Noncarious Cervical LesionsPhase 3NCT00867997

Noncarious Cervical Lesion Treatment Outcomes

A Phase 3 study testing Chemoactive (remineralizing, neuroactive) dentifrice treatment, Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F and Clearfil S3 Bond; Premise Flowable resin-based composite in people with Noncarious Cervical Lesions, run by Pearl Network at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Noncarious Cervical Lesions
What is being tested?: Chemoactive (remineralizing, neuroactive) dentifrice treatment, Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F and Clearfil S3 Bond; Premise Flowable resin-based composite
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 304 participants
Where: 17 sitesUnited States
Study dates: Mar 2009to Feb 2012
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Bay Dental PC
Brooklyn, New York, 11229
Susan D. Bernstein, DDS
Cincinnati, Ohio, 45231
Scott B Schaffer, DMD
Clark, New Jersey, 07066
Maryann Lehmann, DDS
Darien, Connecticut, 06820
Dr. Jeannette Abboud-Niemczyk
Drexel Hill, Pennsylvania, 19026
Gentle Dental Care, LLC
Edison, New Jersey, 08820
Allan J Horowitz, DMD
King of Prussia, Pennsylvania, 19406
Dr. Julie Ann Barna
Lewisburg, Pennsylvania, 17837
Ying Wong, DDS
New York, New York, 10024
Martin Man, DMD
New York, New York, 10038
Dr. Howard Spielman
Plainsboro, New Jersey, 08536
Kay T. Oen, DDS
Port Chester, New York, 10573
Ahmad Soolari, D.M.D.
Potomac, Maryland, 20854
Oral Health Center
Southborough, Massachusetts, 01772
Janice K. Pliszczak, DDS
Syracuse, New York, 13215
Drs. Martin & Ferraiolo
Totowa, New Jersey, 07512
Cynthia Jetter, DMD
Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

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.

Conditions: Noncarious Cervical Lesions
Being tested: Chemoactive (remineralizing, neuroactive) dentifrice treatment, Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F, Clearfil S3 Bond; Premise Flowable resin-based composite
Keywords: Noncarious Cervical Lesions, Hypersensitivity, Teeth, Dentistry, Practice-based research network
Medical subject headings: Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00867997
Study group	Role	What they receive
Dentifrice	Active comparator	Chemoactive (remineralizing, neuroactive) dentifrice treatment Receives: Other: Chemoactive (remineralizing, neuroactive) dentifrice treatment
Sealant	Active comparator	DBA/sealant application Receives: Other: Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner F
Resin-based composite	Active comparator	Restoration with a dentin bonding agent (DBA) and flowable resin-based composite Receives: Other: Clearfil S3 Bond; Premise Flowable resin-based composite

What is being measured

The primary outcome is the main question the study is designed to answer.

To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups.
Measured: Baseline, 1, 3 and 6 months

Secondary outcomes (1)

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.
Measured: Baseline, 1, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Feb 2012

First posted24 Mar 2009 (estimated)
Study startMar 2009
Primary completionJul 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Noncarious Cervical LesionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00867997
Sponsor's protocol ID: PRL0707
Other IDs: U01DE016755, 116358
Status last verified: Feb 2012
First submitted: 23 Mar 2009
Last updated: 29 Feb 2012
Results posted: No
Data monitoring committee: Yes

Publications

AASM (2001). The international classification of sleep disorders, revised: diagnosis and coding manual. Westchester, IL: American Academy of Sleep Medicine.
Absi EG, Addy M, Adams D. Dentine hypersensitivity. The development and evaluation of a replica technique to study sensitive and non-sensitive cervical dentine. J Clin Periodontol. 1989 Mar;16(3):190-5. doi: 10.1111/j.1600-051x.1989.tb01639.x.
PubMed 2656768
Bader JD, Levitch LC, Shugars DA, Heymann HO, McClure F. How dentists classified and treated non-carious cervical lesions. J Am Dent Assoc. 1993 May;124(5):46-54. doi: 10.14219/jada.archive.1993.0112.
PubMed 8482781
Bader JD, McClure F, Scurria MS, Shugars DA, Heymann HO. Case-control study of non-carious cervical lesions. Community Dent Oral Epidemiol. 1996 Aug;24(4):286-91. doi: 10.1111/j.1600-0528.1996.tb00861.x.
PubMed 8871039
Bartlett DW, Shah P. A critical review of non-carious cervical (wear) lesions and the role of abfraction, erosion, and abrasion. J Dent Res. 2006 Apr;85(4):306-12. doi: 10.1177/154405910608500405.
PubMed 16567549
Burke FJ, Whitehead SA, McCaughey AD. Contemporary concepts in the pathogenesis of the Class V non-carious lesion. Dent Update. 1995 Jan-Feb;22(1):28-32.
PubMed 7664969
Ceruti P, Menicucci G, Mariani GD, Pittoni D, Gassino G. Non carious cervical lesions. A review. Minerva Stomatol. 2006 Jan-Feb;55(1-2):43-57. English, Italian.
PubMed 16495872
Duran I, Sengun A. The long-term effectiveness of five current desensitizing products on cervical dentine sensitivity. J Oral Rehabil. 2004 Apr;31(4):351-6. doi: 10.1046/j.1365-2842.2003.01241.x.
PubMed 15089941
Gillam DG, Newman HN, Davies EH, Bulman JS, Troullos ES, Curro FA. Clinical evaluation of ferric oxalate in relieving dentine hypersensitivity. J Oral Rehabil. 2004 Mar;31(3):245-50. doi: 10.1046/j.0305-182X.2003.01230.x.
PubMed 15025657
Ide M, Morel AD, Wilson RF, Ashley FP. The role of a dentine-bonding agent in reducing cervical dentine sensitivity. J Clin Periodontol. 1998 Apr;25(4):286-90. doi: 10.1111/j.1600-051x.1998.tb02442.x.
PubMed 9565278
Kakaboura A, Rahiotis C, Thomaidis S, Doukoudakis S. Clinical effectiveness of two agents on the treatment of tooth cervical hypersensitivity. Am J Dent. 2005 Aug;18(4):291-5.
PubMed 16296439
Kerns DG, Scheidt MJ, Pashley DH, Horner JA, Strong SL, Van Dyke TE. Dentinal tubule occlusion and root hypersensitivity. J Periodontol. 1991 Jul;62(7):421-8. doi: 10.1902/jop.1991.62.7.421.
PubMed 1920008
Levitch LC, Bader JD, Shugars DA, Heymann HO. Non-carious cervical lesions. J Dent. 1994 Aug;22(4):195-207. doi: 10.1016/0300-5712(94)90107-4.
PubMed 7962894
LittleStar ML, Summitt JB. Non-carious cervical lesions: an evidenced-based approach to their diagnosis. Tex Dent J. 2003 Oct;120(10):972-80. No abstract available.
PubMed 14619725
Lussi A, Schaffner M. Progression of and risk factors for dental erosion and wedge-shaped defects over a 6-year period. Caries Res. 2000 Mar-Apr;34(2):182-7. doi: 10.1159/000016587.
PubMed 10773637

Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Noncarious Cervical Lesion Treatment Outcomes: Randomized Clinical Trial
ClinicalTrials.gov ID: NCT00867997
Acronym / sponsor ID: PRL0707
Conditions: Noncarious Cervical Lesions
Keywords: Noncarious Cervical Lesions, Hypersensitivity, Teeth, Dentistry, Practice-based research network
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 304 participants (actual)
Lead sponsor: Pearl NetworkResearch network
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Study start: Mar 2009
Primary completion: Jul 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 24 Mar 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Specific Aim 1: To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dentifrice	Active comparator	Other: Chemoactive (remineralizing, neuroactive) dentifrice treatmentChemoactive (remineralizing, neuroactive) dentifrice treatment
Sealant	Active comparator	Other: Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner FDBA/sealant application
Resin-based composite	Active comparator	Other: Clearfil S3 Bond; Premise Flowable resin-based compositeRestoration with a dentin bonding agent (DBA) and flowable resin-based composite

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chemoactive (remineralizing, neuroactive) dentifrice treatmentChemoactive (remineralizing, neuroactive) dentifrice treatment	Other	Dentifrice
Clearfil S3 Bond; Clearfil Liner Bond 2 Protect Liner FSelf-etch DBA followed by a hydrophobic resin layer	Other	Sealant
Clearfil S3 Bond; Premise Flowable resin-based compositeRestoration with a dentin bonding agent (DBA) and flowable resin-based composite	Other	Resin-based composite

Primary outcome

To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups.
Time frame: Baseline, 1, 3 and 6 months

1 secondary outcome

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.
Time frame: Baseline, 1, 3 and 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
BackgroundAASM (2001). The international classification of sleep disorders, revised: diagnosis and coding manual. Westchester, IL: American Academy of Sleep Medicine.
Background: PubMed 2656768Absi EG, Addy M, Adams D. Dentine hypersensitivity. The development and evaluation of a replica technique to study sensitive and non-sensitive cervical dentine. J Clin Periodontol. 1989 Mar;16(3):190-5. doi: 10.1111/j.1600-051x.1989.tb01639.x.
Background: PubMed 8482781Bader JD, Levitch LC, Shugars DA, Heymann HO, McClure F. How dentists classified and treated non-carious cervical lesions. J Am Dent Assoc. 1993 May;124(5):46-54. doi: 10.14219/jada.archive.1993.0112.
Background: PubMed 8871039Bader JD, McClure F, Scurria MS, Shugars DA, Heymann HO. Case-control study of non-carious cervical lesions. Community Dent Oral Epidemiol. 1996 Aug;24(4):286-91. doi: 10.1111/j.1600-0528.1996.tb00861.x.
Background: PubMed 16567549Bartlett DW, Shah P. A critical review of non-carious cervical (wear) lesions and the role of abfraction, erosion, and abrasion. J Dent Res. 2006 Apr;85(4):306-12. doi: 10.1177/154405910608500405.
Background: PubMed 7664969Burke FJ, Whitehead SA, McCaughey AD. Contemporary concepts in the pathogenesis of the Class V non-carious lesion. Dent Update. 1995 Jan-Feb;22(1):28-32.
Background: PubMed 16495872Ceruti P, Menicucci G, Mariani GD, Pittoni D, Gassino G. Non carious cervical lesions. A review. Minerva Stomatol. 2006 Jan-Feb;55(1-2):43-57. English, Italian.
Background: PubMed 15089941Duran I, Sengun A. The long-term effectiveness of five current desensitizing products on cervical dentine sensitivity. J Oral Rehabil. 2004 Apr;31(4):351-6. doi: 10.1046/j.1365-2842.2003.01241.x.
Background: PubMed 15025657Gillam DG, Newman HN, Davies EH, Bulman JS, Troullos ES, Curro FA. Clinical evaluation of ferric oxalate in relieving dentine hypersensitivity. J Oral Rehabil. 2004 Mar;31(3):245-50. doi: 10.1046/j.0305-182X.2003.01230.x.
Background: PubMed 9565278Ide M, Morel AD, Wilson RF, Ashley FP. The role of a dentine-bonding agent in reducing cervical dentine sensitivity. J Clin Periodontol. 1998 Apr;25(4):286-90. doi: 10.1111/j.1600-051x.1998.tb02442.x.
Background: PubMed 16296439Kakaboura A, Rahiotis C, Thomaidis S, Doukoudakis S. Clinical effectiveness of two agents on the treatment of tooth cervical hypersensitivity. Am J Dent. 2005 Aug;18(4):291-5.
Background: PubMed 1920008Kerns DG, Scheidt MJ, Pashley DH, Horner JA, Strong SL, Van Dyke TE. Dentinal tubule occlusion and root hypersensitivity. J Periodontol. 1991 Jul;62(7):421-8. doi: 10.1902/jop.1991.62.7.421.
PEARL Network websiteLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frederick A Curro, DMD, PhD principal investigator

NYU Langone Health

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the reduction of hypersensitivity of study teeth by both measurement and by patient-reported outcomes among three treatment groups. (time frame: Baseline, 1, 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00867997, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2012.