A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers

Last updated: September 9, 2024
Sponsor: HALEON
Overall Status: Completed

Phase

N/A

Condition

Allergies & Asthma

Allergy (Pediatric)

Allergy

Treatment

CSPS toothpaste

Regular fluoride toothpaste (Crest Cavity Protection)

Clinical Study ID

NCT06378008
300100
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate (CSPS) toothpaste.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant provision of signed and dated informed consent before any studyprocedures are performed.

  • Participant is male or female.

  • Participant is 18 to 65 years of age, inclusive, at the time of signing the informedconsent.

  • Participant is willing and able to comply with the study visit schedule, productusage instructions, lifestyle restrictions and other study procedures.

  • Participant is in good general, oral and mental health with, in the opinion of theinvestigator or medically qualified designee, no clinically significant or relevantabnormalities in self-reported medical history, or upon oral examination, that wouldimpact their safety or wellbeing, or the outcomes of the study, if they were toparticipate in the study, or affect their ability to understand and follow studyrequirements.

  • Screening (visit 1): Participant must have

  1. History of tooth sensitivity lasting more than six months but not more than 10years (self-reported).

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

  3. Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), indifferent quadrants, which meet all of the following criteria:

  4. Exposed dentin due to facial/cervical erosion, abrasion or gingivalrecession (EAR).

  5. Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only).

  6. Clinical mobility = 0

  7. Clinically confirmed DH to both tactile and evaporative (air) stimuli: a)Qualifying tactile threshold less than or equal to (<=) 20g. b) QualifyingSchiff sensitivity score greater than or equal to (>=) 2.

  • Baseline (Visit 2, Pre-Treatment): Participant must have a minimum of two,non-adjacent accessible teeth (incisors, canines, premolars), in differentquadrants, with clinically confirmed DH to both tactile and evaporative (air)stimuli at both screening (Visit 1) and baseline (Visit 2). a) Qualifying tactilethreshold <= 20g at screening and baseline. b) Qualifying Schiff sensitivity score >= 2 at screening and baseline.

Exclusion

Exclusion Criteria:

  • Participant is an employee of the investigator site directly involved in the conductof the study, or an employee of the investigator site otherwise supervised by theinvestigator, or a member of their immediate family.

  • Participant is an employee of the sponsor directly involved in the conduct of thestudy or a member of their immediate family.

  • Female participant who is pregnant or intending to become pregnant during the study (self-reported).

  • Female participant who is breastfeeding (self-reported).

  • Participant with known or suspected intolerance or hypersensitivity to the studyproducts, any of their stated ingredients or closely related compounds (self-reported).

  • Participant with a recent history (within the last year) of alcohol or othersubstance abuse (self-reported).

  • Participant is participating in or has participated in other studies (includingnon-medicinal studies) involving investigational product(s) within 30 days ofscreening (Visit 1) or plans to participate in other studies (includingnon-medicinal studies) during this study.

  • Participant has participated in a tooth sensitivity study within 8 weeks ofscreening (Visit 1).

  • Participant is currently using an oral care product indicated for DH relief or careof sensitive teeth or has used an anti-sensitivity product within 8 weeks ofscreening (Visit 1). Participants will be required to bring their current oral careproducts to screening (Visit 1) for staff to verify the absence of knownanti-sensitivity ingredients and sensitivity-related claims on the productpackaging/label text.

  • Participant takes daily doses of medications/treatments which, in the opinion of theinvestigator or medically qualified designee, could interfere with their perceptionof tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines thatcause marked or moderate sedation, sedatives, tranquilizers, antidepressants,mood-altering and anti-inflammatory drugs).

  • Screening (Visit 1): Participant has taken antibiotics in the 2 weeks prior toscreening (Visit 1).

  • Baseline (Visit 2, Pre-Treatment): Participant has taken antibiotics in the 2 weeksprior to baseline (Visit 2), that is, during the acclimatization period.

  • Participant takes daily doses of a medication which, in the opinion of theinvestigator or medically qualified designee, is causing xerostomia.

  • Participant requires antibiotic prophylaxis for dental procedures.

  • Participant has had professional tooth de-sensitising treatment within 8 weeks ofscreening (Visit 1).

  • Participant has had a tooth bleaching procedure within 8 weeks of screening (Visit 1).

  • Participant has had dental prophylaxis within 4 weeks of screening (Visit 1).

  • Participant has had treatment for periodontal disease (including surgery) within 12months of screening (Visit 1).

  • Participant has had scaling or root planning within 3 months of screening (Visit 1).

  • Participant with gross periodontal disease.

  • Participant with a tongue or lip piercing.

  • Participant with evidence of gross intra-oral neglect or the need for extensivedental therapy.

  • Participant with a fixed or removable partial prosthesis which, in the opinion ofthe investigator or dentally qualified designee, could impact study outcomes.

  • Participant with multiple dental implants which, in the opinion of the investigatoror dentally qualified designee, could impact study outcomes.

  • Participant with fixed or removable orthodontic braces/bands or a fixed orthodonticretainer.

  • Specific dentition exclusions for 'Test teeth':

  1. Tooth with evidence of current/recent caries.

  2. Tooth with (self-reported) treatment for decay within 12 months of screening (Visit 1).

  3. Tooth with exposed dentin and deep, defective or facial restorations.

  4. Tooth with a full crown or veneer.

  5. Tooth adjacent to a bridge abutment or crown which, in the opinion of theinvestigator or dentally qualified designee, could impact study outcomes.

  6. Sensitive tooth with contributing etiologies other than EAR to exposed dentin.

  7. Sensitive tooth not expected to benefit from use of an anti-sensitivitytoothpaste, in the opinion of the investigator or dentally qualified designee.

  • Participant has previously been enrolled in this study.

  • Participant who, in the opinion of the investigator or medically qualified designee,should not participate in the study.

Study Design

Total Participants: 217
Treatment Group(s): 2
Primary Treatment: CSPS toothpaste
Phase:
Study Start date:
April 16, 2024
Estimated Completion Date:
September 04, 2024

Study Description

This will be a single center, 8-week, randomized, controlled, examiner-blind, 2-treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected 'test teeth') clinical study to evaluate the anti-sensitivity efficacy of a 5% CSPS toothpaste in a DH population. The clinical efficacy of the 5% CSPS toothpaste (test toothpaste) will be compared with that of a reference toothpaste, a commercially available, regular fluoride toothpaste with no known anti-sensitivity properties (negative control). Sufficient participants will be screened to randomize approximately 234 participants to investigational product (approximately 117 per treatment group) and to ensure approximately 210 evaluable participants complete the entire study (approximately 105 per treatment group).

Connect with a study center

  • All Sum Research

    Mississauga, Ontario L5N 6J2
    Canada

    Site Not Available

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