Caries Prevention Products & Dentinal Hypersensitivity

Hypersensitivity Clinical Trial

Official title:

Comparing Three Caries Prevention Products on Dentinal Hypersensitivity - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136576
• Other study ID #: 11184
• Secondary ID: New Investigator
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: October 2018

Study information

• Verified date: November 2020
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypersensitivity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Saunders RH Jr, Meyerowitz C. Dental caries in older adults. Dent Clin North Am. 2005 Apr;49(2):293-308. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; Tooth/Subject responds to stimulus, but does not request discontinuation of stimulus.; Tooth/Subject responds to stimulus and requests discontinuation or moves from stimulus.; 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