Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity

Dentin Sensitivity Clinical Trial

Official title:

A Clinical Study Investigating the Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542943
• Other study ID #: 204762
• Status: Completed
• Phase: N/A
• First received: September 3, 2015
• Last updated: June 27, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will investigate the longitudinal efficacy of two experimental oral rinses containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX), formulated at pH 4.5 and pH 7 respectively, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form

• Aged between 18 and 55 years inclusive

• Good general and mental health with, in the opinion of the investigator or medically qualified designee:

A. No clinically significant and relevant abnormalities in medical history or upon oral examination.

B. Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.

• Dental health

At Screening:

A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.

B. Good general oral health, with a minimum of 20 natural teeth.

C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:

• Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).

• Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of =1.

• Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).

At Baseline:

D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:

• Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple = 20g) and evaporative air assessment (Schiff Sensitivity Score = 2)

Exclusion Criteria:

• Pregnant or breast feeding women

• Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.

• Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.

• Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.

• Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.

• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.

• Any condition which, in the opinion of the investigator, causes xerostomia.

• Treatment of periodontal disease within 12 months of screening

• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.

• Recent history (within the last year) of alcohol or other substance abuse

• Dental prophylaxis within four weeks of Screening.

• Tongue or lip piercing or presence of dental implants.

• Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).

• Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.

• Teeth bleaching within eight weeks of Screening

• Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.

• Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.

• Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the investigator.

• Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening

• Individuals who require antibiotic prophylaxis for dental procedures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Device:
• Experimental Oral Rinse 1
(1.5% w/w KOX, pH 4.5)
• Experimental Oral Rinse 2
(1.5% w/w KOX, pH 7)

Other:
• Placebo Oral Rinse
(0% w/w KOX, pH 4.5)

Drug:
• Standard fluoride toothpaste
1000ppm fluoride as sodium monofluorophosphate

Locations

Country	Name	City	State
United States	GSK Investigational Site	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

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 8 weeks	The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 reduction in Schiff Sensitivity score is indicative of an improvement in sensitivity.	Baseline to 8 weeks	No
Secondary	Change from baseline in Schiff Sensitivity Score at 8 weeks	The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 reduction in Schiff Sensitivity score is indicative of an improvement in sensitivity.	Baseline to 8 weeks	No
Secondary	Change from baseline in Schiff Sensitivity Score at 4 weeks.	The examiner will assess the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: 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 reduction in Schiff Sensitivity score is indicative of an improvement in sensitivity.	Baseline to 4 weeks	No
Secondary	Change from baseline in tactile threshold at 4 weeks.	The examiner will assess the response to tactile sensitivity using a Yeaple probe which allows application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force is reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gives two consecutive 'yes' responses is recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used will be 20g; at all subsequent visits, it will be 80g.	Baseline to 4 weeks	Yes
Secondary	Change from baseline in tactile threshold at 8 weeks.	The examiner will assess the response to tactile sensitivity using a Yeaple probe which allows application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force is reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gives two consecutive 'yes' responses is recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used will be 20g; at all subsequent visits, it will be 80g.	Baseline to 8 weeks	No
Secondary	Change from baseline in visual rating scale(VRS) Score at 4 weeks	Participants will rate the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants will be asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.	Baseline to 4 weeks	Yes
Secondary	Change from baseline in visual rating scale(VRS) Score at 8 weeks	Participants will rate the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants will be asked to rate their pain on a scale of 1 ("No Pain") to 10 ("Intense Pain"). A reduction in the score is indicative of an improvement in sensitivity.	Baseline to 8 weeks	Yes