Status:
COMPLETED
Nobio Clinical Study - Demineralization Prevention With a New Antibacterial Restorative Composite
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Nobio Ltd.
Conditions:
Dental Caries
Denture, Partial, Removable
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 a...
Detailed Description
As a major issue in dentistry, it has been stated that two-thirds of all restorative dentistry involves the replacement of failed restorations. Secondary caries indicates a lesion developing at the ma...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04059250
Start Date
May 28 2019
End Date
March 10 2020
Last Update
March 12 2021
Active Locations (1)
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1
UCSF School of Dentistry, Preventive and Restorative Dental Sciences
San Francisco, California, United States, 94143