Evaluation of a novel bilayer film loaded with ornidazole and ofloxacin for the treatment of patients with moderate periodontitis – A randomized controlled trial

• Periodontitis is the most common and a major public health problem due to its high prevalence (25% to 55%) worldwide, and also because it leads to tooth loss, and degrades the quality of life.  Periodontal therapy includes both mechanical and chemical therapeutic agents which help in the reduction or elimination of microbial biofilm.1

• Conventional plaque control methods like ultrasonic scaling and root planing [SRP] has reduced effectiveness because it lacks accessibility to micro-organisms in the sub-gingival environment. The administrations of systemic antimicrobial drugs have failed to achieve the adequate concentration at the required sites and its frequent usage has led to bacterial resistance.1

• Local drug delivery systems prove beneficial because of their ability to reach the base of the periodontal pocket and also cause sustained release of short dose of drug over a long period of time. It has shown promising results in mild and moderate chronic periodontitis. Among these, bilayer film incorporated with antimicrobial agents is a promising approach to treat periodontitis due to its muco-adhesivity, biodegradability, biocompatibility, non-toxicity, controllability of drug release, and easy insertion into the target place.2

• Bilayer films are the drug delivery system that contain more than one active pharmaceutical agent in a double layered polymeric film. They are gaining preference over single layer films as they offer a combination of unique properties of all substrates, which is often advantageous. Bilayer films can be made as mucoadhesive films by using mucoadhesive polymers with the added advantage of incorporating a sustained drug release layer and an immediate drug release.3

• Ofloxacin is a fluorinated carboxy quinolone exhibiting a marked bactericidal effect by inhibiting DNA gyrase. In vitro studies on bactericidal activity have suggested that ofloxacin is likely to be the most useful drug in the treatment and prevention of periodontitis. It is a synthetic broad-spectrum antimicrobial agent for oral administration.4

• Ornidazole is an antibiotic used for the treatment of anaerobic infections. As anaerobic bacteria are believed to be the predominant causative factor in periodontitis it is used in the treatment of chronic periodontitis. It acts by inhibiting DNA synthesis. It works on the principle that inactive form passively diffuses into cell where it is activated by chemical reduction. The nitro group gets reduced into anion radicals which causes oxidation of DNA leading to strand breakage and cell death. Hence, it has both antimicrobial and mutagenic effects.5

 There have been no reported clinical studies using a bilayer film containing ofloxacin, ornidazole and as a local drug delivery agent in periodontitis. Hence, the present study aims at formulation, optimization and evaluation of a bilayer film combining ofloxacin and ornidazole for the treatment of patients diagnosed with moderate periodontitis.