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Noncarious Cervical Lesion Treatment Outcomes

NCT00867997 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2012-02-29

No results posted yet for this study

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

Interventions

OTHER

Chemoactive (remineralizing, neuroactive) dentifrice treatment

Chemoactive (remineralizing, neuroactive) dentifrice treatment

OTHER

Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F

Self-etch DBA followed by a hydrophobic resin layer

OTHER

Clearfil S3 Bond; Premise Flowable resin-based composite

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

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • Pearl Network

    lead NETWORK

Principal Investigators

  • Frederick A Curro, DMD, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-07-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00867997 on ClinicalTrials.gov