Status:
COMPLETED
Investigate a Varnish to Protect From Erosive Toothwear
Lead Sponsor:
Colgate Palmolive
Conditions:
Tooth Erosion
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This in-situ study will investigate on extracted teeth the protection of a re-formulated varnish containing fluoride in the same concentration as an existing approved varnish used to treat caries and ...
Eligibility Criteria
Inclusion
- Males and females, between 18-70 years of age
- Informed Consent Form signed and availability for the duration of the study
- Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study.
- Examples include heart problems, valve/hip replacements, etc);
- Willingness to provide information related to their medical history
- BEWE screen (Basic erosive wear examination) of score 2 or below (no evidence of severe tooth wear)
- Normal salivary flow
- Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking.
Exclusion
- Oral pathology, chronic disease, or a history of allergy to testing products;
- Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- Subject participating in any other clinical study;
- Subject pregnant or breastfeeding;
- Subject allergic to oral care products, personal care consumer products, or their ingredients;
- Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
- A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.;
- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm
- Five or more decayed, untreated dental sites (cavities);
- Current smokers and subjects with a history of alcohol or drug abuse;
- Dental work prevents wearing of the appliance or a reported need to wear a night guard.
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06136754
Start Date
April 8 2022
End Date
July 27 2022
Last Update
November 18 2023
Active Locations (1)
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1
King's College London
London, United Kingdom