An exploratory study to investigate early dental erosio

Completed

• Conditions: Dietary acid medicated enamel loss; Digestive System

• Registration Number: ISRCTN42909440
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-03
• Study Completion: 2015-12-18
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
2. Aged at least 18 years
3. Male or female
4. General health:
4.1. Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination
4.2. Absence of any condition that would impact the participant’s safety or wellbeing, or affect the participant’s ability to understand and follow study procedures and requirements
5. Dental health:
5.1. In the opinion of the investigator or medically qualified designee good oral health is evident
5.2. Two anterior maxillary teeth (tooth numbers 12, 11, 21 and 22 (FDI Numbering System)), without signs of toothwear or exposed dentine, facial restorations, abutments for fixed or removable partial dentures, full crowns or veneers, orthodontic bands or cracked enamel that would interfere with the study evaluations
6. Understands and is willing, able and likely to comply with all study procedures and restrictions

Exclusion Criteria

1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
2. Women who are breast-feeding
3. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
4.1. Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
4.2. Previous participation in this study
5. Recent history (within the last year) of alcohol or other substance abuse
6. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate.
7. Disease:
7.1. Presence of a disease or medication which in the opinion of the investigator, will impact on assessments (for example a condition which is causing xerostomia)
7.2. Any condition or medication that in the judgement of the Investigator that is causing Xerostomia
7.3. Diabetes mellitus
7.4. Susceptibility to acid regurgitation
7.5. Be susceptible to severe dental erosion from dietary origin
8. Dental:
8.1. Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planing within 3 months of screening
8.2. Recurrent or regular aphthous ulcers
8.3. Untreated carious lesions
8.4. Surface irregularities, discoloration due to trauma, restorations and hypo or hyperplasic areas which, in the opinion of the investigator or dental assessor, would prevent accurate impressions and grading
9. Medication:
9.1. Daily doses of a medication which, in the opinion of the investigator, could impact the assessment, for example acidic medications
9.2. Any participant who, in the opinion of the investigator or designee, should not participate in the study
10. Other conditions:
10.1. Any condition that would impact on the subject’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements
10.2. Any participant who, in the opinion of the investigator or designee, should not participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Tooth impression grading score pre-acid challenge (baseline) and immediately following acid challenge<br>2. Tooth impression grading score pre-acid challenge (baseline) and 2, 4 and 7 hours post acid challenge<br>3. Tooth impression grading score pre-acid challenge (baseline) and immediately following brushing with a fluoride toothpaste<br>4. Salivary calcium concentration, pH and buffering ability pre-acid challenge, following an acid challenge and 7 hours after an acid challenge

Secondary Outcome Measures

Name	Time	Method
ot applicable as all endpoints are exploratory