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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA,

BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1 NAME OF THE

CANDIDATE AND

ADDRESS

DR. AASTHA MEHTA

ROOM NO. 422

KIMS LADIES HOSTEL

BANASHANKARI 2NDSTAGE

BANGLORE

2 NAME OF THE

INSTITUTION

VOKKALIGARA SANGHA DENTAL

COLLEGE AND HOSPITAL

3 COURSE OF STUDY AND

SUBJECT

MASTER OF DENTAL SURGERY IN

ORAL MEDICINE AND RADIOLOGY

4 DATE OF ADMISSION JUNE 2011

TITLE OF THE TOPIC

A COMPARATIVE ASSESSMENT OF

POLYVINYLPYRROLIDONE SODIUM

HYALURONATE GEL, 0.2!

CHLORHEXIDINE GEL AND

PLACEBO GEL FOR PAIN AFTER

ORAL MUCOSAL BIOPSY " A

CLINICAL STUDY

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#. BRIEF RESUME OF THE INTENDED $ORK%

#.1 NEED FOR THE STUDY%

Biopsy of lesions of the oral mucous membranes is a common minor surgical procedure,

usually performed under local anaesthesia. It is considered as an irrefutable test for diagnosis

of illness of the oral mucosa and subsequent planning of suitable therapeutic treatment.

Although pain, swelling and trismus following surgical removal of teeth has been

investigated thoroughly in the past, there are not many reports in the literature on the pain

experience in patients with healing wounds following oral mucosal biopsy.

All surgical procedures produce secondary effects such as pain and inflammation, magnitudeof which depends on the degree of tissue damage produced. Immediately after oral biopsy,

patients might find it difficult to perform oral hygiene practices because the tissue of their

mouth is extremely fragile.

In such cases a bioadhesive gel containing 0.2 chlorhexidine is a biguanide antiseptic

agent , it!s antimicrobial effects are associated with the attractions between chlorhexidine

"cation# and negatively charged bacterial cells, after chlorhexidine is absorbed onto the

organism$s cell wall, it disrupts the integrity of the cell membrane and causes the lea%age of

intracellular components of the organisms. &he gel when placed over the surgical wound has

a more direct effect and prolongs the active effect of the drug. '

&he application of Aloclair, a bioadherent concentrated viscous oral gel composed of

polyvinlypyrrolidone, hyaluronic acid and glycyrrhetinic acid, has been recommended to treat

the symptoms of oral lesions of different etiologies.

Topical HA 0.2% or Aloclair gel forms a protective coating around the oralcavity to shield exposed or sensitized nerve endings fromoverstimulation.Polyvinylpyrrolidone - t is a hydrophilic polymer !ithmuco-adherent and "lm-forming properties# !hich enhances tissuehydration.Hyaluronic acid $as sodium hyaluronate - t coats the oralmucosa# enhances tissue hydration# and accelerates

healing.&lycyrrhetinic acid - t is a 'rea(do!n product of glycyrrhizin# theactive component of licorice and has anti-in)ammatory properties that aidin ulcer healing. t is also used as a )avoring agent.*

(lacebo gel will consist of polyethylene glycol which is a polyether compound and is

commonly used as an excipient "pharmacologically inactive substance used as a carrier for

the active ingredients of a medication# , colour and taste of which will be matched to the

other two gels used.

&hus the study is underta%en to evaluate the efficacy of the polyvinylpyrrolidone sodium

hyaluronate gel"Aloclair# ,0.2 chlorhexidine digluconate and placebo gel applied topically

to the surgical wound after incisional oral mucosa biopsy.

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#.2 REVIE$ OF LITERATURE%

A study was conducted to study the symptoms of patients during the ) days after

incisional biopsy of the oral mucosa and the application of polyvinylpyrrolidone

sodium hyalunurate gel or 0.2 chlorhexidine digluconate gel. &hey obsereved in *0

patients that most intense pea%s of maximal pain were recorded in the control group

where no topical drug was given, with the maximal pain occurring 2 hours after

surgery, after which it tends to diminish gradually during the wee% of the study period.

&he maximum level of pain was significantly lower in other two groups than in control

group. &herefore they concluded that topical application of polyvinylpyrrolidone

sodium hyalonurate and chlorhexidine digluconate decreases the symptoms of oral

mucosa biopsy.+

A study was conducted on the efficacy of a topical A preparation "0.2# in the

management of recurrent aphthous in +20 patients in a randomi-ed, placebocontrolled,

doubleblind trial. (atients treated with topical A recorded few ulcers on day / of the

investigation than those treated with placebo. Also, the occurrence of new ulcers was

lower in the Atreated group on day when compared with placebotreated group.

&his article reviewed the mechanism of action, indications and efficacy of topical

yaluronic acid gel in the management of oral ulcers.2

A study was conducted to evaluate the effectiveness of chlorhexidine gel versus

chlorhexidine rinse in reducing post operative alveolar osteitis and there was a )0decrease in post operative alveolar osteitis in the gel group due to greater bioavailability

of the drug. &hus the study concluded that the topical application of bioadhesive

chlorhexidine gel to surgical wound during the post operative wee% may decrease the

incidence of alveolar oseitis after extraction of third molars. '

A study conducted on the incidence and severity of pain and swelling during the ) days

after biopsy of the oral mucosa. A visual analogue scale was used to assess the post op

pain and swelling in 1 patients with lesions that were amenable to histopathological

study. &he found that maximum pain intensity was recorded after 2 hours, while

swelling pea%ed between 1 hours after biopsy. (ain was greater in women thanmen.

A study was conducted on the use of visual analog scale in the immediate postoperative

period , an intra sub3ect variability and its correlation with the numeric scale. It was

foundvisual analog scale correlates !ell !ith a ver'al ll-point scale

'ut any individual determination has an imprecision of + or - 20 mm.,

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#.3 OBJECTIVES OF THE STUDY%

&o assess the effectiveness of polyvinlypyrrolidone sodium hyalonurate gel on surgical

wounds in postoperative patients having incisional biopsy of oral mucosa.

&o assess the effectiveness of 0.2 chlorhexidine digluconate gel on surgical wounds in

postoperative patients having incisional biopsy of oral mucosa.

&o assess the effectiveness of placebo gel on surgical wounds in postoperative patients

having incisional biopsy of oral mucosa.

&o compare the effectiveness polyvinlypyrrolidone sodium hyalonurate gel, 0.2

chlorhexidine digluconate gel and placebo gel on surgical wounds of incisional biopsy of

oral mucosa in controlling postoperative pain.

&. MATERIALS AND METHODS%

&.1 S'()*+ '- //%

0 patients with lesions in oral mucosa requiring histopathologic study for diagnostic

purpose will be selected from the 4epartment of 5ral 6edicine and 7adiology, 8.9.4.:.,

Bangalore, ;arnata%a.

&.2 I*(' C)+)/

(atients with lesion in oral mucosa requiring incisional biopsy and histopathological

studies.

&.3 E*(' *)+)/%

(atients with an allergy or hypersensitivity to the products used.

(atients with any systemic disease such as uncontrolled diabetes, uncontrolled

hypertension, etc.

Immunocompromised patients such as AI49, etc.

&.4 PLACE OF STUDY%

4epartment of 5ral 6edicine and 7adiology, 8.9.4.: and ospital, ;. 7. 7oad, 8. 8. (uram,

Bangalore, ;arnata%a

&. STUDY DESIGN%

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:omparative study

&.# SAMPLE DESIGN%

(urposive sampling

&.& STUDY DURATION%

5ne and half years

&.5 SAMPLE SI6E%

0 $ 20 control place'o group# 20- PP-/H gel group# 20- 2% chlorhexidine

digluconate gel group

&.7 P)'8'+ S/*/ A/9

;rus%alroup III, will be treated same as group II but with 0.2 chlorhexidine

digluconate gel.

Patients !ho smo(e !ill 'e advised to stop smo(ing for a !ee( during the

study.

&o evaluate the intensity of pain, a visual analog scale "8A9# will be used. &his 8A9 consistof a +00 mm hori-ontal line anchored at one end with the words ?no pain@ and at the other

end with the words ?worst pain imaginable@. ach patient will be instructed on how to use

the scale and as%ed to mar% the intensity of pain at 2, , , +2 and 2 hours after biopsy, and

daily for the next days. &he measurements will be recorded by the patient at home at +200

pm. &he patients will be examined at 2 hours and ) days after the biopsy. 7ecords will be

%ept of patient$s age, gender and biopsy site. &he results obtained from these data will be later

analysed statistically.

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* 9ignature of candidate

D

7emar%s of the guide

++ Eame and designation of

++.+ >uide

++.2 9ignature

++.' :oguide

++. 9ignature

++./ ead of the department

++. 9ignature

4r. 4eepa% &.A 649

(rofessor ,

4epartment of 5ral 6edicine and 7adiology

4r. 6. 6an3unath 649

(rof. and 54,

4epartment of 5ral 6edicine and 7adiology

4r. 6. 6an3unath 649

(rof. and 54,

4epartment of 5ral 6edicine and 7adiology

+2 +2.+ 7emar%s of the chairman andprincipal

+2.2 9ignature

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Name :____________ Age:______

Sex:____

Day 1Date: .

2 hours after the procedure

Time 8 .

hours after the procedure

Time8 .

9 hours after the procedure

Time8 .

*2hours after the procedure

Time8 .

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Day 2

Date: .

Day 3

Date: .

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Day 4

Date: .

Day 5

Date: .

Day 6Date .

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Day 7

Date: .

DEPARTMENT OF ORAL MEDICINE AND

RADIOLOGY

CONSENT FORM

IFFFFFFFFFFFFFFFFFFFFF sonGdaughter of FFFFFFFFFFFFFFFFFF aged FFFFFFFF resident of

FFFFFFFFFFFFFFFFFFFFFFFFFFFFFFFF being under the treatment of 4r. Aastha 6ehta do hereby

give consent to the performance of drugsG medicalG surgicalG anaesthesiaG diagnostic procedure upon

myself. &he procedure has been explained to me in my own language and also the li%ely adverse

effects of the drugs being used has been explained and I agree that no responsibility will be attached

to the surgeon or the hospital staff.

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(lace

4ate 9ignature of the patientGguardian

/ignature of the physician /ignature of

Citness

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