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Trial record 6 of 32 for:    FLUORIDE ION AND NITRATE ION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943095
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Dentin Hypersensitivity Dentin Sensitivity Other: Potassium Nitrate Other: Stannous Fluoride Phase 2

Detailed Description:
This will be a single center, 8-week, randomized, controlled, examiner-blind, two treatment arm, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two selected test teeth), Phase II, exploratory clinical study in healthy participants with DH. It is hypothesized that the combination of two antisensitivity active ingredients with complementary modes of action (potassium nitrate: nerve desensitization; stannous fluoride: dentin tubule occlusion) will deliver superior anti-sensitivity efficacy, compared to either active alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Examiner-Blind
Primary Purpose: Treatment
Official Title: Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hypersensitivity
Estimated Study Start Date : May 13, 2019
Estimated Primary Completion Date : August 28, 2019
Estimated Study Completion Date : August 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Potassium

Arm Intervention/treatment
Experimental: Test Dentifrice
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
The test dentifrice contains 5% w/w potassium nitrate.

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

Active Comparator: Control Dentifrice
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
The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).




Primary Outcome Measures :
  1. Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Baseline (Day 0) [ Time Frame: Baseline (Day 0) ]
    Evaporative air sensitivity will be assessed on the 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-millimeter (mm) coronal to the gingival margin, and from a distance of approximately 1 centimeter (cm). Participant response to the stimulus is evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 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 Schiff sensitivity score indicates an improvement.

  2. Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 3 [ Time Frame: Day 3 ]
    Evaporative air sensitivity will be assessed on the 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 is evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 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 Schiff sensitivity score indicates an improvement.

  3. Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 7 [ Time Frame: Day 7 ]
    Evaporative air sensitivity will be assessed on the 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 is evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 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 Schiff sensitivity score indicates an improvement.

  4. Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 14 [ Time Frame: Day 14 ]
    Evaporative air sensitivity will be assessed on the 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 is evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 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 Schiff sensitivity score indicates an improvement.

  5. Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 28 [ Time Frame: Day 28 ]
    Evaporative air sensitivity will be assessed on the 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 is evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 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 Schiff sensitivity score indicates an improvement.

  6. Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 56 [ Time Frame: Day 56 ]
    Evaporative air sensitivity will be assessed on the 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 is evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative air stimulus. 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 Schiff sensitivity score indicates an improvement.

  7. Mean Tactile Threshold (Average of the two Selected Test Teeth) at Baseline (Day 0) [ Time Frame: Baseline (Day 0) ]
    Tactile sensitivity will be 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 10g until the tactile threshold or maximum force for that visit is reached. The probe tip is placed perpendicular to the facial surface of the tooth and drawn slowly across the exposed dentine. After each application, the participant is asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gives two consecutive 'yes' responses is recorded as the tactile threshold (g). At Baseline, the maximum force is 20g; at all subsequent visits, 80g. If no sensitivity is 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.

  8. Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 3 [ Time Frame: Day 3 ]
    Tactile sensitivity will be 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 10g until the tactile threshold or maximum force for that visit is reached. The probe tip is placed perpendicular to the facial surface of the tooth and drawn slowly across the exposed dentine. After each application, the participant is asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gives two consecutive 'yes' responses is recorded as the tactile threshold (g). At Baseline, the maximum force is 20g; at all subsequent visits, 80g. If no sensitivity is found at the upper limit, the tactile threshold is recorded as >20 g (Baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.

  9. Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 7 [ Time Frame: Day 7 ]
    Tactile sensitivity will be 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 10g until the tactile threshold or maximum force for that visit is reached. The probe tip is placed perpendicular to the facial surface of the tooth and drawn slowly across the exposed dentine. After each application, the participant is asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gives two consecutive 'yes' responses is recorded as the tactile threshold (g). At Baseline, the maximum force is 20g; at all subsequent visits, 80g. If no sensitivity is found at the upper limit, the tactile threshold is recorded as >20 g (Baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.

  10. Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 14 [ Time Frame: Day 14 ]
    Tactile sensitivity will be 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 10g until the tactile threshold or maximum force for that visit is reached. The probe tip is placed perpendicular to the facial surface of the tooth and drawn slowly across the exposed dentine. After each application, the participant is asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gives two consecutive 'yes' responses is recorded as the tactile threshold (g). At Baseline, the maximum force is 20g; at all subsequent visits, 80g. If no sensitivity is found at the upper limit, the tactile threshold is recorded as >20 g (Baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.

  11. Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 28 [ Time Frame: Day 28 ]
    Tactile sensitivity will be 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 10g until the tactile threshold or maximum force for that visit is reached. The probe tip is placed perpendicular to the facial surface of the tooth and drawn slowly across the exposed dentine. After each application, the participant is asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gives two consecutive 'yes' responses is recorded as the tactile threshold (g). At Baseline, the maximum force is 20g; at all subsequent visits, 80g. If no sensitivity is found at the upper limit, the tactile threshold is recorded as >20 g (Baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.

  12. Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 56 [ Time Frame: Day 56 ]
    Tactile sensitivity will be 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 10g until the tactile threshold or maximum force for that visit is reached. The probe tip is placed perpendicular to the facial surface of the tooth and drawn slowly across the exposed dentine. After each application, the participant is asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gives two consecutive 'yes' responses is recorded as the tactile threshold (g). At Baseline, the maximum force is 20g; at all subsequent visits, 80g. If no sensitivity is found at the upper limit, the tactile threshold is recorded as >20 g (Baseline) or >80 g (all other visits). An increase in tactile threshold indicates an improvement.

  13. Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline) [ Time Frame: Baseline (Day 0) ]
    Number of eligible teeth 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.

  14. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3 [ Time Frame: Day 3 ]
    Number of eligible teeth 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.

  15. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7 [ Time Frame: Day 7 ]
    Number of eligible teeth 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.

  16. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14 [ Time Frame: Day 14 ]
    Number of eligible teeth 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.

  17. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28 [ Time Frame: Day 28 ]
    Number of eligible teeth 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.

  18. Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56 [ Time Frame: Day 56 ]
    Number of eligible teeth 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.


Secondary Outcome Measures :
  1. Change from Baseline in Schiff Sensitivity Score at Day 56 [ Time Frame: Baseline (Day 0), Day 56 ]
    Evaporative air sensitivity will be assessed on facial surfaces of eligible incisor, canine and pre-molar teeth by directing 1 second application of air from standard dental syringe held perpendicular to tooth surface, approximately 1-2 mm coronal to gingival margin, and from a distance of approximately 1 cm. Participant response to stimulus is evaluated using Schiff sensitivity scale, examiner-based index scored immediately following administration of evaporative air stimulus. 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 stimulus. Change from baseline is calculated for individual teeth first before calculating average change for two test teeth. Decrease in Schiff sensitivity score indicates improvement.

  2. Change From Baseline (Day 0) in Tactile Threshold on Day 56 [ Time Frame: Baseline (Day 0), Day 56 ]
    Tactile sensitivity will be 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 10g until tactile threshold or maximum force for that visit is reached. The probe tip is placed perpendicular to facial surface of the tooth and drawn slowly across exposed dentine. After each application, participant is asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting at which the participant gives two consecutive 'yes' responses is recorded as the tactile threshold (g). At Baseline, the maximum force is 20g; at all subsequent visits, 80g. If no sensitivity is found at the upper limit, the tactile threshold is recorded as >20 g (Baseline) or >80 g (all other visits). Change from Baseline is calculated for the individual teeth first before calculating the average change for the two test teeth. An increase in tactile threshold indicates an improvement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

    1. a self-reported history of dentin hypersensitivity (DH) lasting more than six months but not more than 10 years
    2. a minimum of 20 natural teeth
    3. 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

Exclusion Criteria:

  • 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
  • Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy
  • Participant with a tongue or lip piercing or presence of multiple dental implants
  • Participant with fixed or removable partial dentures
  • 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 or recent caries or reported treatment of decay within 12 months of Screening
    2. Tooth with exposed dentin but with deep, defective or facial restorations
    3. Tooth with full crown or veneer
    4. Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentin
    5. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
  • Participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with the perception of pain (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs)
  • AT VISIT 1 (Screening):

Participant who has taken antibiotics in the 2 weeks prior to the Screening visit

- AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the Baseline visit, during the acclimatization period

  • Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia
  • Participant who requires antibiotic prophylaxis for dental procedures
  • Participant who 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943095


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Canada
GSK Investigational Site Not yet recruiting
Mississauga, Canada, L5N 6J2
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03943095     History of Changes
Other Study ID Numbers: 209723
209723 ( Other Identifier: GlaxoSmithKline )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Fluorides
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs