Caries Prevention Products & Dentinal Hypersensitivity

NCT02136576 | Completed Results

• 2 other identifiers: 11184New Investigator Grant
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Dentinal Hypersensitivity

  The primary analysis will be to compare the dentinal hypersensitivity between the 3 groups. Air test: A 1 second blast of air from the air-water syringe was applied to the tooth. Water test: Three drops of ice water were be placed on the tooth. Schiff Score Investigator observed participant reaction to test and scored on following scale: 0-Tooth/Subject does not respond to stimulus. 1. Tooth/Subject responds to stimulus, but does not request discontinuation of stimulus. 2. Tooth/Subject responds to stimulus and requests discontinuation or moves from stimulus. 3. Tooth/Subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus VAS (visual analog scale): The participant reported sensitivity on a scale of 0-10. 0 being no pain and 10 being worst pain imaginable.

  8 weeks after baseline

Study Arms (3)

Sensodyne

ACTIVE COMPARATOR

There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.

Device: Sensodyne

Crest Cavity Protection & MI Paste Plus

ACTIVE COMPARATOR

There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.

Device: Crest Cavity Protection & MI Paste Plus

Clinpro 5000

ACTIVE COMPARATOR

There are no specific characteristics for inclusion in this group. Enrollment will be determined randomly.

Device: Clinpro 5000

Interventions

Sensodyne DEVICE

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.

Sensodyne

Crest Cavity Protection & MI Paste Plus DEVICE

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.

Crest Cavity Protection & MI Paste Plus

Clinpro 5000 DEVICE

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.

Clinpro 5000

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (18)

• 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.

  PMID: 20370417 BACKGROUND

• 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.

  PMID: 21668343 BACKGROUND

• 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.

  PMID: 18715354 BACKGROUND

• 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.

  PMID: 15755406 BACKGROUND

• 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.

  PMID: 9175351 BACKGROUND

• 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.

  PMID: 22143734 BACKGROUND

• 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.

  PMID: 20507374 BACKGROUND

• 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.

  PMID: 18044379 BACKGROUND

• 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.

  PMID: 18080486 BACKGROUND

• 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.

  PMID: 1592963 BACKGROUND

• 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.

  PMID: 22699669 BACKGROUND

• 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.

  PMID: 23158136 BACKGROUND

• Su N, Marek CL, Ching V, Grushka M. Caries prevention for patients with dry mouth. J Can Dent Assoc. 2011;77:b85.

  PMID: 21774875 BACKGROUND

• 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.

  PMID: 17458057 BACKGROUND

• 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.

  PMID: 9402502 BACKGROUND

• 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.

  PMID: 20669816 BACKGROUND

• 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.

  PMID: 16803829 BACKGROUND

• 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.

  PMID: 18165753 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Dr. Britta Magnuson
• Organization: Tufts University School of Dental Medicine

britta.magnuson@tufts.edu

617-636-3878

Study Officials

• Britta Magnuson, DMD

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 13, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: December 10, 2020
• Results First Posted: December 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)