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Trial record 21 of 33 for:    FLUORIDE ION AND NITRATE ION

Caries Prevention Products & Dentinal Hypersensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02136576
Recruitment Status : Completed
First Posted : May 13, 2014
Last Update Posted : April 18, 2019
Information provided by (Responsible Party):
Tufts University

Brief Summary:

The aim of this pilot research project is to compare the clinical effect on dentinal hypersensitivity of three products: Casein Phosphopeptide-Amorphous Calcium Phosphate (CPP-ACP) paste with fluoride, 5000 Sodium Fluoride (NaF) dentifrice containing Tri-Calcium Phosphate (TCP), and a dentifrice containing Potassium Nitrate.

The hypothesis of this study is that CPP-ACP with fluoride and 5000ppm NaF with TCP will exhibit a greater reduction in dentinal hypersensitivity compared to the control (dentifrice containing Potassium Nitrate).

The results of this pilot study will validate or negate the need for a larger clinical study that may provide generalizable results for using caries-prevention products with the additional benefit of minimizing dentinal hypersensitivity.

Condition or disease Intervention/treatment Phase
Hypersensitivity Device: Sensodyne Device: Crest Cavity Protection & MI Paste Plus Device: Clinpro 5000 Not Applicable

Detailed Description:

Dentinal hypersensitivity commonly occurs in patients with gingival recession, resulting from a reduced periodontium or in patients who have undergone non-surgical and surgical periodontal therapy (Pradeep 2010, Yilmaz 2011). When the gingiva recede, the root surfaces of the teeth are exposed (West 2008). In addition, after a non-surgical or surgical periodontal procedure, the cementum of the root surface is removed as a result of scaling and root planing. This leaves dentin exposed on the root surface with open dentinal tubules. In addition, dentin is less mineralized than enamel and has a greater susceptibility to and a faster progression of root caries and dentinal hypersensitivity (Saunders 2005). Root caries commonly occurs in patients who have undergone periodontal therapy and extensive root caries often results in the extraction of the tooth (Hull 1997).

Dental professionals often make a variety of recommendations to remedy dental hypersensitivity, including the application of fluoride varnishes, anti-hypersensitivity toothpaste, gingival grafting procedures and various restorative procedures, aiming to occlude the dentinal tubules or desensitize the pulpal nerve endings (Brahmbhatt 2012, Orsini 2010).

Since the introduction of Caries Management By Risk Assessment (CAMBRA) in the Journal of the California Dental Association in 2007 (Jenson 2007, Young 2007), the marketplace for anti-caries products has surged. As a result, many approaches to the management of dental caries have been introduced and dental practitioners and sales representatives have promoted several anti-caries products. In addition, the reduction or the abatement of the progression of dental caries (coronal, root and interproximal) as a result of a caries management program has been reported (Featherstone 1992, Ito 2012). Many caries management products have ingredients that include fluoride and calcium phosphate (Amorphous Calcium Phosphate-Casein Phosphopeptide (Recaldent ™), (Wang 2012) Tri-Calcium Phosphate ™ or Novamin ™) (Su 2011). Moreover, encouraging clinical findings have been reported, including, but not limited to the reduction of white spot enamel lesions and dentinal hypersensitivity (Kowalczyk 2006).

The topical application of "antihypersensitivity" materials is a common recommendation (least invasive of the "standard of care" recommendations) to diminish dentinal hypersensitivity and will serve to provide data for the research study. The study will evaluate which of these products result in the greatest reduction of dentinal hypersensitivity. The application of the experimental products for the reduction of dentinal hypersensitivity is for research purposes.

The methods used to test sensitivity in this study have been used in published studies (Brahmbhatt 2012, Holland 1997). The VAS scale used in this study has also been used for tooth sensitivity studies (Holland 1997, Hughes 2010). A 30% decrease in VAS score has been shown to be clinically meaningful (Ritter 2006, Raymond 2008).

This pilot study would investigate the ability of anti-caries products to reduce dentinal hypersensitivity when compared to a sensitivity-reducing dentifrice. It would be a novel contribution to the dental community if a material that is proven to reduce tooth decay is also proven to reduce dentinal hypersensitivity. The results may potentially have a tremendous impact on the dental community because it may provide dental professionals a scientifically-supported approach to improve the comfort and quality of life of periodontal patients (patients who are treated for gum disease/ bone loss around teeth) and increase the lifespan of teeth that undergo periodontal treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparing Three Caries Prevention Products on Dentinal Hypersensitivity - A Pilot Study
Study Start Date : May 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Sensodyne
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Device: Sensodyne
Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study.

Active Comparator: Crest Cavity Protection & MI Paste Plus
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Device: Crest Cavity Protection & MI Paste Plus
Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger.

Active Comparator: Clinpro 5000
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
Device: Clinpro 5000
Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study.

Primary Outcome Measures :
  1. Change in Dentinal Hypersensitivity [ Time Frame: 8 weeks after baseline ]
    The primary analysis will be to compare the percent change in dentinal hypersensitivity between the 3 groups. We assume that the control group may exhibit a modest improvement in dentinal hypersensitivity (~5%) whereas the two test groups should demonstrate a more significant improvement (~30%). Assuming a common standard deviation of 25%, we will have 58% power to detect a difference between the 3 groups using one way analysis of variance, with 10 subjects per group, and setting alpha to 0.05 (nQuery Advisor, Version 7.0). Up to 13 subjects per group will be recruited, to allow for a more than 20% dropout rate.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • At least 18 years of age
  • Tooth with exposed root surface and/or exposed dentin
  • Tooth with a VAS score greater than or equal to 3
  • No adjacent tooth/teeth with sensitivity (as defined as 2 or higher on the VAS)

Exclusion Criteria:

  • Participation in another dental study that may alter the results of this study.
  • A medical condition that could interfere with reliable pain reporting (e.g., pain disorders)
  • Any chronic medical condition that requires the regular use of pain or anti-inflammatory medications
  • Used a desensitizing dentifrice within the preceding four weeks
  • Have received an antihypersensitivity treatment (varnish or precipitating solution) of the identified tooth within the preceding four weeks
  • Undergoing active orthodontic treatment.
  • Teeth with carious lesions, buccal vertical cracks in enamel, evidence of irreversible pulpitis (pain lasting more than five seconds after air stimulation)
  • Pregnant/ lactating patients (Clinpro5000 has 5000ppm fluoride and there is a risk of ingesting the product)
  • Patients with Milk Allergy (CPP-ACP is a dairy based product)
  • Patients on Kidney Dialysis (due to the free calcium in CPP-ACP, dialysis patients should be on a diet with limited calcium)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02136576

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United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
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Principal Investigator: Britta Magnuson, DMD Tufts University School of Dental Medicine


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Responsible Party: Tufts University Identifier: NCT02136576     History of Changes
Other Study ID Numbers: 11184
New Investigator Grant ( Other Identifier: TUSDM )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Immune System Diseases
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents