Study to Investigate the Effect of Changes in Dentinal Hypersensitivity on Oral Health Parameters

Study to Investigate the Effect of Changes in Dentinal Hypersensitivity on Oral Health Parameters

This exploratory study will investigate the effect of long-term management of Dentine Hypersensitivity (DH) by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene (as measured by supra-gingival plaque accumulation), with associated changes in gingival health.

This is a single center, non-comparative design study to investigate the effect of long-term management of DH by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene, with associated changes in gingival health. Sufficient participants will be screened to ensure approximately 70 eligible participants get allocated the study toothpaste in order to ensure that approximately 60 participants complete the study.

Inclusion Criteria:

• Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

• Understands and is willing, able and likely to comply with all study procedures and restrictions.

• Good general and mental health with, in the opinion of the investigator,

  1. No clinically significant or relevant abnormalities of medical history or oral examination which could impact study outcomes.
  2. The absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.

• At screening, self-reported history of DH lasting more than 6 months but not more than 10 years.

• At screening, minimum of two accessible teeth (incisors, canines or pre-molars) that meet all of the following criteria:

  1. Tooth with signs of erosion, abrasion and/or facial/cervical gingival recession (EAR).
  2. Tooth with signs of sensitivity measured by qualifying evaporative (air) assessment.

• At Baseline, minimum of two accessible teeth (incisors, canines or pre-molars), that meet the following criteria:

  1. Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple less than or equal to [<=] 20 gram) and evaporative (air) assessment (Schiff Sensitivity Score greater than or equal to [>=] 2)

Exclusion Criteria:

• Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.

• Women who are breast-feeding.

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

• Clinical Study/Experimental Medication

  1. Participation in another clinical study or receipt of an investigational drug within 30 days prior to the screening visit.
  2. Participation in a tooth desensitizing treatment study within 8 weeks of the screening visit.
  3. Previous participation in this study.

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

• An employee of the sponsor or the study site or members of their immediate family.

• Disease

  1. Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
  2. Any condition which, in the opinion of the investigator, is causing xerostomia.

• General Dentition Exclusions

  1. Dental prophylaxis within 4 weeks of screening.
  2. Tongue or lip piercing
  3. Desensitizing treatment within 8 weeks of screening (professional sensitivity treatments and non-dentifrice sensitivity treatments).
  4. Treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planing within 3 months of screening.
  5. Teeth bleaching within 8 weeks of screening.
  6. Current active caries or periodontitis which, in the opinion of the investigator, could affect study outcomes, or the health of the subject if they participate in the study.
  7. Partial dentures, orthodontic appliances or dental implants which, in the opinion of the investigator, could affect study outcomes.
  8. Restorations in a poor state of repair which, in the opinion of the investigator, could affect study outcomes.

• Specific Dentition Exclusions for Teeth Selected for Sensitivity Assessments

  1. Tooth with evidence of current or recent caries or reported treatment of decay in 12 months of screening.
  2. 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.
  3. Sensitive tooth not expected, in the opinion of the investigator, to respond to treatment with an over-the-counter toothpaste.

• Use of a sensitivity oral care product within 8 weeks of screening.

• Any participants who, in the opinion of the investigator, should not participate in the study, use of medication which could interfere in the outcome of the study or require antibiotic prophylaxis for dental procedures.