DentoClude F, a Bioactive Glass technology, which is a US FDA cleared dental device that is available only by prescription to dental providers.
Cause of Sensitivity from Micro-leakage
Micro-leakage is related to several factors:
Ageing Population + material & physiological factors
Hot or cold foods and drinks
Sweet foods and drinks
Acidic foods and drinks
DentoClude F is a dentin desensitizing agent that acts by reducing and blocking micro-leakage in the tooth restoration process. The key to its functioning are the extremely small particles of bioactive glass.
DentoClude F particle size less than 1 micron in size that allows it to penetrate and ultimately fill and seal the 1 micron dentine tubules following the acid etch step, and prior to the dentin adhesive application in the tooth restoration process. DentoClude F contains CaF2 in the Bioglass component.
The indications for use with this dental therapy is for the restorations as a desensitizing agent for the dentin surfaces by completely occluding the dentin tubules to prevent micro-leakage. The indications for therapeutic use are for direct or indirect restorations following dentin etch and prior to dentin adhesive application.
DentoClude F is targeted for the treatment for cervical erosion in Class V restorations. Clinical studies suggest Silver Nitrate leakage testing and Scanning Electron Microscopy were performed at UCSF and reported on at the 2007 IADR. UCSF test results show that both DentoClude F reduces microleakage. Additional studies demonstrated through enhanced Bond strength testing that were performed at UCSF and reported on at the 2008 AADR meeting.
Test results demonstrated that DentoCLude F does not decrease bond strengths of the restoration under the conditions tested. DentoClude F and the earlier development of Occlude were classified as a Class II Cavity Varnish, 21 CFR 872.3260 and is substantially equivalent to the Centrix product (the predicate device), D/Sense II, with 510(k) number K992629 in terms of indications for use and claims, although the technology does differ in terms of the chemistry. DentoClude F proprietary technology is a finely ground Bioglass that uses special manufacturing knw-how that can fill and block the dentin tubules.
In addition to blocking the dentin tubule with a micro-mechanical bond, it has been long known in the literature that the Bioglass can, in the aqueous presence of calcium and phosphate, form apatite to further lock out micro-leakage that may occur through the tubules.
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