Noncarious Cervical Lesion Treatment Outcomes

February 27, 2012 updated by: Pearl Network

Noncarious Cervical Lesion Treatment Outcomes: Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pearl Network

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Frederick A Curro, DMD, PhD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

March 23, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Estimate)

February 29, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRL0707
  • U01DE016755 (U.S. NIH Grant/Contract)
  • 116358

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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