Caries Prevention Products & Dentinal Hypersensitivity

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.

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)