Noncarious Cervical Lesion Treatment Outcomes

Study Overview
=================
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.

Official Title
-----------------
Noncarious Cervical Lesion Treatment Outcomes: Randomized Clinical Trial

Conditions
-----------------
Noncarious Cervical Lesions

Intervention / Treatment
-----------------
* Other: Chemoactive (remineralizing, neuroactive) dentifrice treatment
* Other: Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F
* Other: Clearfil S3 Bond; Premise Flowable resin-based composite


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dentifrice<br>Chemoactive (remineralizing, neuroactive) dentifrice treatment | Other: Chemoactive (remineralizing, neuroactive) dentifrice treatment<br>* Chemoactive (remineralizing, neuroactive) dentifrice treatment<br>|
| Active Comparator: Sealant<br>DBA/sealant application | Other: Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F<br>* Self-etch DBA followed by a hydrophobic resin layer<br>|
| Active Comparator: Resin-based composite<br>Restoration with a dentin bonding agent (DBA) and flowable resin-based composite | Other: Clearfil S3 Bond; Premise Flowable resin-based composite<br>* Restoration with a dentin bonding agent (DBA) and flowable resin-based composite<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Baseline, 1, 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Noncarious Cervical Lesions, Hypersensitivity, Teeth, Dentistry, Practice-based research network