N/A N=50 Randomized Double-blind Prevention

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

Dental Caries · Denture, Partial, Removable

Bottom Line

View on ClinicalTrials.gov: NCT04059250 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Mineral Loss ΔZ — 235; 774 vol% * μm]

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nobio composite (Device); traditional composite (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Mineral Loss ΔZ	235; 774	—

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 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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04059250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.