Karnataka two dental surgeons have developed a Novel Drug Delivery System using Carbomer as a drug for treating Dentinal Hypersensitivity. The dental surgeons, Dr Sunil S and Dr Natesh K S have received an Indian patent No. 863/MA 21/11/200, January 2006 for the process which has proved to provide faster relief in a single application.
Now the dental surgeons are scouting for pharma dental research companies to using the findings to provide a commercially viable product. The leading pharma companies with a dental product line-up include Dr. Reddy's, Micro Labs, Warren and IPCA.
The NDDS is a bio-adhesive pellet system which showed ease of application, lower drug concentrations, increased contact time of the agent with the affected site and fast relief from symptoms. The drug release into the saliva was also minimal due to the hydrophobic barrier system which reduced the solubility of the pellets. These pellets did not interfere with eating, drinking or any other daily activities. The findings also attributed to gradual and sustained release of the desensitizing agents from the novel bio-adhesive system and also its prolonged retention on the tooth surfaces.
Globally, the incidence of Dentinal Hypersensitivity is one in every two patients. It is commonly caused by loss of tooth material with wrong brushing practices, excessive consumption of carbonated drinks and grinding of teeth. Other reasons include induced acid regurgitation, early stages of dental caries, dental enamel anomalies like calcification and irregular follow-ups for orthodontist treatments.
There two existing agents to treat dentinal hypersensitivity was proving to be effective only after two to three weeks with repeated applications. Dental-scientists were on the look out for a faster relief with fewer applications.
Research by the two dental surgeons in Karnataka which spanned over three years helped to develop a NDDS using a bio-adhesive pellet in the treatment of dentinal hypersensitivity.
A clinical evaluation was conducted using the bio adhesive pellet to compare 4 per cent Strontium chloride (group A), 10 per cent Potassium oxalate (group B) with a placebo control (group C). The effects of 4 per cent Strontium chloride, 10 per cent Potassium oxalate bioadhesive pellets observed in this study, when compared with the results obtained from other studies conducted using toothpastes or mouthwashes of same agents showed that the reduction in hypersensitivity achieved in the latter was much slower in time.
The double blind randomized placebo controlled clinical trial of 6 weeks duration comprised of 30 patients & 70 sites (teeth).
Using repeated measures ANOVA test with 24 hour, 2 and 6 week values as dependent variables and baseline values as covariates, the overall sensitivity score, probe score, probe intensity score and cold air intensity score tests demonstrated a significant difference between groups and a significant difference over the 6 week study period. This clinical study was well supported by the outcome of in vitro studies, which were conducted using polarized microscope, scanning electron microscope and x-ray microanalysis.
The in vitro study findings strongly support the clinical results and confirmed the utility of bio-adhesive pellet in the treatment of dentinal hypersensitivity. The studies showed positive changes in patients.