Noncarious Cervical Lesion Treatment Outcomes

NCT00867997 | Completed Phase 3 DMC

• 3 other identifiers: PRL0707U01DE016755116358
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Noncarious Cervical Lesions

Keywords

Noncarious Cervical Lesions; Hypersensitivity; Teeth; Dentistry; Practice-based research network

Outcome Measures

Primary Outcomes (1)

• To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups.

  Baseline, 1, 3 and 6 months

Secondary Outcomes (1)

• 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.

  Baseline, 1, 3 and 6 months

Study Arms (3)

Dentifrice

ACTIVE COMPARATOR

Chemoactive (remineralizing, neuroactive) dentifrice treatment

Other: Chemoactive (remineralizing, neuroactive) dentifrice treatment

Sealant

ACTIVE COMPARATOR

DBA/sealant application

Other: Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F

Resin-based composite

ACTIVE COMPARATOR

Restoration with a dentin bonding agent (DBA) and flowable resin-based composite

Other: Clearfil S3 Bond; Premise Flowable resin-based composite

Interventions

Chemoactive (remineralizing, neuroactive) dentifrice treatment OTHER

Chemoactive (remineralizing, neuroactive) dentifrice treatment

Dentifrice

Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F OTHER

Self-etch DBA followed by a hydrophobic resin layer

Sealant

Clearfil S3 Bond; Premise Flowable resin-based composite OTHER

Restoration with a dentin bonding agent (DBA) and flowable resin-based composite

Resin-based composite

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pearl Network: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (17)

Maryann Lehmann, DDS

Darien, Connecticut, 06820, United States

Location

Ahmad Soolari, D.M.D.

Potomac, Maryland, 20854, United States

Location

Oral Health Center

Southborough, Massachusetts, 01772, United States

Location

Scott B Schaffer, DMD

Clark, New Jersey, 07066, United States

Location

Gentle Dental Care, LLC

Edison, New Jersey, 08820, United States

Location

Dr. Howard Spielman

Plainsboro, New Jersey, 08536, United States

Location

Drs. Martin & Ferraiolo

Totowa, New Jersey, 07512, United States

Location

Cynthia Jetter, DMD

Voorhees Township, New Jersey, 08043, United States

Location

Bay Dental PC

Brooklyn, New York, 11229, United States

Location

Ying Wong, DDS

New York, New York, 10024, United States

Location

Martin Man, DMD

New York, New York, 10038, United States

Location

Kay T. Oen, DDS

Port Chester, New York, 10573, United States

Location

Janice K. Pliszczak, DDS

Syracuse, New York, 13215, United States

Location

Susan D. Bernstein, DDS

Cincinnati, Ohio, 45231, United States

Location

Dr. Jeannette Abboud-Niemczyk

Drexel Hill, Pennsylvania, 19026, United States

Location

Allan J Horowitz, DMD

King of Prussia, Pennsylvania, 19406, United States

Location

Dr. Julie Ann Barna

Lewisburg, Pennsylvania, 17837, United States

Location

Related Publications (33)

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MeSH Terms

Conditions

Hypersensitivity

Interventions

Clearfil S3 Bond

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Frederick A Curro, DMD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 29, 2012

Record last verified: 2012-02

Locations

US (17)