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 2ND STAGE
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

5 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

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 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, magnitude
of 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 , its 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 leakage of
intracellular components of the organisms. The gel when placed over the surgical wound has
a more direct effect and prolongs the active effect of the drug.3
The 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 oral
cavity to shield exposed or sensitized nerve endings from
overstimulation.Polyvinylpyrrolidone - It is a hydrophilic polymer with
muco-adherent and film-forming properties, which enhances tissue
hydration.Hyaluronic acid (as sodium hyaluronate) - It coats the oral
mucosa, enhances tissue hydration, and accelerates
healing.Glycyrrhetinic acid - It is a breakdown product of glycyrrhizin, the
active component of licorice and has anti-inflammatory properties that aid
in ulcer healing. It is also used as a flavoring agent.1
Placebo 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.
Thus the study is undertaken 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.

6.2 REVIEW OF LITERATURE:

A study was conducted to study the symptoms of patients during the 7 days after
incisional biopsy of the oral mucosa and the application of polyvinylpyrrolidone
sodium hyalunurate gel or 0.2 % chlorhexidine digluconate gel. They obsereved in 90
patients that most intense peaks 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 week of the study period.
The maximum level of pain was significantly lower in other two groups than in control
group. Therefore they concluded that topical application of polyvinylpyrrolidone
sodium hyalonurate and chlorhexidine digluconate decreases the symptoms of oral
mucosa biopsy.1
A study was conducted on the efficacy of a topical HA preparation (0.2%) in the
management of recurrent aphthous in 120 patients in a randomized, placebo-controlled,
double-blind trial. Patients treated with topical HA recorded few ulcers on day 5 of the
investigation than those treated with placebo. Also, the occurrence of new ulcers was
lower in the HA-treated group on day 4 when compared with placebo-treated group.
This article reviewed the mechanism of action, indications and efficacy of topical
Hyaluronic 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 70%
decrease in post operative alveolar osteitis in the gel group due to greater bioavailability
of the drug. Thus the study concluded that the topical application of bioadhesive
chlorhexidine gel to surgical wound during the post operative week may decrease the
incidence of alveolar oseitis after extraction of third molars. 3
A study conducted on the incidence and severity of pain and swelling during the 7 days
after biopsy of the oral mucosa. A visual analogue scale was used to assess the post op
pain and swelling in 84 patients with lesions that were amenable to histopathological
study. The found that maximum pain intensity was recorded after 2 hours, while
swelling peaked between 6-48 hours after biopsy. Pain was greater in women than
men.4
A study was conducted on the use of visual analog scale in the immediate postoperative
period , an intra subject variability and its correlation with the numeric scale. It was
found visual analog scale correlates well with a verbal ll-point scale
but any individual determination has an imprecision of + or - 20 mm.5

6.3 OBJECTIVES OF THE STUDY:

To assess the effectiveness of polyvinlypyrrolidone sodium hyalonurate gel on surgical
wounds in post-operative patients having incisional biopsy of oral mucosa.
To assess the effectiveness of 0.2 % chlorhexidine digluconate gel on surgical wounds in
post-operative patients having incisional biopsy of oral mucosa.
To assess the effectiveness of placebo gel on surgical wounds in post-operative patients
having incisional biopsy of oral mucosa.
To 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 post-operative pain.

7. MATERIALS AND METHODS:

7.1 Sources of data:
60 patients with lesions in oral mucosa requiring histopathologic study for diagnostic
purpose will be selected from the Department of Oral Medicine and Radiology, V.S.D.C.H,
Bangalore, Karnataka.

7.2 Inclusion Criteria

Patients with lesion in oral mucosa requiring incisional biopsy and histopathological
studies.

7.3 Exclusion criteria:

Patients with an allergy or hypersensitivity to the products used.
Patients with any systemic disease such as uncontrolled diabetes, uncontrolled
hypertension, etc.
Immunocompromised patients such as AIDS, etc.

7.4 PLACE OF STUDY:

Department of Oral Medicine and Radiology, V.S.D.C and Hospital, K. R. Road, V. V. Puram,
Bangalore, Karnataka

7.5 STUDY DESIGN:

Comparative study

7.6 SAMPLE DESIGN:

Purposive sampling

7.7 STUDY DURATION:

One and half years

7.8 SAMPLE SIZE:

60 ( 20 control placebo group, 20- PVP-SH gel group, 20- 2% chlorhexidine
digluconate gel group )

7.9 Proposed Statistical Analysis

Kruskal-Wallis test
Pearsons X2 test

7.10 Methods of collection of data and methodology:

Patients who will undergo incisional biopsies of oral mucosa under local anaesthesia will be
selected and randomly allocated a number into 1 of 3 groups.
An informed consent of the patient will be taken.
After biopsy, group I (control group) will receive a topical placebo gel application. Group II,
the site of surgical intervention will be treated topically with polyvinylpyrrolidone sodium
hyalonurate gel 3 times daily for 7 days. The first application will be given immediately at
post-operative period. Group III, will be treated same as group II but with 0.2% chlorhexidine
digluconate gel.
Patients who smoke will be advised to stop smoking for a week during the
study.
To evaluate the intensity of pain, a visual analog scale (VAS) will be used. This VAS consist
of a 100 mm horizontal line anchored at one end with the words no pain and at the other
end with the words worst pain imaginable. Each patient will be instructed on how to use
the scale and asked to mark the intensity of pain at 2, 4, 6, 12 and 24 hours after biopsy, and
daily for the next 6 days. The measurements will be recorded by the patient at home at 12:00
pm. The patients will be examined at 24 hours and 7 days after the biopsy. Records will be
kept of patient's age, gender and biopsy site. The results obtained from these data will be later
analysed statistically.

7.11 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR

INTERVENTION TO BE CONDUCTED ON PATIENTS OR HUMANS
OR ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY
Yes
This study requires a topical application of drugs on the oral mucosal surgical scar site.

7.12 HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM

YOUR INSTITUTION?
YES.

8. LIST OF REFERENCES:

1.Pia Lpez-Jornet, Fabio Camacho-Alonso, Ascensin Martinez-Canovas

Clinical evaluation of Polyvinylpyrrolidone Sodium Hyalonurate Gel and
0.2% Chlorhexidine Gel for Pain After Oral Mucosa Biopsy: A Preliminary
Study
Journal of Oral and Maxillofacial Surgery, 68(9), 2010, 2159-2163
2.Pranav Kapoor, Shabina Sachdeva, and Silonie Sachdeva

Topical hyaluronic acid in the management of oral ulcers.

Indian J Dermatol. 56(3) : 2011 : 300302.
3.Effectiveness of Chlorhexidine gel versus Chlorhexidine rinse
reducing alveolar osteitis in mandibular third molar surgery.
J Oral Maxillofacial Surg 66: 2008 : 441-445

in

4.Fabio Camacho-Alonso , Pia Lopez-Jornet

Study of pain and swelling after oral mucosal biopsy
British Journal of Oral and Maxillofacial Surgery, 46(2008), 301-303
5. Lauren J. DeLoach, Michael S. Higgins, Amy B. Caplan and Judith L. Stiff
The visual analog scale in the immediate postoperative period:
intrasubject variability and correlation with a numeric scale.
Anesthesia Analg , 86(1998),102-106
1.

Signature of candidate

`
Remarks of the guide

11

Name and designation of

11.1 Guide

Dr. Deepak T.A MDS

Professor ,
Department of Oral Medicine and Radiology

11.2 Signature

11.3 Co-guide

Dr. M. Manjunath MDS

Prof. and HOD,
Department of Oral Medicine and Radiology

11.4 Signature

11.5 Head of the department

11.6 Signature

12

12.1 Remarks of the chairman and

principal

12.2 Signature

Dr. M. Manjunath MDS

Prof. and HOD,
Department of Oral Medicine and Radiology

Name :____________
Sex:____
Day 1
Date:

2 hours after the procedure

Time :
.

4 hours after the procedure

Time:
.

6 hours after the procedure

Time:
.

12hours after the procedure

Time:
.

Age:______

Day 2
Date:

Day 3
Date:

Day 4
Date:

Day 5
Date:

Day 6
Date

Day 7
Date:

DEPARTMENT OF ORAL MEDICINE AND

RADIOLOGY
CONSENT FORM
I_____________________ son/daughter of __________________ aged ________ resident of
________________________________ being under the treatment of Dr. Aastha Mehta do hereby
give consent to the performance of drugs/ medical/ surgical/ anaesthesia/ diagnostic procedure upon
myself. The procedure has been explained to me in my own language and also the likely 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.

Place:
Date:

Signature of the physician

Witness

Signature of the patient/guardian

Signature of