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

Completed

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:

Observational study model:

Not applicable

Primary completion date:

2017-03-02

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

Location

GSK Investigational Site

Ellesmere Port, Cheshire, United Kingdom, CH65 4BW

Status

Study Complete

Location

GSK Investigational Site

Widnes, Cheshire, United Kingdom, WA8 6PG

Status

Study Complete

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

Completed

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.

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