Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity

NCT03943095 | Completed Phase 2 Results

• 1 other identifier: 209723
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.

Conditions

Dentin Hypersensitivity; Dentin Sensitivity

Outcome Measures

Primary Outcomes (18)

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Baseline (Day 0)

  Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 millimeter (mm) coronal to the gingival margin from a distance of approximately 1 centimeter (cm).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.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. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Baseline (Day 0)

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 3

  Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. 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. 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, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 3

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 7

  Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. 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. 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, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 7

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 14

  Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. 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. 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, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 14

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 28

  Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. 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. 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, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 28

• Mean Schiff Sensitivity Score (Average of the Two Selected Test Teeth) at Day 56

  Evaporative air sensitivity was assessed on facial surfaces of eligible incisor,canine and pre-molar teeth by directing a one second application of air from a standard dental syringe held perpendicular to the tooth surface, approximately 1-2 mm coronal to the gingival margin, and from a distance of approximately 1 cm. 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. 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, and requests discontinuation of the stimulus. Score range 0-3; a decrease in Schiff sensitivity score indicates an improvement. Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 56

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Baseline (Day 0)

  Tactile sensitivity was assessed for eligible incisor,canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 gram (g) and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached.The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application,the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response).The pressure setting at which participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g).At Baseline, the maximum force was 20 g;at all subsequent visits, 80 g.If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (\>) 20 g (baseline) or \>80 g (all other visits).An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Baseline (Day 0)

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 3

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (\>) 20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 3

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 7

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (\>) 20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 7

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 14

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (\>) 20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 14

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 28

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (\>) 20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 28

• Mean Tactile Threshold (Average of the Two Selected Test Teeth) at Day 56

  Tactile sensitivity was assessed for eligible incisor, canine and pre-molar teeth using a constant pressure probe (Yeaple probe),starting at 10 g and rising in increments of 10 g until the tactile threshold or maximum force for that visit is reached. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine.After each application, the participant was asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold (g). At Baseline,the maximum force is 20 g; at all subsequent visits, 80 g. If no sensitivity was found at the upper limit,the tactile threshold is recorded as greater than (\>) 20 g (baseline) or \>80 g (all other visits). An increase in tactile threshold indicates an improvement.Mean was calculated once by selecting two test teeth which were located in different quadrants of mouth.

  Day 56

• Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)

  Number of eligible teeth were identified at screening with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.

  Baseline (Day 0)

• Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3

  Number of eligible teeth were identified at screening with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.

  Day 3

• Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7

  Number of eligible teeth were identified at screening with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.

  Day 7

• Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14

  Number of eligible teeth were identified at screening with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.

  Day 14

• Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28

  Number of eligible teeth were identified at screening with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.

  Day 28

• Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56

  Number of eligible teeth were identified at screening with Schiff sensitivity score of \>=1 (Schiff sensitivity scale: 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus). A decrease in the number of sensitive teeth indicates an improvement.

  Day 56

Secondary Outcomes (2)

• Change From Baseline in Schiff Sensitivity Score at Day 56

  Baseline (Day 0), Day 56

• Change From Baseline (Day 0) in Tactile Threshold on Day 56

  Baseline (Day 0), Day 56

Study Arms (2)

Test Dentifrice

EXPERIMENTAL

Participants will be instructed to apply a strip of dentifrice (a full brush head) containing 5 % weight by weight (w/w) potassium nitrate and 0.454% w/w stannous fluoride (1100 parts per million \[ppm\] fluoride). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and will be permitted to rinse with water post-brushing.

Other: Potassium Nitrate; Other: Stannous Fluoride

Control Dentifrice

ACTIVE COMPARATOR

Participants will be instructed to apply a strip of dentifrice (a full brush head) containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush their two selected 'test teeth' first, followed by the whole mouth for at least one timed minute, twice daily (morning and evening), and will be permitted to rinse with water post-brushing.

Other: Stannous Fluoride

Interventions

Potassium Nitrate OTHER

The test dentifrice contains 5% w/w potassium nitrate.

Test Dentifrice

Stannous Fluoride OTHER

The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).

Control Dentifrice; Test Dentifrice

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed
• Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures
• Participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history, or upon oral examination, or condition that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements
• Male participant able to father children or female participant of child-bearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment
• AT VISIT 1 (Screening): Participant must have
• a self-reported history of dentin hypersensitivity (DH) lasting more than six months but not more than 10 years
• a minimum of 20 natural teeth
• a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically diagnosed DH; each tooth must meet the following criteria:
• exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR)
• Modified Gingival Index (MGI) score = 0 adjacent to the test area (exposed dentin) only
• Clinical mobility less than or equal to (=\<) 1
• DH, as evidenced by qualifying levels of tactile and evaporative air sensitivity (tactile threshold \[=\<\] 20 gram (g); Schiff sensitivity score greater than or equal to \[\>=\] 2)
• AT VISIT 2 (Baseline):
• Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with DH, as evidenced by qualifying tactile and evaporative air sensitivity (each tooth must have a tactile threshold (=\<) 20 g and a Schiff sensitivity score (\>=) 2) at the Screening and Baseline visits

You may not qualify if:

• Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family
• Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation
• Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, oral, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study
• Participant with any condition which, in the opinion of the investigator or medically qualified designee, causes xerostomia
• Participant who is a pregnant female (as evidenced by a positive Urine Pregnancy Test \[UPT\] at Screening)
• Participant who is a breast-feeding female
• Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Participant with a recent history (within the last year) of alcohol or other substance abuse
• Participant who has participated in another tooth desensitizing treatment study within 8 weeks Screening
• Participant who has used an oral care product indicated for the relief of DH within 8 weeks of Screening (participant will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
• Participant who has had dental prophylaxis within 4 weeks of Screening
• Participant who has had a tooth bleaching procedure within 8 weeks of Screening
• Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening
• Participant who has had scaling or root planning within 3 months of Screening
• Participant with gross periodontal disease

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Mississauga, L5N 6J2, Canada

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

potassium nitrate; Tin Fluorides

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Examiner-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, 8-week, randomized, controlled, parallel design, exploratory clinical study in healthy participants with dentin hypersensitivity. Eligible participants will be stratified by the maximum Baseline Schiff sensitivity score of their two selected test teeth).

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: May 13, 2019
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: September 11, 2020
• Results First Posted: September 11, 2020

Record last verified: 2020-08

Locations

CA (1)