Efficacy of Shyama Tulsi (Ocimum Sanctum Linn) Extract Impregnated with Calcium Sulphate Hemihydrate as an Alternative to Systemic Antibiotics and Painkillers Post- Extraction – Randomized Controlled Trial

The extraction of tooth is one of the most common dental procedures carried out worldwide in dental setups. Owing to the nature and environment of the procedure many dentists prescribe combination of antibiotics and analgesics postoperatively. According to Cochrane database antibiotics reduce the risk of infection in patients by 70% and dry socket by 30% , but emergence of the drug resistance is the major concern. For post-extraction pain NSAIDs are prescribed for 3-5 days. Gastric pain, mucosal erosions and ulcerations produced by NSAIDs are the major concerns regarding the dosage and type of NSAIDs . Emergence of drug resistance and undesirable side effect of certain drugs has triggered immense interest in the search of new antimicrobials and anti-inflammatory alternatives of plant origin in the form of local drug delivery mode. The most important advantage for therapeutic use of medicinal plants in various ailments is their safety besides being economical, effective and readily available. Tulsi, also referred to as "the elixir of life," is renowned for its association with longevity. In Ayurveda and Siddha medicine, various parts of the plant are utilized to prevent and treat numerous illnesses and common ailments, ranging from the common cold to headaches, coughs, influenza, earaches, fevers, colic pain, sore throats, bronchitis, asthma, hepatic diseases, malarial fever, snake bites, scorpion stings, flatulence, migraine headaches, fatigue, skin diseases, wounds, insomnia, arthritis, digestive disorders, night blindness, and diarrhea. Tulsi leaves, in particular, are valued for their positive effects on nerves and memory enhancement. Chewing Tulsi leaves is recognized for its efficacy in treating ulcers and mouth infections. Additionally, it is believed that adding a few Tulsi leaves to drinking water or food can purify and eliminate microorganisms. Holy Basil, or Tulsi, is highly regarded for its ability to boost the immune system, providing protection against a diverse range of infections caused by viruses, bacteria, fungi, and protozoa. Recent studies even suggest its potential in inhibiting the growth of HIV and carcinogenic cells. In dentistry Ocimum Sanctum Linn (Shayma tulsi) had been widely used as an antimicrobial, analgesic, anti-pyretic, anti-inflammatory and as anti-gingivitis agent. It has also shown its anticariogenic properties.The minimal inhibitory concentration (MIC) of Ocimum Sanctum Linn as antimicrobial agent was found to be 4%, 6%and 10% by Agarwal P et al., Gupta B et al., Gadiyar A et al.The variation may be due to the fact that the chemical constitutes may vary due to graphic and geographic factors, difference in the microbiological method used and variation in the solvent used to prepare the extract. In vivo 4% Ocimum Sanctum Linn had been used as dentifrices, mouthwashes and gels proving the potential use of this as antimicrobial and an analgesic in dentistry. Literature pertaining to the use of Shayma Tulsi as antimicrobial and anti-inflammatory agent post extraction has not been reported earlier till date. Human graded calcium sulphate hemihydrate was one of first bone substitutes used in orthopedics and dentistry because it is readily available, easily sterilized, inexpensive, completely and rapidly resorbable, and biocompatible. In addition, calcium sulphate hemihydrate is osteoconductive; it is not osteoinductive in itself, but in the presence of bone and/or periosteum it almost always becomes osteogenic.  In dentistry it had been widely used for periodontal defect repair, sign of augmentation, extracted socket preservation and adjunct to dental implant placement for more than two decade. Orellana et al suggested that human graded calcium sulphate hemihydrate can also act as sustainable drug delivery carrier. Therefore, the present randomised controlled trial is conceptualised as an initial step to comprehensively report the antimicrobial and analgesic effect of Shayma Tulsi (Ocimum Sanctum Linn) with Human Graded Calcium sulphate Hemihydrate as a carrier in post-extraction cases. The hypothesis behind our study is that there is no significant difference in efficacy between Shayma Tulsi extract (Ocimum Sanctum Linn) with Human Graded Calcium Sulphate Hemihydrate and conventional systemic antibiotics and painkillers post-extraction.