Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 55
Updated:6/29/2016
Start Date:September 2015
End Date:December 2015

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A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity

This study will investigate the longitudinal efficacy of two experimental oral rinses
containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH
4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a
placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride
toothpaste.


Inclusion Criteria:

- Demonstrates understanding of the study procedures, restrictions and willingness to
participate as evidenced by voluntary written informed consent and has received a
signed and dated copy of the informed consent form

- Aged between 18 and 55 years inclusive

- Good general and mental health with, in the opinion of the investigator or medically
qualified designee:

A. No clinically significant and relevant abnormalities in medical history or upon oral
examination.

B. Absence of any condition that would impact on the subject's safety or wellbeing or
affect the individual's ability to understand and follow study procedures and
requirements.

- Dental health

At Screening:

A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months
but not more than 10 years.

B. Good general oral health, with a minimum of 20 natural teeth.

C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably
in different quadrants, that meet all of the following criteria:

- Signs of facial/cervical gingival recession and/or signs of erosion or abrasion
(EAR).

- Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed
dentine) only and a clinical mobility of ≤1.

- Tooth with signs of sensitivity measured by qualifying evaporative air assessment
(Y/N response).

At Baseline:

D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that
meet all of the following criteria:

- Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g)
and evaporative air assessment (Schiff Sensitivity Score ≥ 2)

Exclusion Criteria:

- Pregnant or breast feeding women

- Daily doses of medication/treatments which, in the opinion of the investigator, could
interfere with the perception of pain.

- Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.

- Daily dose of a medication which, in the opinion of the investigator, is causing
xerostomia.

- Presence of kidney disease, hyperoxaluria, or any other condition that may be
exacerbated by oxalic acid or oxalate salts.

- Presence of chronic debilitating disease which, in the opinion of the investigator,
could affect study outcomes.

- Any condition which, in the opinion of the investigator, causes xerostomia.

- Treatment of periodontal disease within 12 months of screening

- Known or suspected intolerance or hypersensitivity to the study materials (or closely
related compounds) or any of their stated ingredients

- Participation in another clinical study (including cosmetic studies) or receipt of an
investigational drug within 30 days of the screening visit.

- Recent history (within the last year) of alcohol or other substance abuse

- Dental prophylaxis within four weeks of Screening.

- Tongue or lip piercing or presence of dental implants.

- Desensitizing treatment within eight weeks of Screening (professional sensitivity
treatments and non-toothpaste sensitivity treatments).

- Gross periodontal disease, treatment of periodontal disease (including surgery)
within 12 months of Screening, scaling or root planning within 3 months of Screening.

- Teeth bleaching within eight weeks of Screening

- Tooth with evidence of current or recent caries, or reported treatment of decay
within 12 months of Screening.

- Tooth with exposed dentine but with deep, defective or facial restorations, teeth
used as abutments for fixed or removable partial dentures, teeth with full crowns or
veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing
aetiologies other than erosion, abrasion or recession of exposed dentine.

- Sensitive tooth not expected to respond to treatment with an over-the-counter
toothpaste in the opinion of the investigator.

- Use of an oral care product indicated for the relief of dentine hypersensitivity
within eight weeks of screening

- Individuals who require antibiotic prophylaxis for dental procedures
We found this trial at
1
site
Las Vegas, Nevada 89102
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mi
from
Las Vegas, NV
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