Investigate a Varnish to Protect From Erosive Toothwear

NCT06136754 | Completed Phase 3

• 1 other identifier: CRO-2021-10-ETW-VN-UK-BS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Tooth Erosion

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at the end of Day 3

Study Arms (2)

Group I

ACTIVE COMPARATOR

A fluoride varnish containing 5.0% NaF w/w A fluoride free toothpaste A commercially available adult soft bristle toothbrush

Drug: Varnishes, Fluoride

Group II

EXPERIMENTAL

A fluoride free varnish A fluoride free toothpaste A commercially available adult soft bristle toothbrush

Drug: Varnishes, Fluoride

Interventions

Varnishes, Fluoride DRUG

Fluoride varnish containing 5.0% NaF

Group I; Group II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Tooth Erosion

Interventions

Fluorides, Topical

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• David Bartlett, Dr

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 18, 2023
• Study Start: April 8, 2022
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

GB (1)