The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03072719
• Date of registration: 02/03/2017
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity
• Scientific title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity
• Date of first enrolment: March 1, 2012
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03072719
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Ireland

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion

- Demonstrates understanding of the study and willingness to participate

- Aged at least 18 to 65 years

- Understands and is willing, able and likely to comply with all study procedures and
restrictions

- Good general health with (in the opinion of the investigator) no clinically
significant and relevant abnormalities of medical history or oral examination.

- Self-reported history of dentinal hypersensitivity lasting more than 6 months but not
more than 10 years

- Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors,
canines, pre-molars)

- At baseline, participant has two non-adjacent sensitive teeth from those meeting the
EAR, GI and mobility criteria at screening, with sensitivity measured by tactile
stimulus (Yeaple = 20g) and evaporative (air) assessment (Schiff Sensitivity Score =
2) at baseline

Exclusion

- Pregnant or breast-feeding women

- 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 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

- An employee of the sponsor or the study site or members of their immediate family

- 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

- Dental prophylaxis within 4 weeks of screening

- Tongue or lip piercing or presence of dental implants

- Professional desensitising treatment within 12 weeks of screening

- 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 12 weeks of screening

- Tooth with evidence of current or recent caries, or reported treatment of decay in 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
dentifrice in the opinion of the investigator.

- Use of a desensitising dentifrice within six weeks of screening (participant will be
required to bring their current dentifrice to the site in order to verify the lack of
known anti-sensitivity ingredients)

- Daily doses of a medication which, in the opinion of the investigator, could interfere
with the perception of pain

- Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.

- Daily doses of a medication which, in the opinion of the investigator, causes
xerostomia

- Individuals who require antibiotic prophylaxis for dental procedures

- Any participant who, in the judgment of the investigator, should not participate in
the study.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dentine Hypersensitivity

Intervention(s)

Drug: Stannous Fluoride

Drug: Sodium Monofluorophosphate

Primary Outcome(s)

Change From Baseline in Schiff Sensitivity Score on Day 14 [Time Frame: Baseline, Day 14]

Secondary Outcome(s)

Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14 [Time Frame: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14]

Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3 [Time Frame: Baseline, post first brushing (after 5 minutes) and Day 3]

Secondary ID(s)

202161

RH01327

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03072719