Clinical trial NCT00867997: Noncarious Cervical Lesion Treatment Outcomes
Official title: Noncarious Cervical Lesion Treatment Outcomes: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Noncarious Cervical Lesions
Keywords: Noncarious Cervical Lesions
Hypersensitivity
Teeth
Dentistry
Practice-based research network
Lead sponsor: Pearl Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2009-03-24
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups.
timeFrame: Baseline, 1, 3 and 6 months
Secondary outcomes:
measure: 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.
timeFrame: Baseline, 1, 3 and 6 months
Other outcomes:
Locations:
city: Darien
country: United States
facility: Maryann Lehmann, DDS
state: Connecticut
city: Potomac
country: United States
facility: Ahmad Soolari, D.M.D.
state: Maryland
city: Southborough
country: United States
facility: Oral Health Center
state: Massachusetts
city: Clark
country: United States
facility: Scott B Schaffer, DMD
state: New Jersey
city: Edison
country: United States
facility: Gentle Dental Care, LLC
state: New Jersey
city: Plainsboro
country: United States
facility: Dr. Howard Spielman
state: New Jersey
city: Totowa
country: United States
facility: Drs. Martin & Ferraiolo
state: New Jersey
city: Voorhees
country: United States
facility: Cynthia Jetter, DMD
state: New Jersey
city: Brooklyn
country: United States
facility: Bay Dental PC
state: New York
city: New York
country: United States
facility: Ying Wong, DDS
state: New York
city: New York
country: United States
facility: Martin Man, DMD
state: New York
city: Port Chester
country: United States
facility: Kay T. Oen, DDS
state: New York
city: Syracuse
country: United States
facility: Janice K. Pliszczak, DDS
state: New York
city: Cincinnati
country: United States
facility: Susan D. Bernstein, DDS
state: Ohio
city: Drexel Hill
country: United States
facility: Dr. Jeannette Abboud-Niemczyk
state: Pennsylvania
city: King of Prussia
country: United States
facility: Allan J Horowitz, DMD
state: Pennsylvania
city: Lewisburg
country: United States
facility: Dr. Julie Ann Barna
state: Pennsylvania
Study officials:
affiliation: NYU Langone Health
name: Frederick A Curro, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
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