CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 304 enrolled
Drug / intervention
Chemoactive (remineralizing, neuroactive) dentifrice treatment +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00867997
NCT00867997Phase 3Completed

Noncarious Cervical Lesion Treatment Outcomes: Randomized Clinical Trial

Pearl Network·interventional·Posted Mar 24, 2009·Updated Feb 29, 2012

In Brief

A Phase 3 clinical trial evaluating Chemoactive (remineralizing, neuroactive) dentifrice treatment, Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F, and 1 other intervention for Noncarious Cervical Lesions. Completed, enrolled 304 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 24, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.3 years ago

Interventions

Chemoactive (remineralizing, neuroactive) dentifrice treatmentother

Chemoactive (remineralizing, neuroactive) dentifrice treatment

Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner Fother

Self-etch DBA followed by a hydrophobic resin layer

Clearfil S3 Bond; Premise Flowable resin-based compositeother

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