Last updated: 06/26/2019 03:50:12
To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief from Dentinal Hypersensitivity
Trial description: This single centre study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in Schiff sensitivity score on Day 3
Timeframe: Baseline and Day 3
Secondary outcomes:
Change from baseline in tactile threshold on Day 3
Timeframe: Baseline and Day 3
Change from baseline in Schiff sensitivity score after a single use
Timeframe: Baseline to 60 seconds post first treatment
Change from baseline in tactile threshold after a single use
Timeframe: Baseline to 60 seconds post first treatment
Interventions:
Enrollment:
197
Primary completion date:
2016-16-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Creeth J, Gallob J, Sufi F, Qaqish J, Gomez-Pereira P, Budhawant C, Goyal C. Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief. BMC Oral Health. 2019 Jun 4;19(1):98. doi: 10.1186/s12903-019-0781-x. PMID:31164116
Medical condition
Dentin Sensitivity
Product
SKF46655, SKF46656, sodium fluoride
Collaborators
Not applicable
Study date(s)
October 2016 to December 2016
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study 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 18-65 years.
- A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
- A woman who is breast-feeding.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study 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 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): Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years; Minimum of 20 natural teeth; 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 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 Visit 2, Baseline (Pre-treatment): 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:
- A woman who is known to be pregnant or who are intending to become pregnant over the duration of the study.
- A woman 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, previous participation in this study and any participant who was randomised for inclusion in study 205710
- 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.
- 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 vital 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, 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 and 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 andanti-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.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2016-16-12
Actual study completion date
2016-16-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief
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