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

Dentin Sensitivity Clinical Trial

Official title:

An 8-Week, Randomized, Controlled, Examiner-Blind, Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentin Hypersensitivity in a Population of Dentin Hypersensitivity Sufferers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06359028
• Other study ID #: 300103
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: June 20, 2024

Study information

• Verified date: April 2024
• Source: HALEON
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 a DH population. 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Est. completion date: June 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

1. 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.

2. 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 <= 20 g and a screening Schiff sensitivity score >= 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.
• 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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• Stannous fluoride toothpaste
Toothpaste containing 0.454 % weight/weight (w/w) SnF2
• Crest cavity protection toothpaste
Regular fluoride toothpaste containing 1100 parts per million (ppm) fluoride.

Locations

Country	Name	City	State
United States	Salus Research	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
HALEON

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Schiff Sensitivity Score at Day 56	Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus will be evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline will be calculated by subtracting baseline score from Day 56 score. A decrease in Schiff sensitivity score indicates an improvement.	Baseline and Day 56
Secondary	Change from Baseline in Tactile Threshold at Day 56	Tactile sensitivity will be assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in gram (g). At baseline, the upper force setting will be 20g. Tactile threshold (g) will be derived as the mean value for the two 'Test Teeth' selected by the examiner at baseline. An increase in tactile threshold indicates an improvement in sensitivity. Change from baseline will be calculated by subtracting baseline value from Day 56 value.	Baseline and Day 56
Secondary	Change from Baseline in Schiff sensitivity score at Day 28	Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus will be evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline will be calculated by subtracting baseline score from Day 28 score. A decrease in Schiff sensitivity score indicates an improvement.	Baseline and Day 28
Secondary	Change from Baseline in Tactile Threshold at Day 28	Tactile sensitivity will be assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe). The probe tip will be placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in 'g'. At baseline, the upper force setting will be 20g. Tactile threshold (g) will be derived as the mean value for the two 'Test Teeth' selected by the examiner at baseline. An increase in tactile threshold indicates an improvement in sensitivity. Change from baseline will be calculated by subtracting baseline value from Day 28 value.	Baseline and Day 28
Secondary	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	DHEQ section 1, questions 7-9 are about teeth sensation and its impact on everyday life. Participants will score 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). Thus, the total score ranges from 3 to 30; where the lower score indicates less sensitivity and less impact on everyday life. Change from baseline is defined as score at indicated post-baseline timepoints minus score at baseline.	Baseline, Day 28 and Day 56
Secondary	Change from Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56	The DHEQ is a condition-specific measure of Oral Health-related Quality of Life (OHrQoL) in relation to DH which contains total 34 questions in section 2, each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 34 to 238; where the lower score indicates improvement in the symptoms. Change from baseline is defined as score at indicated post-baseline timepoints minus score at baseline.	Baseline, Day 28 and Day 56
Secondary	Change from Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56	Restrictions domain in DHEQ evaluates the ways in which any sensations in teeth affect participant's daily life. This contains 4 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 4 to 28; where the lower score indicates improvement in the symptoms. Change from baseline is defined as score at indicated post-baseline timepoints minus score at baseline.	Baseline, Day 28 and Day 56
Secondary	Change from Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56	Adaptation domain in DHEQ evaluates 'the ways in which the sensations in teeth have forced participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. This contains 12 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 12 to 84; where lower score indicates improvement in the symptoms. Change from baseline is defined as score at indicated post-baseline timepoints minus score at baseline.	Baseline, Day 28 and Day 56
Secondary	Change from Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56	Social Impact domain in DHEQ evaluates the way the sensations affect participants when they are with other people or in certain situations. This contains 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 5 to 35; where the lower score indicates improvement in the symptoms. Change from baseline is defined as score at indicated post-baseline timepoints minus score at baseline.	Baseline, Day 28 and Day 56
Secondary	Change from Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56	Emotional Impact Domain in DHEQ evaluates the way the sensations in participant's teeth make them feel. This contains 8 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 8 to 56; where the lower score indicates improvement in the symptoms. Change from baseline is defined as score at indicated post-baseline timepoints minus score at baseline.	Baseline, Day 28 and Day 56
Secondary	Change from Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56	Identity Domain in DHEQ evaluates what the sensations in participant's teeth mean for them. This contains 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 5 to 35; where the lower score indicates improvement in the symptoms. Change from baseline is defined as score at indicated post-baseline timepoints minus score at baseline.	Baseline, Day 28 and Day 56
Secondary	Change from Baseline in Global Oral Health (Section 2, Q35) Score at Days 28 and 56	Global Oral Health will be evaluated using a single question which asks about overall health of participant's mouth, teeth, and gums. The scale ranges from 1 (excellent) to 6 (Very poor), where the lower score indicates improvement in the symptoms. Change from baseline is defined as score at indicated post-baseline timepoints minus score at baseline.	Baseline, Day 28 and Day 56
Secondary	Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Days 28 and 56	Effect on life will be evaluated using 4 questions which asks how much the sensations in teeth affect participant's life overall. The scale ranges from 0 (not at all) to 4 (Very much) and thus, the total score ranges from 0 to 16; where the lower score indicates improvement in the symptoms. Change from baseline is defined as score at indicated post-baseline timepoint minus score at baseline.	Baseline, Day 28 and Day 56