RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1 NAME AND ADDRESS OF THE DR.SONAM AGARWAL
CANDIDATE (in Block letters) POSTGRADUATE STUDENT,
DEPARTMENT OF PERIODONTICS,
V.S.DENTALCOLLEGE AND HOSPITAL,
K. R. ROAD, V. V. PURAM,
BANGALORE – 560 004.

2 NAME OF THE INSTITUITION V.S.DENTALCOLLEGE AND HOSPITAL, BANGALORE

3 COURSE OF STUDY AND SUBJECT MASTER OF DENTAL SURGERY,

PERIODONTICS.

4 DATE OF ADMISSION TO THE 31/05/2012

COURSE

5 A COMPARATIVE CLINICAL AND MICROBIOLOGICAL

TITLE OF THE TOPIC ASSESSMENT OF LOCALLY DELIVERED CURCUMIN AS AN
ADJUNCT TO SCALING & ROOT PLANING.
6. BRIEF RESUME OF THE INTENDED WORK –

6.1 Need for the study–Periodontitis is a multifactorial disease affecting the periodontium with

plaque being the primary etiologic factor. The goal of periodontal therapy is to prevent, arrest, control

or eliminate periodontitis and to restore the lost form, function, esthetics and comfort.1

Many treatment modalities are available to achieve the goal of periodontal therapy. This includes non

surgical periodontal therapy, such as scaling and root planing (SRP) alone or SRP plus systemic or

local antimicrobial/anti inflammatory agents , and surgical periodontal therapy.2

Different allopathic drugs have been used as local drug delivery agents. Some of the agents used till

date are tetracyclines doxycycline and minocycline; metronidazole; and chlorhexidine, but they are

relatively expensive.1

Various herbs having therapeutic qualities have been described in ancient literature one of which is

turmeric. Turmeric otherwise known as Circuma longa is a member of ginger family zingaberaceae. 3

Active ingredient of turmeric known as curcumin has antimicrobial, antioxidant, anti-inflammatory

and astringent properties which can be availed in treatment of various diseases.3,4

Since periodontal disease is a progressive inflammatory disease, use of curcumin extract as local drug

delivery can help in halting the disease process and as an effective adjunct to SRP with minimal

systemic toxicity, cost-effectiveness and better patient compliance. Thus there is a need to explore the

effect of local drug delivery system containing curcumin extract as an adjunct to SRP.

Aim of the study: To assess the effect of local drug delivery system containing curcumin extract as

an adjunct to scaling and root planing.

6.2 Review of literature:

 Turmeric contains more than two-dozen anti-inflammatory compounds including six different

COX-2 inhibitors, and its anti-inflammatory activities are well documented. By itself

curcumin in turmeric is a multifaceted anti-inflammatory agent, pleiotropically inhibiting not

only COX-2 but elastase, hyaluronidase, interleukin-12, leukotrienes, lipoxygenase,nitric

oxide, phospholipase, prostaglandins and tumor necrosis factor alpha.5

  Turmeric has been used for thousand years as a dye, flavouring agent and a medicinal herb.

Since turmeric has antimicrobial, anti-oxidant, astringent and other useful properties, it is quite

useful in Dentistry also.3

 In a split mouth study conducted using 2% turmeric gel as local drug delivery in periodontal

disease and BANA microbiological assay for red complex microorganisms, results showed

that the above said preparation can be effectively used in reducing disease parameters as an

adjunct to SRP than SRP alone with a significant reduction in trypsin like activity of red

complex i.e. BANA values.1

 In a recent study bioavailability of bucally delivered curcumin tablets by using different

concentration of bioenhancer and bioadhesive polymer was assessed and concluded that the

batch prepared with 5% polymer concentration,0.1% enhancer with 30 % backing layer was

the ideal batch.6

 Potential anti-inflammatory effects of systemically administered curcumin were assessed by

experimentally inducing periodontal disease in rats. Bone resorption was assessed by

microcomputer tomography and inflammatory status by stereometric analysis. Result showed

marked reduction of inflammation in curcumin treated animals. Hence it was concluded that

curcumin did not prevent alveolar bone resorption, but its potent anti-inflammatory effect

suggests it may have a therapeutic potential in periodontal diseases.7

6.3 Objectives of the study

The objectives of the present study are

1) To assess the efficacy of 1% curcumin extract as local drug delivery on the clinical &

microbiological parameters of periodontal disease as an adjunct to SRP.

2) To compare the efficacy of adjunctive use of SRP and 1% curcumin extract with SRP alone.
3) To assess the release pattern of the local drug delivery system containing 1% curcumin extract.

7. MATERIALS AND METHODS

7.1 SOURCE OF THE DATA

 Study design: Comparative study.

 Source and setting/venue: The study will be conducted on both male & female subjects

meeting the inclusion and exclusion criteria, reporting to the Department of Periodontics,

V.S.Dental College & Hospital. Curcumin extract will be procured from Natural Remedies

Private Limited Bangalore and incorporated in a biodegradable chip measuring 5mm x 4mm x

0.3 mm by  Visveswarapura Institute of Pharmaceutical Sciences. It will be made clear to all

the subjects that the participation is voluntary. Verbal and written informed consent will be

obtained from those who agree to participate. A total of 30 sites will be selected. The sites will

be divided into 2 groups:-

 Control Group-consisting of 15 sites in subjects with chronic periodontitis who

will receive SRP alone.

 Test Group-consisting of 15 sites in subjects with chronic periodontitis who will

receive SRP along with 1% curcumin extract as local drug delivery in the form

of biodegradable chip.

7.2 METHOD OF COLLECTION OF DATA

7.2.1 Sampling technique used: Two stage sampling

Stage 1: Purposive sampling.

Stage 2:Simple Random sampling

7.2.2 Sample size: Subjects will be grouped into 2 groups ,each group consisting of 15

sites.

7.2.3 Sample selection

  Inclusion criteria

1. Patient who are in the age range of 20-55 years of either gender i.e. male or female.

2. Patients who are systemically healthy.

3. Patient diagnosed with localized or generalized chronic periodontitis.

4. Patients with clinical attachment loss ≥ 3mm.

5. Patients with pocket depth ≥ 5mm.

 Exclusion criteria

1. Patients with immunologic disorders, hepatitis, HIV infection.

2. Pregnant or lactating mothers.

3. Patients taking oral contraceptives.

4. Patients who have received antibiotic therapy within previous 3 months.

5. Patients who have undergone periodontal treatment in last 6 months.

6. Patients who are smokers.

COLLECTION OF DATA

A clinical proforma will be used to collect the data from the subjects. The Probing Depth (PD),

Clinical Attachment Level (CAL) will be recorded using Williams periodontal probe. Plaque index

(PI-Silness and Loe), Gingival index (Loe and Silness) & Gingival Bleeding index (Ainamo and Bay)

will also be recorded. Microbiological samples will be collected from 10 sites in each group from the

periodontal pocket using a sterile curette at baseline, 1 month, 3 months and 6 months. Collected

samples will be assessed for red complex organism using polymerase chain reaction.
 7.2.4 Duration of study–

1.5 years

7.2.5 Stastical analysis of data:

 Student’s t test

7.3 7.3 Does the study require any investigation or interventions to be conducted on

Patients?

-Yes-

1) Collection of microbiological samples.

2) Scaling and root planing.

3) Placement of local drug delivery containing 1% curcumin extract in the form of biodegradable

chip.

7.4 Has ethical clearance been obtained from your institution?

Obtained.
 8. LIST OF REFERENCES
Behel R, Mali AM, Glida SS, Paradkar AR. Evaluation of local-drug delivery system containing 2%
1
whole turmeric gel used as an adjunct to scaling and root planning in chronic periodontitis: A clinical

and microbiological study.J Indian Soc Periodontol 2011;15(1):35-38.

Pradeep AR, Thorat MS.Clinical Effect of Subgingivally Delivered Simvastatin in the Treatment of

2 Patients With Chronic Periodontitis: A Randomized Clinical Trial. J Periodontol 2010;81(2):214-222.

Chaturvedi TP.Uses of turmeric in dentistry: An update. Indian J Dent Res 2009;20(1): 107-109.
3

Chattopadhyay I, Biswas K, Bandyopadhyay U, Banerjee RK.Turmeric and curcumin: Biological

4
actions and medicinal applications.Curr Sci 2004;87(1):44-53.

Duke JA.Turmeric, the Queen of COX-2-Inhibitors.Alternative & Complementary Therapies

5
2007;13(5): 229-234.

Latheeshjlal L, Mural AS, Malik A, Vaidya MJ. Formulation and Development of Buccal Drug

Delivery System containing Curcumin.Int. J. PharmTech Res 2011; 3(1):37-41.

6

Guimaraes MR, Coimbra LS, de Aquino SG, Spolidorio LC, Kirkwood KL, Rossa C Jr . Potent anti-
7
inflammatory effects of systemically-administered curcumin modulates periodontal disease in vivo. J

Periodontal Res 2011; 46(2):269-279.

 V.S DENTAL COLLEGE AND HOSPITAL, BANGALORE.
CONSENT FORM
I ……………………………………. son/daughter/wife of ……………………………………… aged…………….. resident

of …………………………………………………………………. do hereby give consent to perform scaling and root planing

,placement of local drug delivery containing curcumin and obtain sub-gingival microbial samples for research purpose. The

procedure has been explained to me in my own language. I agree that no responsibility will be attached to the surgeon or the

hospital authorities.

Signature of Patient/Parent:

Signature of Witness:
Place: Signature of Researcher:
Date:
 CRITERIA FOR INDICES
PLAQUE INDEX (SILNESS P & LOE H, 1964)

Method: The evaluation or scoring is done on the entire dentition or on selected teeth. Only plaque of cervical third of the
tooth is evaluated. The surfaces examined are the four gingival areas of the tooth i.e., the distofacial, facial, mesiofacial &
lingual surfaces. The mouth mirror, a light source, a dental explorer and air drying of the teeth and gingiva are used in the
scoring of this index.
SCORING CRITERIA:

Score Criteria

0 No plaque

1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth.
The plaque may be seen in situ only after application of disclosing solution or by
using the probe on the tooth surface.

2 Moderate accumulation of soft deposits within the gingival pocket, or the tooth and
the gingival margin which can be seen with the naked eye.

3 Abundance of soft matter within the gingival pocket and / or on the tooth and gingival
margin.
∑ of scores of all surfaces
Plaque score =
No . of Surfaces examined
Suggested nominal scale for patient evaluation:

Rating Scores

Excellent 0

Good 0.1 – 0.9

Fair 1.0 – 1.9

Poor 2.0 – 3.0

GINGIVAL INDEX (GI) (LOE H AND SILNESS P, 1963)

Method: The severity of gingivitis is scored on all teeth. To obtain GI, the tissues surrounding each tooth are divided into
four gingival scoring units: distal-facial papilla, facial margin, mesial-facial papilla & entire lingual gingival margin. A blunt
instrument such as periodontal probe is used to assess the bleeding potential of the tissues.
SCORING CRITERIA:

Score Criteria

0 Absence of inflammation / normal gingiva

1 Mild inflammation, slight change in colour, slight edema; no bleeding on probing

2 Moderate inflammation; moderate glazing, redness, edema & hypertrophy. Bleeding

on probing

3 Severe inflammation; marked redness & hypertrophy ulceration. Tendency to

spontaneous bleeding.

Calculation:
Gingival index score for the area = sum of scores around each tooth
∑ of scores around each tooth
Gingival index score for the tooth =
4
∑ of scores around each tooth
Gingival index score per person =
No . of teeth examined
The numerical scores of gingival index may be associated with varying degrees of clinical gingivitis as follows:

GINGIVAL SCORES CONDITION

0.1-1.0 Mild Gingivitis

1.1-2.0 Moderate Gingivitis

2.1-3.0 Severe Gingivitis

GINGIVAL BLEEDING INDEX (AINAMO AND BAY1975)

Method: The severity of gingivitis is scored on all teeth. To obtain GI, the tissues surrounding each tooth are divided into
four gingival scoring units: distal-facial papilla, facial margin, mesial-facial papilla & entire lingual gingival margin. A blunt
instrument such as periodontal probe is used to assess the bleeding potential of the tissues.

SCORING CRITERIA:

SCORE CRITERIA

+ Appearance of bleeding within 10 seconds of probing gingival crevice gently with a periodontal probe

- Absence of bleeding.

Number of positive scores:

Number of negative scores:
Gingival Bleeding index Score =( sum of positive scores/Number of margins scored)x100
 CASE RECORD PROFORMA
Name of the patient: O.P. No. :
Age/Sex:
Address & Ph. No.:
Occupation:
Chief complaint:
History of Present Illness:
Medical history:
Past Dental History:
Family History:
Habits:
Clinical Examination:
Oral examination:

PLAQUE INDEX (SILNESS P & LOE H, 1964):

Scoring:
18 17 16 15 14 13 12 11 21 22 23 24 25 26 27 28

48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38

Plaque score =
∑ of scores of all surfaces
No . of Surfaces examined

Rating:
GINGIVAL INDEX (LOE H AND SILNESS P, 1963):

Scoring:

18 17 16 15 14 13 12 11 21 22 23 24 25 26 27 28

48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38

Gingival Index score =

∑ of scores of all surfaces
No .of margins examined

Rating:

GINGIVAL BLEEDING INDEX(AINAMO AND BAY1975)

Scoring:

18 17 16 15 14 13 12 11 21 22 23 24 25 26 27 28

48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38

Number of positive scores:

Number of negative scores:
Gingival Bleeding index Score

PERIODONTAL POCKET DEPTH:

18 17 16 15 14 13 12 11 21 22 23 24 25 26 27 28
 48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38

CLINICAL ATTACHMENT LEVEL:

18 17 16 15 14 13 12 11 21 22 23 24 25 26 27 28

48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38

DIAGNOSIS: