Noncarious Cervical Lesions Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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