To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH)

NCT02937623 | Completed Results

• 1 other identifier: 207238
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after application compared to no treatment.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Schiff Sensitivity Score After 10 Minutes

  The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 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 reduction in Schiff Sensitivity score indicate improvement in sensitivity.

  At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study

Secondary Outcomes (3)

• Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours

  At Baseline (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the study

• Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours

  At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study

• Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours

  At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study

Study Arms (2)

Test Product: Dissolvable polymer strip containing Novamin

EXPERIMENTAL

In this arm, participants received an experimental dissolvable polymer strip containing 15 % weight/weight (w/w) calcium sodium phosphosilicate (Novamin). One strip was applied per test tooth topically by a suitably qualified member of the site staff. Each participant received 2 strips in total (as two test tooth were assessed per participant).

Device: Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)

Reference Product: No treatment/product

NO INTERVENTION

In this arm, participants did not receive any treatment/product.

Interventions

Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate) DEVICE

Experimental dissolvable polymer strip containing Novamin (15% weight by weight\[w/w\] calcium sodium phosphosilicate).

Test Product: Dissolvable polymer strip containing Novamin

Eligibility Criteria

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

You may qualify if:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received assigned and dated copy of the informed consent form.
• Aged 18-65 years.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities of medical history or oral Examination and absence of any condition that would impact on the participants safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.
• Understands and is willing, able and likely to comply with all study procedures and restrictions.
• At Visit 1 (Screening): a) Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years. b) Minimum of 20 natural teeth. c) Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), in different quadrants and separated by at least two teeth (or equivalent edentulous space), that meet all of the following criteria: Signs of facial/ cervical (i.e. labial/ buccal) gingival recession and/or signs of erosion or abrasion (EAR), tooth with MGI score = 0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1 and tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response) on the facial/ cervical (i.e. labial/ buccal) tooth surface.
• At Visit 2, Baseline (Pre-treatment): Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) in different quadrants of the mouth and separated by at least two teeth (or equivalent edentulous space), 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) on the facial/ cervical (i.e. labial/ buccal) tooth surface.

You may not qualify if:

• A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
• A women who is breast-feeding.
• 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 and previous participation in this study.
• 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 and any condition which, in the opinion of the investigator, causes xerostomia (dry mouth).
• Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing, desensitizing treatment within 8 weeks of Screening (professional sensitivity treatments and non-dentifrice 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 and teeth bleaching within 8 weeks of screening.
• Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of screening and tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, dental implants, 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 an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening (Participants will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients).
• Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs, currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline and daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
• Any participant who, in the judgment of the investigator, should not participate in the study.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Las Vegas, Nevada, 89146, United States

Location

Related Publications (1)

• Gallob J, Ling MR, Amini P, Patil A, Atassi M. Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin(R)) in providing rapid dentine hypersensitivity relief. J Dent. 2019;91S:100003. doi: 10.1016/j.jjodo.2019.100003. Epub 2019 Jun 15.

  PMID: 34059276 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 18, 2016
• Study Start: November 21, 2016
• Primary Completion: December 22, 2016
• Study Completion: December 22, 2016
• Last Updated: January 29, 2018
• Results First Posted: December 22, 2017

Record last verified: 2018-01

Locations

US (1)