A Phase 3 interventional study of Varnishes, Fluoride in Tooth Erosion, sponsored by Colgate Palmolive. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Colgate Palmolive · Phase 3, Interventional, and Prevention
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 erosion. Healthy volunteers without caries, periodontal disease or signs of erosive tooth wear and who give consent will be recruited to a cross-over blinded intervention. Custom mouthguards (splints) housing 8 sections of extracted human teeth will wear the appliance for 3 consecutive days and then repeat the study. Extracted teeth will be collected from patients needing tooth extraction for dental reasons. Their participation ceases when they donate the teeth. The teeth will be sterilised with hypochlorite for a minimum of 24 hrs and then sectioned and polished to form a 5mm x 5mm area of enamel and placed in the splint. The varnish, with and without fluoride, will be applied to the surface of the extracted teeth, allowed to dry, and then placed into the mouth of the healthy volunteers for 6 hours, after which, the varnish will be carefully removed. Overnight the splint and teeth will be kept in a clean and moist environment and replaced in the mouth the following day, again for 6 hours. Every 90 minutes, four times over the day, the splint will be removed and immersed in 1% citric acid pH 2.7 for 2 minutes. At the end of the day, 2 sections will be removed and tested in the laboratory for hardness. The splint will be reinserted in the mouth again for 6 hours during which it will be immersed in the acid again every 90 mins. At the end of the day the samples will be removed and measured using profilometry. A few weeks later the process will be repeated with either the fluoride or non-fluoride varnish, the order being randomly determined.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 24 is below the median of 33 across 33 interventional studies indexed under Tooth Erosion.
Browse Tooth Erosion studies →Colgate Palmolive is the lead sponsor of 119 studies on the registry; 13 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A fluoride varnish containing 5.0% NaF w/w A fluoride free toothpaste A commercially available adult soft bristle toothbrush
Drug: Varnishes, Fluoride
A fluoride free varnish A fluoride free toothpaste A commercially available adult soft bristle toothbrush
Drug: Varnishes, Fluoride
Fluoride varnish containing 5.0% NaF
Microhardness Measurement
On day 0 and after day 2, four polished samples will have microhardness recordings. A Knoop diamond indenter, (Struers, Duramin-1/-2) at a press load of 50 g and a press time of 15 seconds will be used for each indentation. Each sample will have 5 indentations taken 100µm apart and the values recorded on an excel spreadsheet. After day 2 the samples will be re- mounted into the splint.
Time frame: day 0 & end of Day 2
Profilometry scanning
Each sample will be scanned with a non-contacting laser profilometer (NCLP) with a 655-nm confocal laser mounted on an automatic motion system (XYRIS 2000CL, Taicaan, Southampton, UK) at the end of day 3. The laser scanner is accurate and capable of detecting changes of about 1um.
Time frame: at the end of Day 3
Ran from Apr 2022 to primary completion in Jul 2022, 3 months.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fluorides, Topical