NCT02136576

Caries Prevention Products & Dentinal Hypersensitivity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hypersensitivity

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2014-05-13
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Locations

1 site across 1 country: United States