Noncarious Cervical Lesion Treatment Outcomes

Noncarious Cervical Lesions Clinical Trial

Official title:

Noncarious Cervical Lesion Treatment Outcomes: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867997
• Other study ID #: PRL0707
• Secondary ID: U01DE01675511635
• Status: Completed
• Phase: Phase 3
• First received: March 23, 2009
• Last updated: February 27, 2012
• Start date: March 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Pearl Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: February 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Noncarious Cervical Lesions
• Uterine Cervical Diseases

Intervention

Other:
• Chemoactive (remineralizing, neuroactive) dentifrice treatment
Chemoactive (remineralizing, neuroactive) dentifrice treatment
• Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F
Self-etch DBA followed by a hydrophobic resin layer
• Clearfil S3 Bond; Premise Flowable resin-based composite
Restoration with a dentin bonding agent (DBA) and flowable resin-based composite

Locations

Country	Name	City	State
United States	Bay Dental PC	Brooklyn	New York
United States	Susan D. Bernstein, DDS	Cincinnati	Ohio
United States	Scott B Schaffer, DMD	Clark	New Jersey
United States	Maryann Lehmann, DDS	Darien	Connecticut
United States	Dr. Jeannette Abboud-Niemczyk	Drexel Hill	Pennsylvania
United States	Gentle Dental Care, LLC	Edison	New Jersey
United States	Allan J Horowitz, DMD	King of Prussia	Pennsylvania
United States	Dr. Julie Ann Barna	Lewisburg	Pennsylvania
United States	Martin Man, DMD	New York	New York
United States	Ying Wong, DDS	New York	New York
United States	Dr. Howard Spielman	Plainsboro	New Jersey
United States	Kay T. Oen, DDS	Port Chester	New York
United States	Ahmad Soolari, D.M.D.	Potomac	Maryland
United States	Oral Health Center	Southborough	Massachusetts
United States	Janice K. Pliszczak, DDS	Syracuse	New York
United States	Drs. Martin & Ferraiolo	Totowa	New Jersey
United States	Cynthia Jetter, DMD	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Pearl Network	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   PEARL Network website