Last updated: 11/20/2019 06:40:23

Impact of Long Term Management of Dentine Hypersensitivity (DH) with a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health

GSK study ID
204930
See study documents
Clinicaltrials.gov ID
NCT02752958
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Study to Investigate the Impact on Oral Health Related Quality of Life of Managing Dentine Hypersensitivity with a Daily Use Anti-Sensitivity Toothpaste
Trial description: This multicentre, non-comparative design study will monitor the impact of long term management of DH with daily use of a sensitivity toothpaste on the quality of life of a population of sensitivity sufferers. Changes in oral health related quality of life will be monitored using the Dentine Hypersensitivity Experience Questionnaire (DHEQ). The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
Single (Investigator)
Allocation:
Not applicable
Primary outcomes:

Change from baseline in mean total score (34 item total from section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4

Timeframe: At Baseline and Week 4

Change from baseline in mean total score (34 item total from section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in mean total score (34 item total from section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12

Timeframe: At Baseline and Week 12

Change from baseline in mean total score (34 item total from section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16

Timeframe: At Baseline and Week 16

Change from baseline in mean total score (34 item total from section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20

Timeframe: At Baseline and Week 20

Change from baseline in mean total score (34 item total from section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean DHEQ Score of Domain - Restrictions (4 item total from Section 2 questions 1 to 4) at Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean DHEQ Score of Domain - Restrictions (4 item total from Section 2 questions 1 to 4) at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean DHEQ Score of Domain - Restrictions (4 item total from Section 2 questions 1 to 4) at Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean DHEQ Score of Domain - Restrictions (4 item total from Section 2 questions 1 to 4) at Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean DHEQ Score of Domain - Restrictions (4 item total from Section 2 questions 1 to 4) at Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean DHEQ Score of Domain - Restrictions (4 item total from Section 2 questions 1 to 4) at Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean DHEQ Score of Domain - Adaptation (12 item total from Section 2 questions 5 to 16) at Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean DHEQ Score of Domain - Adaptation (12 item total from Section 2 questions 5 to 16) at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean DHEQ Score of Domain - Adaptation (12 item total from Section 2 questions 5 to 16) at Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean DHEQ Score of Domain - Adaptation (12 item total from Section 2 questions 5 to 16) at Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean DHEQ Score of Domain - Adaptation (12 item total from Section 2 questions 5 to 16) at Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean DHEQ Score of Domain - Adaptation (12 item total from Section 2 questions 5 to 16) at Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean DHEQ Score of Domain - Social Impact (5 item total from Section 2 questions 17 to 21) at Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean DHEQ Score of Domain - Social Impact (5 item total from Section 2 questions 17 to 21) at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean DHEQ Score of Domain - Social Impact (5 item total from Section 2 questions 17 to 21) at Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean DHEQ Score of Domain - Social Impact (5 item total from Section 2 questions 17 to 21) at Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean DHEQ Score of Domain - Social Impact (5 item total from Section 2 questions 17 to 21) at Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean DHEQ Score of Domain - Social Impact (5 item total from Section 2 questions 17 to 21) at Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean DHEQ Score of Domain - Emotional Impact (8 item total from Section 2 questions 22 to 29) at Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean DHEQ Score of Domain - Emotional Impact (8 item total from Section 2 questions 22 to 29) at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean DHEQ Score of Domain - Emotional Impact (8 item total from Section 2 questions 22 to 29) at Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean DHEQ Score of Domain - Emotional Impact (8 item total from Section 2 questions 22 to 29) at Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean DHEQ Score of Domain - Emotional Impact (8 item total from Section 2 questions 22 to 29) at Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean DHEQ Score of Domain - Emotional Impact (8 item total from Section 2 questions 22 to 29) at Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean DHEQ Score of Domain - Identity (5 item total from Section 2 questions 30 to 34) at Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean DHEQ Score of Domain - Identity (5 item total from Section 2 questions 30 to 34) at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean DHEQ Score of Domain - Identity (5 item total from Section 2 questions 30 to 34) at Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean DHEQ Score of Domain - Identity (5 item total from Section 2 questi 30 to 34) at Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean DHEQ Score of Domain - Identity (5 item total from Section 2 questions 30 to 34) at Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean DHEQ Score of Domain - Identity (5 item total from Section 2 questions 30 to 34) at Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean DHEQ Score of Domain - Global oral health rating (response to Section 2 question 35) at Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean DHEQ Score of Domain - Global oral health rating (response to Section 2 question 35) at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean DHEQ Score of Domain - Global oral health rating (response to Section 2 question 35) at Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean DHEQ Score of Domain - Global oral health rating (response to Section 2 question 35) at Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean DHEQ Score of Domain - Global oral health rating (response to Section 2 question 35) at Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean DHEQ Score of Domain - Global oral health rating (response to Section 2 question 35) at Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 item total from Section 2 questions 36 to 39) at Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 item total from Section 2 questions 36 to 39) at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 item total from Section 2 questions 36 to 39) at Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 item total from Section 2 questions 36 to 39) at Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 item total from Section 2 questions 36 to 39) at Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 item total from Section 2 questions 36 to 39) at Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 – Question (Q) No. 7 At Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 7 At Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean Score DHEQ Section1 – Question (Q) No. 8 At Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week20

Timeframe: At Baseline and Week 20

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 8 At Week 24

Timeframe: At Baseline and Week 24

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 4

Timeframe: At Baseline and Week 4

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 at Week 8

Timeframe: At Baseline and Week 8

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 12

Timeframe: At Baseline and Week 12

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 16

Timeframe: At Baseline and Week 16

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 20

Timeframe: At Baseline and Week 20

Change from baseline in Mean Score of DHEQ Section1 – Question (Q) No. 9 At Week 24

Timeframe: At Baseline and Week 24

Secondary outcomes:
Not applicable
Interventions:
  • Drug: stannous fluoride
    • Enrollment:
    75
    Primary completion date:
    2017-03-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dentin Sensitivity
    Product
    sodium monofluorophosphate, stannous fluoride
    Collaborators
    Not applicable
    Study date(s)
    May 2016 to February 2017
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 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 ofthe informed consent form
    • Aged 18-55 years
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
    • Women who are 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 ofthe informed consent form
    • Aged 18-55 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 participant's 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 his 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 [Lobene, 1986] and a clinical mobility of ≤1 Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response)
    • At Visit 2 (Baseline): Minimum of two, non-adjacent accessible teeth (incisors, canines, premolars), that meet all of the following criteria: with signs of sensitivity, measured by a qualifying evaporative air assessment (Schiff Sensitivity Score ≥ 2)
    Exclusion criteria:
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
    • Women who are 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
    • Dental prophylaxis within 4 weeks of Screening, tongue or lip piercing or presence of dental implants, 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, 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 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, tranquilizers, 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ellesmere Port, Cheshire, United Kingdom, CH65 4BW
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Widnes, Cheshire, United Kingdom, WA8 6PG
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    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
    2017-03-02
    Actual study completion date
    2017-03-02

    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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