An exploratory study to investigate early dental erosion

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: The intervention for this study, is the use of either a test or dummy toothpaste prior to an erosive challenge to assess any protective effects against enamel erosion. The erosive challenge will be in the form of a lemon fruit drink which the participants will consume over 25 minutes. The test toothpaste is a marketed fluoride toothpaste and the dummy paste contains no fluoride. For each participant, following confirmation of eligibility to participate in the study, two suitable front teeth will be selected for assessment throughout the study. Participants will be required to brush their teeth twice under supervision with their assigned toothpaste, either test or dummy, as per randomisation schedule, and once at home. They will be instructed to use a brush‐head length ribbon of toothpaste and brush their teeth in their normal manner for 1 timed minute. For the supervised brushing, participants will be required to rinse the slurry formed by brushing their teeth around their mouth for a further 30 seconds. They will then be provided with 10 ml of water to rinse out their mouth with for 10 seconds. The enamel surface of the two selected teeth will be assessed for topographical changes using a novel impression technique. Tooth impressions will be taken before the use of the toothpaste, prior to the erosive drink and at set time points following the erosive challenge. The dental impressions will be assessed and graded following SEM imaging. CONDITION: Dietary acid medicated enamel loss ; Digestive System PRIMARY OUTCOME: 1. Tooth impression grading score pre‐acid challenge (baseline) and immediately following acid challenge; 2. Tooth impression grading score pre‐acid challenge (baseline) and 2, 4 and 7 hours post acid challenge; 3. Tooth impression grading score pre‐acid challenge (baseline) and immediately following brushing with a fluoride toothpaste; 4. Salivary calcium concentration, pH and buffering ability pre‐acid challenge, following an acid challenge and 7 hours after an acid challenge SECONDARY OUTCOME: Not applicable as all endpoints are exploratory 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, abutme
Epistemonikos ID: d292e6a67bf379fa33c13c6ef2e163bba71c7411
First added on: Aug 23, 2024