RH01897-Changes in DH plaque accumulation & gingival health over 24wks
Research type
Research Study
Full title
Study to Investigate the Effect of Changes in Dentinal Hypersensitivity on Oral Health Parameters
IRAS ID
133205
Contact name
Robert Maclure
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare
Research summary
This study will monitor changes in tooth sensitivity, plaque accumulation and gum health in participants with sensitive teeth over a 24 week period. All subjects will use a daily use anti-sensitivity toothpaste twice daily for the duration of the study period. \nThe study will be conducted in healthy subjects aged 18 to 75 inclusive, with pre-existing self-reported tooth sensitivity which will then be clinically diagnosed at the study site. \nThe research will be carried out by Intertek Clinical Research Services, a clinical research organisation, on behalf of the Sponsor (GlaxoSmithKline Consumer Healthcare).\nAssessments to be used:\n• Clinical Examiner based index involving an air stimulus. \n• Subject response to pressure, which will be administered by an examiner.\n• Subject questionnaires\n• Clinical assessments on gum inflammation. \n• Clinical assessment of plaque.\nSubjects will attend the study centre on nine occasions. The first visit will be a screening visit to determine suitability to take part.\nSubjects will then be required to attend the following visits:\n•Visit 2 - Baseline sensitivity, plaque and gum inflammation assessments\n•Visit 3,4,5,6 & 8- Sensitivity assessments\n•Visit 7 & 9 - Sensitivity assessments plus plaque and gum inflammation assessments\n
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0279
Date of REC Opinion
30 Jul 2013
REC opinion
Further Information Favourable Opinion