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

Not Applicable

Completed

Conditions: Dentin Sensitivity

Interventions: Drug: Stannous fluoride toothpaste
Drug: Regular fluoride toothpaste (Crest Cavity Protection)

Registration Number: NCT06354270

Lead Sponsor: HALEON

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

Detailed 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 0.454% SnF2 toothpaste in healthy participants with DH. The clinical efficacy of the 0.454% SnF2 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 110 participants to investigational product (approximately 55 per treatment group) and to ensure approximately 100 evaluable participants complete the entire study (approximately 50 per treatment group).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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
1. History of tooth sensitivity lasting more than six months but not more than 10 years (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), in different quadrants, which meet all of the following criteria:
  1. Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR).
  2. Modified Gingival Index (MGI) = 0 directly adjacent to the exposed dentin (that is, the test area only).
  3. Clinical mobility = 0
  4. Clinically confirmed DH to both tactile and evaporative (air) stimuli: A. Qualifying tactile threshold less than or equal to (<=) 20g. B. Qualifying Schiff sensitivity score more 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).
1. Qualifying tactile threshold <= 20g at Screening and Baseline.
2. Qualifying Schiff sensitivity score >= 2 at Screening and Baseline.

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.
Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines that cause 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 to Screening (Visit 1).
Baseline (Visit 2, Pre-treatment): Participant has taken antibiotics in the 2 weeks prior to Baseline (Visit 2), that is, during the acclimatization period.
Participant takes daily doses of a medication which, in the opinion of the investigator 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 of Screening (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 12 months 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 extensive dental therapy.
Participant with a fixed or removable partial prosthesis which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
Participant with multiple dental implants which, in the opinion of the investigator or dentally qualified designee, could impact study outcomes.
Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer.
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 the investigator 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-sensitivity toothpaste, in the opinion of the investigator or dentally qualified designee.
Participant who, in the opinion of the investigator or designee, is unable to provide appropriate responses to the Labelled Magnitude Scale (LMS) training questions.
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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test toothpaste	Stannous fluoride toothpaste	Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wish to rinse after brushing will be instructed to rinse with 10 milliliter (ml) water using graduated rinsing cup provided.
Reference toothpaste (Negative control)	Regular fluoride toothpaste (Crest Cavity Protection)	Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wish to rinse after brushing will be instructed to rinse with 10 ml water using graduated rinsing cup provided.

Primary Outcome Measures

Name	Time	Method
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56	Baseline (Day 0) and Day 56	Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 56 score. A negative change from Baseline indicated improvement in sensitivity.

Secondary Outcome Measures

Name	Time	Method
Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) at Day 56	Baseline (Day 0) and Day 56	Tactile sensitivity of incisor, canine and pre-molar teeth was assessed using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentin. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting which elicited two consecutive 'yes' responses was recorded as the tactile threshold in gram for that tooth. At Baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated less sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) value from Day 56 value. A positive change from Baseline indicated improvement in sensitivity.
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28	Baseline (Day 0) and Day 28	Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index, scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation;1=Responded to air stimulus but did not request discontinuation of stimulus;2=Responded to air stimulus and requested discontinuation or moved from stimulus;3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score=Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) score from Day 28 score. A negative change from Baseline indicated improvement in sensitivity.
Adjusted Mean Change From Baseline in Tactile Threshold (g) at Day 28	Baseline (Day 0) and Day 28	Tactile sensitivity of incisor, canine and pre-molar teeth was assessed using a constant pressure probe (Yeaple probe). The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentin. After each application of the stimulus, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The gram setting which elicited two consecutive 'yes' responses was recorded as the tactile threshold in gram (g) for that tooth. At Baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at Baseline. Higher tactile threshold indicated less sensitivity. Change from Baseline was calculated by subtracting Baseline (Day 0) value from Day 28 value. A positive change from Baseline indicated an improvement in sensitivity.
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) Score at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	The DHEQ is a condition-specific measure of Oral Health-Related Quality of Life (OHrQoL) used to investigate the impacts of tooth sensitivity on everyday life. DHEQ section 1, questions 7-9 were about participant's sensitive teeth and its impact on their everyday life. Participants scored Q7 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q8 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q9 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranged from 1 to 10; where lower scores indicated less intense, less bothersome and tolerable sensations. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement in sensitivity and its impact on everyday life.
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	The DHEQ is a condition-specific measure of OHrQoL used to investigate the impacts of tooth sensitivity on everyday life. Section 2 of DHEQ included 34 questions grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34). Participants scored each question using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score was derived from the sum of scores across all domains (Q1-34) and ranged from 34 to 238, where lower score indicated better OHrQoL. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from the score at each indicated timepoint. A negative change from Baseline indicated improvement in OHrQoL.
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	Restrictions domain of DHEQ evaluated 'the ways in which any sensations in teeth affected participants in their daily life'. It included 4 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 4 to 28. Lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from the score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	Adaptation domain of DHEQ evaluated 'the ways in which the sensations in teeth had forced participants to change things in their daily life'; 'things they did in their daily life to avoid experiencing the sensations in their teeth'. It included 12 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 12 to 84, where lower score indicated less effect of sensations on participant's daily life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's daily life).
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	Social impact domain of DHEQ evaluated 'the way the sensations affected participants when they were with other people or in certain situations.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less effect of sensations on participant's social life. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less effect of sensations on participant's social life).
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	Emotional impact domain of DHEQ evaluated 'the way the sensations in participant's teeth made them feel.' It included 8 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 8 to 56, where lower score indicated less impact of sensations on participant's emotions. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's emotions).
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	Identity domain of DHEQ evaluated 'what the sensations in participant's teeth meant for them.' It included 5 questions each scored using a 7-point scale ranging from 1 to 7 where 1=strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. Thus, the total score ranged from 5 to 35, where lower score indicated less impact of sensations on participant's identity. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's identity).
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	Global oral health was evaluated using a single question of DHEQ. Participants rated the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicated better oral health. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement in overall oral health.
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56	Baseline (Day 0), Day 28 and Day 56	Effect on life overall was evaluated using 4 questions of DHEQ about how much the sensations in teeth affected participant's life overall. Participants scored each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranged from 0 to 16, where lower score indicated less impact of sensations on participant's life overall. Change from Baseline was calculated by subtracting the Baseline (Day 0) score from score at each indicated timepoint. A negative change from Baseline indicated improvement (less impact of sensations on participant's life overall).

Trial Locations

Locations (1): Family and Cosmetic Dentistry, All Sums Research Center Ltd.
🇺🇸
Melbourne, Florida, United States
Family and Cosmetic Dentistry, All Sums Research Center Ltd.
🇺🇸Melbourne, Florida, United States