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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.
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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.
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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.
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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.
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SIGNATURE OF THE CANDIDATE
10.
REMARKS OF THE GUIDE
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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
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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
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