Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2014-05-31
2018-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sensodyne
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
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.
Crest Cavity Protection & MI Paste Plus
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
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.
Clinpro 5000
There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
Yes
Sponsors
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Tufts University
OTHER
Responsible Party
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Britta Magnuson
Asst. Professor
Principal Investigators
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Britta Magnuson, DMD
Role: PRINCIPAL_INVESTIGATOR
Tufts University School of Dental Medicine
Locations
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Tufts University School of Dental Medicine
Boston, Massachusetts, United States
Countries
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References
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Hull PS, Worthington HV, Clerehugh V, Tsirba R, Davies RM, Clarkson JE. The reasons for tooth extractions in adults and their validation. J Dent. 1997 May-Jul;25(3-4):233-7. doi: 10.1016/s0300-5712(96)00029-2.
Pradeep AR, Sharma A. Comparison of clinical efficacy of a dentifrice containing calcium sodium phosphosilicate to a dentifrice containing potassium nitrate and to a placebo on dentinal hypersensitivity: a randomized clinical trial. J Periodontol. 2010 Aug;81(8):1167-73. doi: 10.1902/jop.2010.100056.
Yilmaz HG, Kurtulmus-Yilmaz S, Cengiz E. Long-term effect of diode laser irradiation compared to sodium fluoride varnish in the treatment of dentine hypersensitivity in periodontal maintenance patients: a randomized controlled clinical study. Photomed Laser Surg. 2011 Nov;29(11):721-5. doi: 10.1089/pho.2010.2974. Epub 2011 Jun 13.
West NX. Dentine hypersensitivity: preventive and therapeutic approaches to treatment. Periodontol 2000. 2008;48:31-41. doi: 10.1111/j.1600-0757.2008.00262.x. No abstract available.
Saunders RH Jr, Meyerowitz C. Dental caries in older adults. Dent Clin North Am. 2005 Apr;49(2):293-308. doi: 10.1016/j.cden.2004.10.004.
Brahmbhatt N, Bhavsar N, Sahayata V, Acharya A, Kshatriya P. A double blind controlled trial comparing three treatment modalities for dentin hypersensitivity. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e483-90. doi: 10.4317/medoral.17594.
Orsini G, Procaccini M, Manzoli L, Giuliodori F, Lorenzini A, Putignano A. A double-blind randomized-controlled trial comparing the desensitizing efficacy of a new dentifrice containing carbonate/hydroxyapatite nanocrystals and a sodium fluoride/potassium nitrate dentifrice. J Clin Periodontol. 2010 Jun;37(6):510-7. doi: 10.1111/j.1600-051X.2010.01558.x.
Jenson L, Budenz AW, Featherstone JD, Ramos-Gomez FJ, Spolsky VW, Young DA. Clinical protocols for caries management by risk assessment. J Calif Dent Assoc. 2007 Oct;35(10):714-23.
Young DA, Featherstone JD, Roth JR, Anderson M, Autio-Gold J, Christensen GJ, Fontana M, Kutsch VK, Peters MC, Simonsen RJ, Wolff MS. Caries management by risk assessment: implementation guidelines. J Calif Dent Assoc. 2007 Nov;35(11):799-805.
Featherstone JD, Zero DT. An in situ model for simultaneous assessment of inhibition of demineralization and enhancement of remineralization. J Dent Res. 1992 Apr;71 Spec No:804-10. doi: 10.1177/002203459207100S02.
Ito A, Hayashi M, Hamasaki T, Ebisu S. How regular visits and preventive programs affect onset of adult caries. J Dent Res. 2012 Jul;91(7 Suppl):52S-58S. doi: 10.1177/0022034511435701.
Wang JX, Yan Y, Wang XJ. Clinical evaluation of remineralization potential of casein phosphopeptide amorphous calcium phosphate nanocomplexes for enamel decalcification in orthodontics. Chin Med J (Engl). 2012 Nov;125(22):4018-21.
Su N, Marek CL, Ching V, Grushka M. Caries prevention for patients with dry mouth. J Can Dent Assoc. 2011;77:b85.
Kowalczyk A, Botulinski B, Jaworska M, Kierklo A, Pawinska M, Dabrowska E. Evaluation of the product based on Recaldent technology in the treatment of dentin hypersensitivity. Adv Med Sci. 2006;51 Suppl 1:40-2.
Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R. Guidelines for the design and conduct of clinical trials on dentine hypersensitivity. J Clin Periodontol. 1997 Nov;24(11):808-13. doi: 10.1111/j.1600-051x.1997.tb01194.x.
Hughes N, Mason S, Jeffery P, Welton H, Tobin M, O'Shea C, Browne M. A comparative clinical study investigating the efficacy of a test dentifrice containing 8% strontium acetate and 1040 ppm sodium fluoride versus a marketed control dentifrice containing 8% arginine, calcium carbonate, and 1450 ppm sodium monofluorophosphate in reducing dentinal hypersensitivity. J Clin Dent. 2010;21(2):49-55.
Ritter AV, de L Dias W, Miguez P, Caplan DJ, Swift EJ Jr. Treating cervical dentin hypersensitivity with fluoride varnish: a randomized clinical study. J Am Dent Assoc. 2006 Jul;137(7):1013-20; quiz 1029. doi: 10.14219/jada.archive.2006.0324.
Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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New Investigator Grant
Identifier Type: OTHER
Identifier Source: secondary_id
11184
Identifier Type: -
Identifier Source: org_study_id