and coding manual. Westchester, IL: American Academy of Sleep Medicine.
Lavigne GJ, Manzini C, Kato T (2005). Sleep Bruxism. In: Principles and practice of sleep medicine. MH Kryger, T Roth and WC Dement editors. Philadelphia: Elsevier, pp. 946-59

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pearl Network
ClinicalTrials.gov Identifier: NCT00867997     History of Changes
Other Study ID Numbers: PRL0707, U01 DE-016755, 116358
Study First Received: March 23, 2009
Last Updated: February 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Pearl Network:
Noncarious Cervical Lesions
Hypersensitivity
Teeth
Dentistry
Practice-based research network

Additional relevant MeSH terms:
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 15, 2014