Download proforma for registration subject for dissertation

RAJIV GANDHI UNIVERSITY OF
HEALTH SCIENCES
BANGALORE, KARNATAKA.
MASTER OF DENTAL SURGERY (M.D.S.)
DEPARTMENT OF ORAL AND
MAXILLOFACIAL SURGERY
2009
A.E.C.S. MAARUTI COLLEGE OF DENTAL
SCIENCES & RESEARCH CENTRE,
BANGALORE.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
PROFORMA FOR REGISTRATION SUBJECT FOR DISSERTATION
1.
NAME OF THE
Dr. MADHURI.G
CANDIDATE
DEPT OF ORAL & MAXILLOFACIAL SURGERY
AND ADDRESS
A.E.C.S MAARUTI COLLEGE OF DENTAL SCIENCES AND
RESEARCH CENTRE, No 108,
TANK BUND ROAD, HULIMAVU, BANGALORE-76.
NAME OF THE
A.E.C.S MAARUTI COLLEGE OF DENTAL SCIENCES,
INSTITUTION
108, TANK BUND ROAD, HULIMAVU, BANGALORE-76.
COURSE OF STUDY AND
MASTER OF DENTAL SURGERY-
SUBJECT
ORAL AND MAXILLOFACIAL SURGERY.
4.
DATE OF ADMISSION
20.04.2009.
5.
TITLE OF THE TOPIC
“EFFECT OF SERRATIOPEPTIDASE ON PAIN, SWELLING
2.
3.
TRISMUS
AFTER
THIRD
COMPARATIVE STUDY ”
MOLAR
SURGERY
-
A
6.0 BRIEF RESUME OF THE INTENDED WORK:
6.1 NEED FOR THE STUDY
The perioperative medication during third molar surgery has been an constant area of
research towards improving patient compliance. The proteolytic enzyme like
serrapeptase have been proved to be beneficial for minimizing postoperative swelling,
but still not in regular practice. The study will be conducted in order to evaluate
synergetic effect of proteolytic enzyme with local anesthetic agent during third molar
tooth removal
6.2 REVIEW OF LITERATURE
1. G. Klein and W. Kullich(2000) conducted a study “SHORT-TERM
TREATMENT OF PAINFUL OSTEOARTHRITIS OF THE KNEE WITH ORAL
ENZYMES - A RANDOMISED, DOUBLE-BLIND STUDY VERSUS
DICLOFENAC” and concluded that that oral enzymes may be considered an
effective and safe alternative to NSAIDs such as diclofenac in the treatment of
painful gonarthritis.
2. Yakup, Özgür , Emin and Ebru Deniz(2003) conducted a study
“ COMPARISON OF THE EFFECTS OF 2 DOSES OF
METHYLPREDNISOLONE ON PAIN, SWELLING, AND TRISMUS AFTER
THIRD MOLAR SURGERY” on Twenty-six healthy patients with symmetrically
impacted mandibular third molars. To compare the effects of intravenous
administration of 1.5 mg/kg and 3 mg/kg of methylprednisolone sodium succinate
(MP) on pain, swelling, and trismus after third molar surgery. Found no clinical
benefit of the higher dose of methylprednisolone.
3. Hidemichi Yuasa and Masayuki Sugiura(2004) conducted a study “CLINICAL
POSTOPERATIVE FINDINGS AFTER REMOVAL OF IMPACTED
MANDIBULAR THIRD MOLARS: PREDICTION OF POSTOPERATIVE
FACIAL SWELLING AND PAIN BASED ON PREOPERATIVE VARIABLES”
on 153 consecutive surgical extractions of mandibular third molars. Found that the
short-term outcomes of third molar operations (swelling and pain) differ depending
on patients’ characteristics (age and sex) and preoperative index of difficulty.
4. Gary D. Slade et al(2004) conducted a study “THE IMPACT OF THIRD
MOLAR SYMPTOMS, PAIN, AND SWELLING ON ORAL HEALTH-RELATED
QUALITY OF LIFE “on 480 patients with all 4 third molars scheduled for removal
were used in the analysis.And concluded that adverse impacts on quality of life
occurred for 1 in 8 patients seeking third molar surgery, and the odds increased 3-fold
for patients who had experienced pain/swelling compared with those who were
asymptomatic.
5. M. Cemil Buyukkurt , Metin Gungormus and Omer Kaya(2006) conducted a
study “THE EFFECT OF A SINGLE DOSE PREDNISOLONE WITH AND
WITHOUT DICLOFENAC ON PAIN, TRISMUS, AND SWELLING AFTER
REMOVAL OF MANDIBULAR THIRD MOLARS” on Forty-five patients who
were to undergo surgical removal of lower third molars. to evaluate the effect of a
single intramuscular dose of prednisolone and the prednisolone-diclofenac
combination on postoperative pain, trismus, and edema after the removal of third
molars. Concluded that the combination of a single dose of prednisolone and
diclofenac is well-suited to the treatment of postoperative pain, trismus, and swelling
after dental surgical procedures.
6. T.H. Al-Khatee and Y. Nusair (2008) conducted a study “EFFECT OF THE
PROTEOLYTIC ENZYME SERRAPEPTASE ON SWELLING, PAIN AND
TRISMUS AFTER SURGICAL EXTRACTION OF MANDIBULAR THIRD
MOLARS”on twenty-four healthy individuals with symmetrically impacted
mandibular third molars underwent surgical removal in a prospective, intraindividual, randomized, double-blind, cross-over study. And found there was a
significant reduction in the extent of cheek swelling and pain intensity in the
serrapeptase group at the 2nd, 3rd and 7th postoperative days , but no significant
difference in mean maximal interincisal distance was found between the 2 groups.
6.3 OBJECTIVES OF THE STUDY
1. The objective of study is to evaluate the postoperative discomfort to the patient by
adjuvant use of proteolytic enzyme during impacted third molar surgery.
7.0
MATERIALS AND METHODS
7.1 SOURCE OF DATA
The study will be conducted on the randomly selected patients reporting to the
Department Of Oral And MaxilloFacial Surgery of AECS Maaruti College Of Dental
Sciences And Research Centre, Bangalore.
7.2 METHOD OF COLLECTION OF DATA
The study will be conducted on the randomly selected patients reporting to the
Department Of Oral & Maxillofacial Surgery AECS Maaruti College Of Dental Sciences
And Research Centre.
Patients
with bilaterally symetrical impacted mandibular third molars scheduled for
extraction and also who fulfill the inclusion criteria are selected for the study. Panoramic
radiographs will be taken to assess the third molar situation. Written informed consent
will be obtained from each patient.The data will be recorded as per Performa, which
includes a clinical, radiological and hematological examination.
7.3 METHODLOGY:
Orthopantomographic radiograms will be obtained to ensure the symmetry of the type of
impaction. Teeth will be removed in 2 sessions, 2–3 weeks apart by the same
maxillofacial surgeon,. At each session, one third-molar tooth will be removed under
local anaesthesia. Surgical extraction will be performed by the single operator using a
standardized technique. Inferior dental, lingual and buccal nerve
anaesthesia will be administered using a 2-ml solution of 2% lignocaine hydrochloride
and epinephrine 1:80 000. A triangular full-thickness mucoperiosteal flap with releasing
incision on the disto-buccal aspect of the second molar will be designed.
After buccal ostectomy the tooth is elevated and removed. The socket will be
subsequently flushed with 50 ml of normal saline, and the flap sutured with interrupted
4-0 silk sutures. All patients will receive combination of serrapeptidase tablets and
and 1000 mg paracetamol tablets after the surgical procedure on the right side and
1000 mg paracetamol tablets only on the left side. The test medication consisted of 5 mg
serratiopeptidase taken every 8 h after the operation for 7 days. All patients will be given
antibiotics. Post operative instructions will be given to all patients.
Cheek swelling, pain and trismus will be measured on the 1st, 2nd, and 7th days
postoperatively. For the facial swelling three measurements will be made between 5
reference points: tragus, soft tissue pogonion, lateral corner of the eye, angle of the
mandible, and outer corner of the mouth, preoperatively, and on the second and seventh
postoperative days. Trismus will be evaluated by measuring the distance between the
mesial-incisal corners of the upper and lower right central incisors at maximum opening
of the jaws preoperatively, on the second and seventh postoperative days. Pain will be
assessed clinically using a 10-cm-long horizontal numeric scale .
INCLUSION CRITERIA:
Patients with bilaterally symmetrical impacted mandibular third molars.
Patients above 18 – 40 years of age
EXCLUSION CRITERIA:
Patients with diabetes
Bleeding disorders
Immunocompromised conditions
History of allergy to the drugs
SAMPLE SIZE: 15 bilateral symmetrical impaction
SAMPLE DESIGN: A prospective randomized clinical trial
SAMPLING METHOD: purposive sampling
7.4 DOES THE STUDY REQUIRE ANY INVESTIGATION OR
INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS
OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY.
Yes, investigations required are:
1. Routine blood investigations
2. Intra Oral Periapical Radiograph
3.OPG
7.5 HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR
INSTITUTION ?
Yes
7.6 TRAIL TESTS DONE IF ANY ?
No
LIST OF REFERENCES
JOURNAL REFERENCES
1. T.H. Al-Khateeb, and Y. Nusair. Effect of the proteolytic enzyme serrapeptase on
swelling, pain and trismus after surgical extraction of mandibular third molars. Int
joul of oral & maxillofacial surgery 2008 Marc; 37(3): 264-268.
2. Hidemichi Yuasa , and Masayuki Sugiura. Clinical postoperative findings after
removal of impacted mandibular third molars: prediction of postoperative facial
swelling and pain based on preoperative variables. Brit joul of oral & maxillofacial
surgery 2004; 42 : 209-214.
3. Yakup , Özgür , Emin and Ebru Deniz. Comparison of the effects of 2 doses of
methylprednisolone on pain, swelling, and trismus after third molar surgery. oral
surgery,oral medicine,oral pathology, oral radiology & endodontics 2003 ; 96: 535-539.
4. M. Cemil Buyukkurt, Metin Gungormus and Omer Kaya .The Effect of a Single
Dose Prednisolone With and Without Diclofenac on Pain, Trismus, and Swelling
After Removal of Mandibular Third Molars. Jour of oral & maxillofacial surgery
2006 ; 64: 1761-1766.
5. Gary D. Slade et al. The impact of third molar symptoms, pain, and swelling on
oral health-related quality of life. J of oral & maxillofacial surgery 2004 ; 62: 11181124.
6. G. Klein1 and W. Kullich Short-Term Treatment of Painful Osteoarthritis of the
Knee with Oral Enzymes - A Randomised, Double-Blind Study versus Diclofenac.
Clin Drug Invest 2000; 19 (1): 15-23
6.
9.0 SIGNATURE OF THE
CANDIDATE
10
REMARKS OF THE GUIDE
11
NAME AND DESIGNATION
OF:
11.1 GUIDE:
RECOMMENDED
DR. GANAPATHY . K P
PROFESSOR
DEPARTMENT OF
ORAL AND MAXILLOFACIAL SURGERY
A.E.C.S MAARUTI COLLEGE OF DENTAL
SCIENCES AND RESEARCH CENTRE.
11.2 SIGNATURE:
11.3 CO- GUIDE:
11.4 SIGNATURE:
11.5 HEAD OF THE
DEPARTMENT
DR. SHYLA H.N MDS
PROFESSOR AND HOD
DEPARTMENT OF
ORAL AND MAXILLOFACIAL SURGERY
A.E.C.S MAARUTI COLLEGE OF DENTAL
SCIENCES AND RESEARCH CENTRE.
11.6 SIGNATURE
12
12.1 REMARKS OF
CHAIRMAN AND
PRINCIPAL
12.2 SIGNATURE
CONSENT FORM FOR ORAL & MAXILLOFACIAL SURGERY
Patient name:
Age/Sex:
Date:
1. My condition has been explained to me as:
2. The procedure necessary to treat the condition has been explained to me & I
understand the nature of the treatment to be:
3. I have been informed of possible alternate method of treatment (if any)
including:
I understand that these other forms of treatment or no treatment at all, are choices
that I have & the risks of those choices have been presented to me.
4. My doctor has explained to me that there are certain inherent & potential risks &
side effects associated with my proposed treatment & in this specific instance they
include, but are not limited to:
A. Post-operative discomfort & swelling that may require several days of athome recovery.
B. Prolonged or heavy bleeding that may require additional treatment.
C. Injury or damage to adjacent teeth or fillings.
D. Post-operative infection that may require additional treatment.
E. Stretching of corners of the mouth that may cause cracking or bruising, &
may heal slowly.
F. Restricted mouth opening during healing; sometimes related to swelling &
muscle soreness, & sometimes related to stress on jaw joints (TMJ),
especially when TMJ problem already exist.
G. A decision to leave a small piece of root in the jaw when its removal
would require extensive surgery or risk other complications.
H. Fracture of the jaw (usually only in more complicated extractions or
surgery).
I. Dry socket (loss of blood clot from extraction sites).
J. Allergic reactions (previously unknown) to any medications used in the
treatment.
5. It has been explained that during the course of treatment unforeseen conditions
may be revealed that may require changes in the procedures noted in paragraph 2
above. I authorize my doctor & staff to use professional judgment to perform such
additional procedures that are necessary & desirable to complete my surgery.
6. The anesthetic which will be used for my surgery is: Local Anesthesia (2%
lignocaine with or without 1:80000 Adrenaline).
7. It has been explained to me, & I fully understand, that a perfect result is not or
cannot be perfectly guaranteed.
8. I certify that I have been informed about all the above points in my own language,
& I fully understand this consent for surgery, have had my questions answered &
that all blanks were filled prior to my signature.
Patient’s (or Legal guardian’s) signature/Thumb impression
Date:
Witness’s Signature
Date:
Doctor’s Signature
Date:
CASE HISTORY PROFORMA
Name of the PatientOPD NoAgeDateSexOccupationAddress-
Chief Complaint-
History of Present Illness-
Past Medical History-
Past Dental HistoryFamily HistoryPersonal HistoryGeneral Physical ExaminationExtra Oral ExaminationIntraoral ExaminationProvisional DiagnosisInvestigations-
Radiographs advised-
Radiographic Interpretation-
Definitive Diagnosis-
Treatment Plan-
Patient’s Signature
Doctor’s signature
Date: