Formulation and evaluation of a gel comprising an antifibrinolytic (Tranexamic Acid) in combination with an antibiotic (Doxycycline) after tooth extraction in diabetic patients - A Randomized Controlled Trial

Now a days oral health play’s major important role in overall health, well-being, and quality of life which is mainly concerned with teeth, gums, and mouth. Dental disorders have become a major issue of concern now-a-days. Wound healing is a difficult procedure that requires both repair of the wound and the restoration of the damaged tissue. The procedure can be divided into the following stages: Formation of a blood clot, Inflammation, Formation of granulation tissue, Epithelialization, Bone formation, and re-modelling. During the healing oral wounds, diabetic individuals may encounter some problems. Diabetes can interfere with the body’s normal healing processes, making it more difficult for wounds to mend completely. The present study is a comparative evaluation of a novel combination of tranexamic acid and doxycycline in a gel for local drug delivery in wound healing after tooth extraction in diabetic patients. Patients will be selected based on the inclusion criteria by first co-investigator. All the information about the study will be revealed to the patient in the language he/she understands prior to surgery (Annexure ‘A’). Helsinki declaration consent (informed written consent) forms will be signed by patients and or/or parents according to Annexure ‘C’ after receiving a detailed explanation about the experimental rationale, therapy, and possible risks associated with the treatment & study in the language (in English, Hindi, Marathi) that he/she understands. A detailed case history will be taken for all patients (Annexure ‘B’), followed by clinical examination. Fitness certificate if required will be taken from general physician, general surgeon or neurosurgeon. After extraction of the tooth the gel containing doxycycline and tranexamic acid will be given to group A patients and gel containing placebo will be given to group B patients into the socket and suturing will be done with 3-0 black silk suture and pressure pack will be given followed by post operative instructions. Patients will be recalled on intervals of day-3 and day-7 evaluated for pain, mouth opening, swelling, incidence of dry socket and saliva samples will be collected for biochemical evaluation and day 15 for wound healing.