You are on page 1of 13

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

2 % chlorhexidine is a biguanide antiseptic agent .1 NEED FOR THE STUDY: Biopsy of lesions of the oral mucous membranes is a common minor surgical procedure. BRIEF RESUME OF THE INTENDED WORK: 6.2% or Aloclair gel forms a protective coating around the oral cavity to shield exposed or sensitized nerve endings from overstimulation. colour and taste of which will be matched to the other two gels used. which enhances tissue hydration.6. the active component of licorice and has anti-inflammatory properties that aid in ulcer healing.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) .2 % chlorhexidine digluconate and placebo gel applied topically to the surgical wound after incisional oral mucosa biopsy. The gel when placed over the surgical wound has a more direct effect and prolongs the active effect of the drug.Hyaluronic acid (as sodium hyaluronate) . magnitude of which depends on the degree of tissue damage produced. . It is considered as an irrefutable test for diagnosis of illness of the oral mucosa and subsequent planning of suitable therapeutic treatment. In such cases a bioadhesive gel containing 0.Polyvinylpyrrolidone . a bioadherent concentrated viscous oral gel composed of polyvinlypyrrolidone. after chlorhexidine is absorbed onto the organism's cell wall. enhances tissue hydration. usually performed under local anaesthesia. Topical HA 0.0. Thus the study is undertaken to evaluate the efficacy of the polyvinylpyrrolidone sodium hyaluronate gel(Aloclair) .It is a hydrophilic polymer with muco-adherent and film-forming properties. Immediately after oral biopsy. has been recommended to treat the symptoms of oral lesions of different etiologies. and accelerates healing. it’s antimicrobial effects are associated with the attractions between chlorhexidine (cation) and negatively charged bacterial cells. hyaluronic acid and glycyrrhetinic acid. swelling and trismus following surgical removal of teeth has been investigated thoroughly in the past. it disrupts the integrity of the cell membrane and causes the leakage of intracellular components of the organisms. It is also used as a flavoring agent. Although pain.3 The application of Aloclair. patients might find it difficult to perform oral hygiene practices because the tissue of their mouth is extremely fragile. All surgical procedures produce secondary effects such as pain and inflammation.Glycyrrhetinic acid .It coats the oral mucosa. there are not many reports in the literature on the pain experience in patients with healing wounds following oral mucosal biopsy.It is a breakdown product of glycyrrhizin.

5 . Therefore they concluded that topical application of polyvinylpyrrolidone sodium hyalonurate and chlorhexidine digluconate decreases the symptoms of oral mucosa biopsy. placebo-controlled. after which it tends to diminish gradually during the week of the study period. This article reviewed the mechanism of action. 3 A study conducted on the incidence and severity of pain and swelling during the 7 days after biopsy of the oral mucosa. Patients treated with topical HA recorded few ulcers on day 5 of the investigation than those treated with placebo. with the maximal pain occurring 2 hours after surgery.2%) in the management of recurrent aphthous in 120 patients in a randomized. indications and efficacy of topical Hyaluronic acid gel in the management of oral ulcers. Pain was greater in women than men.2 % chlorhexidine digluconate gel. an intra subject variability and its correlation with the numeric scale.1 A study was conducted on the efficacy of a topical HA preparation (0. They obsereved in 90 patients that most intense peaks of maximal pain were recorded in the control group where no topical drug was given. 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. double-blind trial. The maximum level of pain was significantly lower in other two groups than in control group. the occurrence of new ulcers was lower in the HA-treated group on day 4 when compared with placebo-treated group. Also. while swelling peaked between 6-48 hours after biopsy.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.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 0.20 mm.4 A study was conducted on the use of visual analog scale in the immediate postoperative period . It was found visual analog scale correlates well with a verbal ll-point scale but any individual determination has an imprecision of + or .6. The found that maximum pain intensity was recorded after 2 hours.

V.S. 7.2 % chlorhexidine digluconate gel on surgical wounds in post-operative patients having incisional biopsy of oral mucosa. Patients with any systemic disease such as uncontrolled diabetes.6. 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. MATERIALS AND METHODS: 7. Karnataka 7. To assess the effectiveness of 0. Karnataka.3 Exclusion criteria: Patients with an allergy or hypersensitivity to the products used. etc. Road. Bangalore. K. 7.4 PLACE OF STUDY: Department of Oral Medicine and Radiology.D.S.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. R. To compare the effectiveness polyvinlypyrrolidone sodium hyalonurate gel. 7.C and Hospital. uncontrolled hypertension. Puram. Immunocompromised patients such as AIDS. To assess the effectiveness of placebo gel on surgical wounds in post-operative patients having incisional biopsy of oral mucosa.2 Inclusion Criteria Patients with lesion in oral mucosa requiring incisional biopsy and histopathological studies. 0.C.5 STUDY DESIGN: .D. V. Bangalore.2 % chlorhexidine digluconate gel and placebo gel on surgical wounds of incisional biopsy of oral mucosa in controlling post-operative pain.H. etc. V.

9 Proposed Statistical Analysis Kruskal-Wallis test Pearson’s X2 test 7.6 SAMPLE DESIGN: Purposive sampling 7.2% chlorhexidine digluconate gel. An informed consent of the patient will be taken. 20.10 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. Patients who smoke will be advised to stop smoking for a week during the study. will be treated same as group II but with 0. group I (control group) will receive a topical placebo gel application. and daily for the next 6 days.PVP-SH gel group. 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. the site of surgical intervention will be treated topically with polyvinylpyrrolidone sodium hyalonurate gel 3 times daily for 7 days. a visual analog scale (VAS) will be used.Comparative study 7.2% chlorhexidine digluconate gel group ) 7. 6. 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”. The results obtained from these data will be later analysed statistically. To evaluate the intensity of pain. . 4. 20.7 STUDY DURATION: One and half years 7. gender and biopsy site. Each patient will be instructed on how to use the scale and asked to mark the intensity of pain at 2. Group III. 12 and 24 hours after biopsy. Records will be kept of patient's age. Group II. The first application will be given immediately at post-operative period. After biopsy.8 SAMPLE SIZE: 60 ( 20 – control placebo group.

8. 56(3) : 2011 : 300–302. LIST OF REFERENCES: 1. Michael S. 68(9). 3.7. Pia Lopez-Jornet Study of pain and swelling after oral mucosal biopsy British Journal of Oral and Maxillofacial Surgery. and Silonie Sachdeva Topical hyaluronic acid in the management of oral ulcers. Higgins. Shabina Sachdeva. Ascensión Martinez-Canovas Clinical evaluation of Polyvinylpyrrolidone Sodium Hyalonurate Gel and 0. Fabio Camacho-Alonso.2% Chlorhexidine Gel for Pain After Oral Mucosa Biopsy: A Preliminary Study Journal of Oral and Maxillofacial Surgery. Caplan and Judith L. 2010.102-106 1. 7. Lauren J.12 HAS THE ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION? YES. Amy B. Stiff The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale.Effectiveness of Chlorhexidine gel versus Chlorhexidine rinse reducing alveolar osteitis in mandibular third molar surgery.Fabio Camacho-Alonso .Pranav Kapoor.Pia López-Jornet. 46(2008). DeLoach. Anesthesia Analg .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. J Oral Maxillofacial Surg 66: 2008 : 441-445 in 4. . Indian J Dermatol. 2159-2163 2. 86(1998). 301-303 5.

Deepak T. Manjunath MDS Prof. and HOD.6 Signature 12 12.4 Signature 11. and HOD. Department of Oral Medicine and Radiology 11.3 Co-guide Dr.2 Signature Dr.A MDS Professor . Manjunath MDS Prof.9 Signature of candidate ` Remarks of the guide 11 Name and designation of 11. M.1 Remarks of the chairman and principal 12.5 Head of the department 11.1 Guide Dr.2 Signature 11. Department of Oral Medicine and Radiology 11. Department of Oral Medicine and Radiology . M.

12hours after the procedure Time: . 4 hours after the procedure Time: .Name :____________ Sex:____ Day 1 Date: . Age:______ . 2 hours after the procedure Time : . 6 hours after the procedure Time: .

. Day 3 Date: .Day 2 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. 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. Aastha Mehta do hereby give consent to the performance of drugs/ medical/ surgical/ anaesthesia/ diagnostic procedure upon myself.

Place: Date: Signature of the physician Witness Signature of the patient/guardian Signature of .