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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA. ANNEXURE II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. NAME OF THE CANDIDATE AND ADDRESS DR. CHANDRAVIR SINGH POST GRADUATE STUDENT, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, FORT BANGALORE-560002. 2. NAME OF THE INSTITUTE GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE, FORT, BANGALORE. 3. COURSE OF STUDY AND SUBJECT MASTER OF DENTAL SURGERY IN ORAL AND MAXILLOFACIAL SURGERY. 4. DATE OF ADMISSION TO COURSE 31.05.2009 5. TITLE OF THE TOPIC: “EFFICACY AND SAFETY OF AMOXICILIN + CLAVULINIC ACID IN COMPARISON WITH CEFADROXIL + CLAVULINIC ACID IN VARIOUS MAXILLOFACIAL AND MINOR ORAL SURGICAL PROCEDURES- A CLINICAL STUDY” 6. BRIEF RESUME OF THE INTENDED WORK: 6.1 NEED FOR THE STUDY: - Since the invention of the penicillin the use of antibiotics has become an integral part of surgery for prophylaxis as well as for the treatment of the active infection. Presently several antibiotics are available but amoxicillin is most widely used in maxillofacial region. Addition of a beta-lactamase inhibitor i.e. Clavulanic acid with amoxicillin has further increased its antimicrobial activity and acceptance.1 Recently combination of cephalosporins and clavulanic acid is gaining acceptance.2 However no studies have been published comparing the amoxicillin-clavulanic acid and cefadroxil-clavulanic acid in the various oral and maxillofacial surgeries and established odontogenic infections. This study has been taken up to enlighten further comparing the two drug combinations and fill this void. 1 6.2 REVIEW OF LITERATURE: 1. Topazian RG described that beta-lactams remain the mainstay for prevention and treatment of most bacterial infections of the head and neck. Amoxicillin with the clavulanic acid is the most commonly used beta lactamase inhibitor. It increases the spectrum of the drug against beta lactamase producing bacteria.1 2. Garcia-Rodriguez JA, Mufioz Bellido JL, Garcia SBnchez JE has said that in ENT infections, the most common pathogens causing acute otitis media and sinusitis are susceptible to oral cephalosporins. From a therapeutic point of view, efficacy rates of the newer oral cephalosporins, in acute otitis media are, in most studies, similar to or slightly better than amoxicillin and amoxicillin/clavulanate.2 3. According to Jacobs et al Amoxicillin is a useful agent for treating streptococcal infections, whereas amoxicillin–clavulanate is a useful agent for treating methicillinsusceptible staphylococcal infections because the addition of the beta-lactamase inhibitor, clavulanate, inhibits staphylococcal beta-lactamase. These agents diffuse readily into most body tissues and fluids. Amoxicillin– clavulanate is indicated for treatment of beta-lactamase– producing S. aureus, Escherichia coli, and Klebsiella spp. skin and soft tissue infections, and the amoxicillin component will provide coverage for streptococcal infection.3 4. Baumgartner and Xia (2003) studied antibiotic susceptibility of bacteria associated with endodontic abscesses. Antibiotics to treat endodontic infections are routinely prescribed based on previously established susceptibility tests. 98 species of bacteria was tested for antibiotic susceptibility to a panel of six antibiotics using the E-test. The antibiotics tested were penicillin V, amoxicillin, amoxicillin+CA, clindamycin, metronidazole, and clarithromycin. The amoxicillin+CA gave better results as compared to other drugs.4 2 6.3 AIM AND OBJECTIVES OF THE STUDY: The aim of the study is to compare safety and efficacy of cefadroxil-clavulanic acid According to Baumgartner 625 (500+125) versus amoxicillin-clavulanic acid 625 (500/125) in the postoperative maintenance and assessment of quality life in various oral and maxillofacial minor oral surgical procedures such as 3rd molar surgery, alveoloplasty, vestibuloplasty, and fractures of maxillofacial region which are not in the stage of active infection. OBJECTIVES:1. To compare clinical efficacy of the amoxicillin-clavulanic acid and cefadroxilclavulanic acid. 2. To evaluate the incidence of infection which may manifest as swelling, purulent discharge around the surgical site and fever. 3. Incidence of side effects like diarrhea, nausea, vomiting in the two groups. MATERIALS AND METHODS : - 7.1 SOURCES OF THE DATA. Patients visiting the Department of Oral and Maxillofacial Surgery, Government Dental college and Research Institute, fort, Bangalore. 7.2 METHODS OF COLLECTION OF DATA. Patients are selected randomly who have come for their treatment related with impacted 3rd molar (which can be managed by minor oral surgical procedures), anatomic pre-prosthetic problems, recent compound fractures which are not infected but are prone for infection ; in short all the oral surgical and maxillofacial treatment which can be managed by the oral antibiotics. Sample size is 200. INCLUSION CRITERIA: 1. Patient seeking treatment through minor oral surgery manageable through oral antibiotics. 2. Recent maxillofacial trauma. 3. Patients with odontogenic infections indicated for oral antibiotics. 3 EXCLUSION CRITERIA: 1. Patient with severe infections requiring hospitalization aggressive intravenous antibiotic therapy. 2. Patient allergic to penicillin and cephalosporin PROCEDURE: Patient fulfilling the inclusion criteria are selected randomly and divided into four groups i.e. Group 1- impaction fifty patients A. 25 patients with amoxicillin-clavulanic acid B. 25 patients with cefadroxil-clavulanic acid Group 2- fifty patients of minor oral surgical procedures A. 25 patients with amoxicillin-clavulanic acid B. 25 patients with cefadroxil-clavulanic acid Group 3- fifty patients of compound fractures A. 25 patients with amoxicillin-clavulanic acid B. 25 patients with cefadroxil-clavulanic acid Group 4- fifty patients of odontogenic infection A. 25 patients with amoxicillin-clavulanic acid B. 25 patients with cefadroxil -clavulanic acid Patients receiving amoxicillin-clavulanic acid will be given oral 625 mg t.i.d. and those receiving cefadroxil-clavulanic acids will be given 625 mg b.i.d. Patients will be given the antibiotics for a period of 7 days. Patients will be given instruction to follow the treatment protocol and to maintain health, general and oral hygiene and proper nutrition. Follow up will be done for 1,3,5,7 days during which patients are evaluated for the efficacy of the drug therapy and incidences of infection such as swelling and purulent discharge at the surgical site and side effects like nausea, vomiting and diarrhea. Further follow up will be done if necessary. Complications arising during or after the treatment will be managed accordingly. 4 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? YES 7.4 Has ethical clearance been obtained from your institution in case of 7.3? YES LIST OF REFERENCES: 1. Garcia-Rodriguez JA, Mufioz Bellido JL, Garcia SBnchez JE. Oral cephalosporins: current perspectives. International Journal of Antimicrobial Agents 1995; 5: 231-243. 2. Research review paper: Clavulanic acid: A review. Saudagar PS, Survase SA, Singhal RS Biotechnology Advances. 2008; 26: 335–351. 3. Jacobsa MR, Jonesb NR, Giordanod PA. Oral beta-lactams applied to uncomplicated infections of skin and skin structures. Diagnostic Microbiology and Infectious Disease 2007; 57: 55S–65S 4. Mitropoulosa FI, Rotschafera JC, Rodvoldb KA. Adverse events associated with the use of oral cephalosporins/cephems. Diagnostic Microbiology and Infectious Disease. 2007; 57: 67S76S 5. Richard G Topazian. Oral and maxillofacial infections-WB Saunders company. 4th edition, 2002: 112-125. 5 z SIGNATURE OF THE CANDIDATE 10. REMARKS OF THE GUIDE 11 NAME AND DESIGNATION OF 11.1 GUIDE DR. A. SIDDARAJU, ASSOCIATE PROFESSOR, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE. BANGALORE 11.2 SIGNATURE 11.3 CO-GUIDE DR. GIRISH B. GIRADDI PROFESSOR AND HEAD DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE. BANGALORE 11.4 SIGNATURE 6 11.5 HEAD OF THE DEPARTMENT DR. GIRISH GIRADDI, PROFESSOR AND HEAD, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE. 11.6 SIGNATURE 12. 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL 12.2 SIGNATURE 7