Download Materials and Methods

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA
BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
Name of the Candidate and Address
DR. SANTOSH KUMAR
S/O SIDRAMAYYA MATHAPATI
H.NO.9-953/1, JANTA LAY OUT,
S.B.TEMPLE ROAD,
GULBARGA – 585 103
(KARNATAKA)
Temporary Address
POST GRADUATE STUDENT
DEPARTMENT OF ORAL &
MAXILLOFACIAL SURGERY,
AL-BADAR RURAL DENTAL COLLEGE
AND HOSPITAL,
GULBARGA – 585 102 - KARNATAKA
2.
Name of the Institution
AL-BADAR RURAL DENTAL COLLEGE
AND HOSPITAL,
GULBARGA – 585 102 – KARNATAKA
3.
Course of Study and subject
MASTER OF DENTAL SURGERY (M.D.S)
DEPARTMENT OF ORAL AND
MAXILLOFACIAL SURGERY
4.
Date of admission to Course
5.
Title of the Topic
21.04.2009
MINOR ORAL SURGERY WITHOUT
STOPPING DAILY LOW-DOSE
ANTIPLATELET THERAPY
-A Clinical Study
6.
Brief resume of the intended work
1.
6.1 Need for the study:
The fear of uncontrolled bleeding after minor oral surgical procedures in patients
who are on low-dose antiplatelet regime is always a concern. It can be either
Aspirin (Acetylsalicylic acid) or Clopidogrel (not more than 100 mg per day). This
prompts physicians and dental surgeons to stop antiplatelet drugs before surgery,
which is scientifically not substantiated. On the contrary, it may put the patients at
a risk of adverse thromboembolic events. We believe that most of the minor oral
surgical procedures can be undertaken safely without stopping these drugs.
6.2 Review of Literature:
This study in the year 2005 included a total of 51 patients undergoing minor oral
surgical procedures between May 2002 to May 2003, who were on long-term lowdose Aspirin therapy regimens (acetylsalicylic acid 75mg to 100mg/day).
Investigations such as bleeding time and platelet count were performed. If within
normal limits, Aspirin was not stopped and surgery was performed under LA. All
wounds were sutured and followed up at 24, 48, 72 hours, one week and 2 week
after the procedure. The conclusion was that most minor oral surgical procedures
can be carried out safely without stopping long-term low –dose Aspirin regimen1.
This study in the year 2000 was conducted to evaluate the effect of Aspirin on
bleeding in patients undergoing oral surgical procedures. It included 39 patients who
were scheduled to undergo dental extractions. All patients were receiving 100mg of
Aspirin daily. The authors randomly divided the patients into two groups 1) Those
who stopped the Aspirin therapy before the procedure. 2) Those who continued the
Aspirin therapy. One hour before the procedures, all patients underwent bleeding
time test. In addition, the amount of bleeding during the procedure was measured.
For first group bleeding time was (1.8+/-0.47) and for the second group, bleeding
time was (3.1+/-0.65). This study concluded by saying that low dose Aspirin therapy
need not be stopped before oral surgical procedures as local hemostasis is sufficient
to control any bleeding during surgery2.
This study in the year 2008 was conducted in 36 healthy patients requiring a single
tooth extraction. These patients were randomized to receive 325 mg Aspirin per day
or placebo for 4 days. Bleeding time and platelet aggregation test, were conducted
prior to extraction and were evaluated with the outcomes following extraction. Study
concluded that there is no indication to discontinue Aspirin for persons requiring
single tooth extraction3.
This study in the year 2008 undertook an assessment of the incidence of prolonged
post-operative bleeding after dental extractions among patients on uninterrupted
antiplatelet therapy and evaluate the need to stop such medications before dental
extractions. Total of 82 patients required dental extractions of whom 57 were on
antiplatelet therapy(Aspirin). Patients were divided into 3 groups.
Group 1 consisted of patients in whom antiplatelet therapy was interrupted (n=25),
group 2 consisted of those continuing their medication (n=32) and group 3
comprised of healthy patients not on antiplatelet therapy (n=25). Preoperative
clotting time and bleeding time were checked and one way analysis of the variance
was performed to determine the significance of prolonged bleeding among groups.
The results of the study shows that there is no significant bleeding from the
extraction sites in any of the groups. Study concluded that dental extraction can be
safely performed in patients on long term antiplatelet medication, with no
interruption or alteration of their medication, such patients do not have increased
risk of prolonged or excessive postoperative bleeding4.
This study was done in the year 1999 on 50 patients to evaluate the effects of
discontinuation of long term, low dose Aspirin prior to ambulatory oral surgical
procedures. The patients were randomly divided into test and control groups. The
patients in control group stopped taking Aspirin a week before operation, but in the
test group Aspirin was continued. Before, during and after surgery; bleeding time
was tested. Study concluded that hemostasis control posed no problem and there
were no post operative complications in either group and discontinuing low dose
Aspirin prior to elective surgery is not justified5.
6.3 Objective of the study
1. To objectively assess risks if any, in patients on low dose antiplatelet therapy for
minor oral surgical procedures.
2. To predict that these patients can be treated as normal patients.
3. To minimize the risk of thromboembolic events in these patients by the stoppage
of antiplatelet therapy.
4. Early eradication of the dental pain not only enhances patient comfort; but also it
may stabilize his medical condition.
5. To convince the treating physicians that stoppage of antiplatelet therapy is not
necessary.
6. To avoid inconvenience both to the patients and the surgeons in avoidance of
2 appointments.
7.
Materials and Methods
7.1
Source of data
Patients undergoing minor oral surgery reporting to
1) O.P.D, Oral and Maxillofacial Surgery, Al-Badar Rural Dental College,
Gulbarga.
2) Selected patients reporting to Dental O.P.D Government Hospital, Gulbarga.
3) Selected surveyed patients reporting to the primary health care centre,
Gulbarga.
Criteria for selection of subjects
Subjects involved in this study are those undergoing minor oral surgical
procedures.
7.2
Method of Collection of Data: (Including sampling procedures, if any)
This study will be conducted in Al-Badar Rural Dental College and Hospital,
Gulbarga with a sample size of 50 patients undergoing routine minor oral surgical
procedures under local anesthesia. All the patients will be subjected to preoperative
investigations like Bleeding time, Clotting time and platelet count. Postoperative
follow up will be done at 24, 48 and 72 hours, 1st and 2nd week after the procedure.
Inclusion Criteria
1) Patients in the age group of 40-75 years will be included in this study.
2) A total of 50 patients will be equally divided into 2 groups as study group and
control group.
Study group would include patients taking low dose
antiplatelet drugs not more than 100mg per day.
Exclusion Criteria
1) Patients having any acute infection at the site of surgery.
2) Patients with bleeding disorders
3) Patients having hepatic and renal dysfunction.
4) Patients on anticoagulants.
5) Patients on steroids, hormonal therapy and any drug that interacts with
antiplatelet drugs
Duration of study
This study will be done for duration of 18 months starting from January 2010
to June 2011.
7.3
Does the study require any investigation or interventions to be made on patients
or animals?
YES
7.4
Has ethical clearance been obtained from your institution (in case of 7.3)?
YES
8.
List of References
1. Madan GA, Madan SG, Madan G, Madan AD. Minor Oral Surgery without
Stopping daily low – close aspirin therapy: a study of 51 patients. J Oral
maxillofac Surg. 2005 Sep; 63(9); 1262-1265.
2. Ardekian L, Gaspar R, Peled M, Brener B, Laufer D. Does Low – dose aspirin
therapy complicate Oral Surgical Procedures? J Am Dental Assoc. 2000 Mar;
131(3); 331-335.
3. M.T.Brennan, M.A.Valerin, J.L.Noll, J.J.Napenas, M.L.Kent, P.C.Fox,
H.C.Sasser, and P.B.Lockhart. Aspirin use and Post-Operative Bleeding from
Dental Extractions. J. Dent Res 87(8): 740-744, 2008.
4. Krishnan B, Shenoy NA, Alexander M, Exodontia and Antiplatelet therapy,
J.Oral Maxillofac Surg.2008 Oct; 66(10): 2063-2066.
5. Gaspar R, Ardekian L, Brenner B, Peled M, Laufer D. Ambulatory Oral
procedures in Patients on Low – dose aspirin. Harefauls. 1999 Jan 15; 136(2);
108-10.
9.
Signature of Candidate
10. Remarks of Guide
Fear of excessive bleeding after minor oral
surgical procedures in patients taking low
dose antiplatelet drugs is unfounded. The
stoppage of above is not only unnecessary
but it may complicate the condition. I think
this study will convince both patients and
dental surgeons that stoppage of these drugs
is not needed.
11. Name and Designation of the Guide (in
block letters)
12
11.1
Guide
11.2
Signature
11.3
Co-Guide
11.4
Signature
11.5
Head of the Department
11.6
Signature
12.1
Remarks of the Chairman and
Principal
DR.PAUL V JOSEPH
MDS, FDSRCS (Edin)
READER
DEPARTMENT OF ORAL AND
MAXILLOFACIAL SURGERY
AL-BADAR RURAL DENTAL
COLLEGE AND HOSPITAL,
GULBARGA – 585 102
PH NO: 09446929958
EMAILID:
[email protected]
Dr. SYED AHMED MOHIUDDIN
MDS
PROFESSOR AND HEAD
DEPARTMENT OF ORAL AND
MAXILLOFACIAL SURGERY
AL-BADAR RURAL DENTAL
COLLEGE AND HOSPITAL,
GULBARGA – 585 102
PH NO: 09900127697
EMAIL ID: [email protected]
To stop or not to stop antiplatelet drugs
before oral surgical procedures has created
lot of confusion both in dental and medical
faculties. I hope this study will help to give
a more clear message in this area.
12.2
Signature