Clinical trial NCT02752958: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-04-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: This will be multicenter, non-comparative design to 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, using the DHEQ. Changes in DH will be monitored clinically over the 24 week treatment period.

Eligibility 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

Primary outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8
timeFrame: At Baseline and Week 8
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12
timeFrame: At Baseline and Week 12
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16
timeFrame: At Baseline and Week 16
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20
timeFrame: At Baseline and Week 20
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24
timeFrame: At Baseline and Week 24
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4
timeFrame: At Baseline and Week 4
measure: Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8
timeFrame: At Baseline and Week 8
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12
timeFrame: At Baseline and Week 12
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16
timeFrame: At Baseline and Week 16
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20
timeFrame: At Baseline and Week 20
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24
timeFrame: At Baseline and Week 24
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4
timeFrame: At Baseline and Week 4
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8
timeFrame: At Baseline and Week 8
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12
timeFrame: At Baseline and Week 12
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16
timeFrame: At Baseline and Week 16
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20
timeFrame: At Baseline and Week 20
measure: Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24
timeFrame: At Baseline and Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Ellesmere Port
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
city: Widnes
country: United Kingdom
facility: GSK Investigational Site
state: Cheshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Mason S, Burnett GR, Patel N, Patil A, Maclure R. Impact of toothpaste on oral health-related quality of life in people with dentine hypersensitivity. BMC Oral Health. 2019 Oct 22;19(1):226. doi: 10.1186/s12903-019-0919-x.