Nobio Clinical Study - Demineralization Prevention With a New Antibacterial Restorative Composite

Completed · Not applicable

Conditions studied: Dental Caries, Denture, Partial, Removable

In brief

Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay/caries around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings. The investigators will ask lower partial denture wearers to allow them to place a "gap model" with the Nobio-composite and enamel slab in one denture flange. In the other denture flange a gap model with a standard composite will be placed as control. In the laboratory the investigators will test with established methods for demineralization/caries prevention in the test and control enamel slabs, respectively.

Key facts

Study ID

NCT04059250

Run by

University of California, San Francisco

People needed

25

Starts

2019-05-28

Expected to finish

2020-03-10

Last updated by the study team

2021-03-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• aged between 18 and 80 years,
• have at least six natural teeth remaining and have a recent history of dental caries
• wearing lower partial denture (with replaced teeth on both sides of the mouth)
• willing to wear their denture during the night
• are in good health, of either gender
• are in good current oral health with no active caries or periodontal disease (but with a history of caries)
• have an understanding of the study
• have saliva flow within the normal range (stimulated saliva flow rate of greater than 0.7 ml/minute)
• no antibiotics for the last three months
• willing to comply with all study procedures and protocols,
• residing in San Francisco or other nearby locales with community water fluoridation (to eliminate water fluoridation as a potential confounding variable)
• able to give written consent themselves
• must be able to read and understand English
• willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research

You may not qualify if…

• subjects who have less than 6 natural teeth remaining
• subjects who have used a 5,000 ppm fluoride toothpaste in the last 6 months
• subjects who have used Chlorhexidine or any other antimicrobials (cetylpyridinium etc.) in the last 6 months
• show evidence of extremely poor oral hygiene
• subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
• taking medications that may affect the oral flora or salivary flow (e.g. antibiotic use in the past three months, drugs associated with dry mouth / xerostomia)
• other conditions that may decrease the likelihood of adhering to study protocol
• in-office fluoride treatment within the last three months
• subjects who will leave the area and are unable to complete the study

Where it is running

• UCSF School of Dentistry, Preventive and Restorative Dental Sciences — San Francisco, California, United States

Full record on ClinicalTrials.gov

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