Mode
Text Size
Log in / Sign up
N/A N=104 Randomized Single-blind Treatment

Clinical Study to Evaluate the Anti-sensitivity Efficacy of a Stannous Fluoride Toothpaste in a Population of Dentin Hypersensitivity Sufferers

Dentin Sensitivity

Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56 — -2.25; -0.31 score on a scale — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Stannous fluoride toothpaste (Drug); Crest cavity protection toothpaste (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
HALEON
Primary completion
Jun 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56
-2.25; -0.31 <0.0001 sig
SECONDARY
Adjusted Mean Change From Baseline in Tactile Threshold at Day 56
60.07; 2.70 <0.0001 sig
SECONDARY
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28
-1.75; -0.10 <0.0001 sig
SECONDARY
Adjusted Mean Change From Baseline in Tactile Threshold at Day 28
36.59; 1.23 <0.0001 sig
SECONDARY
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
-1.44; -0.61; -2.83; -0.71; -1.69; -0.53 0.1268
SECONDARY
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56
-14.79; -7.47; -34.56; -8.94 0.1884
SECONDARY
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56
-2.27; -1.20; -4.94; -1.90 0.3003
SECONDARY
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56
-6.45; -1.73; -12.42; -3.31 0.0784
SECONDARY
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56
-1.23; -0.94; -3.63; -0.24 0.8686
SECONDARY
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56
-4.10; -3.33; -10.23; -2.98 0.9047
SECONDARY
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56
-0.69; -0.27; -3.34; -0.51 0.5733
SECONDARY
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56
-0.15; -0.10; -0.23; -0.06 0.2768
SECONDARY
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56
-0.80; -0.53; -1.93; -0.71 0.8996

Summary

The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste.

Eligibility Criteria

Inclusion Criteria

  • Participant provision of signed and dated informed consent before any study procedures are performed.
  • Participant is male or female.
  • Participant is 18 to 65 years of age, inclusive, at the time of signing the informed consent.
  • Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
  • Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination, that would impact their safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
  • Screening (Visit 1): Participant must have-
  • History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
  • Good general oral health, with a minimum of 20 natural teeth.
  • Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria:
  • Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR).
  • Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only).
  • Clinical mobility = 0
  • Clinically confirmed DH to both tactile and evaporative (air) stimuli: a) Qualifying tactile threshold less 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 different quadrants, with clinically confirmed DH to both tactile and evaporative (air) stimuli at both screening (Visit 1) and baseline (Visit 2).
  • Qualifying tactile threshold = 2 at screening and baseline.
  • The clinical examiner will select two 'Test Teeth' from those which meet the tactile threshold and Schiff sensitivity score inclusion criteria at both screening and baseline. Notes: All teeth with clinically confirmed, qualifying levels of DH at screening (that is, a screening tactile threshold = 2) will be assessed for tactile sensitivity at baseline. Teeth with a baseline tactile threshold <= 20g will then be assessed for baseline evaporative (air) sensitivity.

Exclusion Criteria

  • Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
  • Participant is an employee of the sponsor directly involved in the conduct of the study 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 study products, any of their stated ingredients or closely related compounds (self-reported).
  • Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
  • Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
  • Participant has participated in a tooth sensitivity study within 8 weeks of screening (Visit 1).
  • Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-sensitivity product within 8 weeks of screening (Visit 1). Participants will be required to bring their current oral care products to screening (Visit 1) for staff to verify the absence of known anti-sensitivity ingredients and sensitivity-related claims on the product packaging/label text.
  • Parti
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06359028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search