Proforma for the registration of subjects for dissertation



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE. KARNATAKA.

ANNEXURE-I

PROFORMA FOR THE REGISTRATION OF SUBJECTS FOR DISSERTATION


1.

Name of the Candidate and address

( In Block letters)

DR. BONDU LAKSHMI HIMA BINDU

“ATHIRA”, 903-904/1, 7TH MAIN,

RAGHAVENDRA BLK,

SRINAGAR


BANGALORE- 560050

2.

Name of the Institution

M.S. RAMAIAH DENTAL COLLEGE AND HOSPITAL,

BANGALORE.

KARNATAKA.


3.

Course of study and Subject

MASTER OF DENTAL SURGERY (M.D.S) IN ORAL AND MAXILLOFACIAL SURGERY.

4.

Date of Admission to Course

22ND APRIL 2009



5.

Title of the Topic

“COMPARISON OF THE ANAESTHETIC EFFICACY OF 4% ARTICAINE AND 2% LIGNOCAINE IN MINOR ORAL SURGERY: A RANDOMISED CONTROLLED TRIAL”






6.

BRIEF RESUME OF WORK

6.1




NEED FOR THE STUDY

Pain control in minor oral surgery involves effective use of local anaesthetic drugs. Lignocaine, presently is the most widely used local anaesthetic for pain control and is considered as the gold standard for comparison with other local anaesthetics. However, certain drawbacks exist like limited diffusability necessitating multiple injections. In addition lignocaine being an amide derivative is metabolised in the liver and is contraindicated in patients with liver dysfunction. Articaine is one of the newer local anaesthetics, with properties different than the conventional agents of the amide group. Though used widely in Europe and Canada, it is still relatively new in India and its use in our country in minor oral surgical procedures is not well documented. The purpose of this study is to evaluate the efficacy of 4% articaine in comparison with 2% lignocaine (both in 1:200,000 adrenaline) in minor oral surgery.






6.2

REVIEW OF THE LITERATURE



Lidocaine hydrochloride has maintained its status as the most widely used local

anesthetic in dentistry since its introduction. Proven efficacy, low allergenicity, and

minimal toxicity through clinical use and research have confirmed the value and safety of

this drug.

Articaine hydrochloride was synthesized by Rusching et al in 1969 and first marketed in Germany in 1976. It has the unique pharmacological property of being an amide anaesthetic with a thiophene ring containing methyl ester side linkage that increases its lipid solubility as well as its potency. And being the only amide anaesthetic with an ester linkage allows it to be metabolized both by plasma esterases and liver microsomal enzymes.

Malamed et al after comparing the drug efficacy of 4% articaine with 2% lignocaine (both with adrenaline 1:100,000) reported articaine to be safe local anaethestic that can be used both in children and in adults1.

Several studies have reported that Articaine demonstrates certain clinical advantages over other local anaesthetics. It is considered to be 1.5 times more potent than lignocaine2. A recent clinical trial conducted by Rebolledo et al3 on 30 patients with bilateral surgical extraction of symmetrical third molars showed statistically significant results in mean duration of the anaesthetic effect between the two (220.86 min for 4% articaine vs 168.20 min for 2 % lignocaine).

In the same study latency, the amount of anaesthetic solution used and the need to re anaesthetize the surgical field also showed clinical differences in favour of articaine, though statistical significance was not reached.


It is considered that articaine has superior diffusion through bony tissues in

comparison to lignocaine, owing to its thiophene ring. A clinical trial conducted by Fan et al4 on 71 patients requiring removal of bilateral symmetric maxillary teeth concluded that the routine use of a palatal injection for the removal of permanent maxillary teeth may not be required when articaine HCl is used as the local anaesthetic, due its superior diffusion.

. This is consistent with the findings of studies by Uckan et al5 and Oertel et al6

where they established this property of articaine.

In contrast studies conducted by others like Malamed et al7 in 2000 and Mikesell et al8 in 2005 no significant differences in anaesthetic efficacy between the two.






6.3

Objectives of the study:






  1. To compare the efficacy of 4% articaine with 2% lignocaine (both with

adrenaline 1:200,000) in minor oral surgery.

  1. To compare the pain experienced by the patient during surgery using

Visual Analog Scale (VAS).




7. Materials and methods

7.1 Source of the data

Department of Oral and Maxillofacial surgery, M.S.Ramaiah Dental College &

Hospital, Bangalore.

Sample size : 51 patients requiring extractions of molars and surgical extraction of

third molars will be included in each group.

The sample size is estimated based on the study –Rebolledo AS, Molina ED,

Aytes LB, Escoda CG. Comparative study of anaesthetic efficacy of 4% articaine

versus 2% lidocaine in inferior alveolar nerve block during surgical extraction of

impacted lower third molars. Med Oral Patol Oral Cir Buccal 2007;12:139-144.

Considering the duration of anaesthesia from the study in Lignocaine group

(168.2 ± 10.77 SD) and Articaine group (220.8 ±13.81) and the precision as 5% α

error and 10% β error with minimum expected difference between group L and group

A as 8 minutes the above mentioned sample size was determined.

Type of study: Double Blind Randomized controlled trial.













Inclusion criteria:

1. Patients requiring simple or trans alveolar extraction of firm molars.

2. Patients with impacted third molars.

Exclusion criteria:


  1. Subjects with any systemic diseases or previous history of complications

associated with local anaesthetic administration.

  1. Presence of acute infection or swelling.

  2. Patients allergic to the local anaesthetics.






Methodology:

102 patients requiring minor oral surgery, visiting the Department of Oral and

Maxillofacial surgery will be included in the study. They will be will be allocated into either

of the two study groups using the appropriate methods of randomisation.

Study group 1: This will consist of patients who will receive 2% lignocaine HCl as the

local anaesthetic.



Study group 2:

a. This will consist of patients who will receive 4% articaine HCl as the local

anaesthetic.

b. In this group patients undergoing procedures involving maxillary teeth will

receive only buccal infiltration and an additional palatal injection will be given only if

required.



  1. Patient will be included in the study after recording detailed health history, clinical and radiographic examination.

  2. After obtaining the informed consent, each patient will be randomly allocated using to either of the study groups.

  3. Surgery will be performed on each patient using either 4% articaine or 2% lignocaine

( both using 1:200,000 adrenaline).

  1. Following the surgery the standard post operative instructions will be given to the patients along with the antibiotics and analgesics as and when required.



7.2 METHOD OF COLLECTION OF DATA :

The local aesthetics used in this trial will be evaluated for the following :



  1. The total volume of the anaesthetic solution (in ml) used.



  1. The onset of the anaesthetic action (in minutes) – This will be calculated from the point

of needle withdrawal from the site of the injection to the time of the appearance of the

subjective symptoms.



  1. The quality of anaesthesia during the surgery as evaluated by the surgeon.

This is based on three point category rating scale –

1= no discomfort reported by the patient during surgery,

2= any discomfort reported by the patient during surgery,

3= any discomfort reported by the patient during surgery requiring additional

anaesthesia.


  1. Duration of the surgery (in minutes).

Corresponding to the period between first incision to last suture







  1. Duration of post operative anaesthesia.

- Represented by lack of sensation of the mucosa, tongue or inferior lip.

- Patients will record the moment that all soft tissue sensation returns to normal.

f. Subjective pain evaluation using VAS.

The pain evaluation will be done by the patient using Visual Analog Scale (VAS). The

VAS will be composed of an unmarked, continuous, horizontal, 100-mm line, anchored by

the end points of “no pain” on the right and “worst pain” on the left.






Statistical tests:

Independant t test will be employed to compare the amount of anaesthetic solution used, latency, mean duration of anaesthesia and duration of the surgery between lignocaine and atricaine groups.

7.3 Does this study require any investigation or interventions to be conducted on patients or other humans or animals?

1. IOPAR

2. OPG


7.4 Has ethical clearance been obtained from your institution in case of the above?

Yes






8. List of References:

  1. Malamed SF, Gagnon S, Leblanc D. Efficacy of articaine: a new amide local anaesthetic. J Am Dent Assoc 2000; 131:635-42.



  1. Malamed SF. Handbook of local anaesthesia. 4th ed. St Louis; CV mosby; 1997



  1. Rebolledo AS, Molina ED, Aytes LB, Escoda CG. Comparative study of anaesthetic efficacy of 4% articaine versus 2% lidocaine in inferior alveolar nerve block during surgical extraction of impacted mandibular third molars. Med Oral Patol Oral Cir Bucal 2007;12:E139-44.



  1. Fan S, Chen W L, Yang Z H, Huan Z Q. Comparison of the efficiencies of permanent maxillary tooth removal performed with single buccal infiltration versus routine buccal and palatal injection. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;107:359-363.



  1. Ukan S, Dayangac E, Araz K. Is permanent maxillary tooth removal without palatal injection possible?. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2006;102:733-5



  1. Oertel R, Oertel A, Weile K, Gramatte t, Feller K. The concentration of local anaesthetic in dental alveolus, comparative studies of lidocaine and articaine in mandible and maxilla. Schweiz Monatscchr Zahnmed 1994; 10:952-5.



  1. Malamed SF, Gagnon S, Leblanc D. A comparison between articaine HCl and

Lidocaine HCl in paediatric dental patients. Paediatr Dent 2000;22:307-11.

  1. Mikesell p, Nusstein J, Reader A, Beck M, Weaver J. A Comparison of Articaine and Lidocaine for Inferior Alveolar Nerve Blocks. J Endod 2005;31(4):265-70.





INFORMED CONSENT FORM

I _________________________ (name of the patient) hereby authorize the doctor in charge to administer any treatment such as anesthetics and to perform such operation as may be deemed necessary or advisable in diagnosis and treatment. I have been explained about my oral condition and the treatment planned.

I hereby give full consent to undergo surgery under local anesthesia. The doctor has explained to me about the advantages, disadvantages and the risk associated with the procedure in an understandable language.

CASE HISTORY PROFORMA

STUDY GROUP:

NAME: AGE: SEX:

OCCUPATION: O.P.NO.:

ADDRESS:

CHIEF COMPLAINT:

HISTORY OF PRESENTING ILLNESS:

PAST DENTAL HISTORY:

PAST MEDICAL HISTORY:

DRUG ALLERGY:

PERSONAL HISTORY:

GENERAL PHYSICAL EXAMINATION:

EXTRA-ORAL EXAMINATION:

FACIAL SYMMETRY:

FACIAL MEASUREMENTS: TRAGUS- CORNER OF MOUTH:

TRAGUS-SOFT TISSUE POGONION:



TMJ:

MOUTH OPENING:

INTRA-ORAL EXAMINATION:

SOFT TISSUE SURROUNDING THE IMPACTED TOOTH:

NORMAL/ INFLAMED

ULCER: PRESENT/ ABSENT

FIBROSED: YES/ NO

PERICORONITIS:

ACUTE INFECTION, IF ANY

SWELLING:

DISCHARGE:

PAIN/ DIFFICULTY IN CHEWING:

MAXILLARY THIRD MOLARS:

PRESENT/ ABSENT

IMPINGING ON SOFT TISSUE: YES/ NO

POSITION: NORMAL/ BUCCAL/ SUPRA-ERUPTED:

CONDITION OF MANDIBULAR SECOND MOLAR:

ORAL HYGIENE:

INVESTIGATIONS:

IOPAR:

OPG:

ROUTINE BLOOD AND URINE INVESTIGATION:

RADIOGRAPH AND CLINICAL CORRELATION:

DIAGNOSIS:

CLASSIFICATION:

WAR LINES: White:

Amber:

Red:

WHARFE ASSESSMENT: W (winter’s classification):

H (height of mandible):

A (angulation of the second molar):

R (shape and development of root):

F (size of follicular sac):

E (path of exit of the tooth):

TREATMENT PLANNING:


PATIENT RECORD


PATIENT NAME:



AGE:

TYPE OF PROCEDURE AND THE TOOTH INVOLVED:




TOTAL AMOUNT OF ANAESTHETIC SOLUTION USED (IN ML)




LATENCY( TIME TAKE FOR ONSET OF ANAESTHETIC ACTION IN MINUTES)




QUALITY OF ANAESTHESIA




DURATION OF THE SURGERY (IN MINUTES).





DURATION OF POST OPERATIVE ANAESTHESIA (IN MINUTES)




VAS SCORE





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