Status:
COMPLETED
Noncarious Cervical Lesion Treatment Outcomes
Lead Sponsor:
Pearl Network
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Noncarious Cervical Lesions
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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): chemoactiv...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00867997
Start Date
March 1 2009
End Date
February 1 2012
Last Update
February 29 2012
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Maryann Lehmann, DDS
Darien, Connecticut, United States, 06820
2
Ahmad Soolari, D.M.D.
Potomac, Maryland, United States, 20854
3
Oral Health Center
Southborough, Massachusetts, United States, 01772
4
Scott B Schaffer, DMD
Clark, New Jersey, United States, 07066