Rajiv Gandhi University of Health Sciences s285

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / Name of the candidate and permanent address
(In block letters) / DR. ASHUTOSH R. TERVANKAR.
FLAT NO-204 , VINAYAK DARSHAN , GAVANPADA ROAD , GAVANPADA , MULUND (EAST) , MUMBAI , MAHARASHTRA - 400 081.
Temporary Address / ROOM NO : 27 , NILGIRI BLOCK , M.S.R. HOSTELS , GNANAGANGOTHRI CAMPUS, MSRIT POST , MSR NAGAR , BANGALORE – 560 054.
2. / Name of the institution / M.S.RAMAIAH DENTAL COLLEGE AND HOSPITAL,
BANGALORE- 54.
3. / Course of the study and subject / Master of Dental Surgery (M.D.S.)
Department of Periodontics
4. / Date of admission to course / 30/05/2012
5. / Title of the topic
EFFECTIVENESS OF SUBGINGIVALLY DELIVERED 0.4% MOXIFLOXACIN GEL AND 0.1% OFLOXACIN GEL IN THE TREATMENT OF CHRONIC PERIODONTITIS- A RANDOMIZED CONTROLLED CLINICAL TRIAL

6. BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

Periodontitis is a multifactorial disease in which bacteria plays an essential role, the control of its prevalence and progression requires a reduction of subgingival microbial plaque mass or at least a suppression of periodontopathic bacteria. Adjunctive antibiotics can be used to improve treatment outcomes in patients with severe chronic periodontitis. Antibiotics have been studied extensively in periodontal treatment.

Local drug delivery systems with antibiotics provide several benefits; the drug can be delivered to the site of disease activity at a bactericidal concentration and it can facilitate prolonged drug delivery. Local delivery of antimicrobials in sustained or controlled delivery systems are used to enhance the effect of non-surgical periodontal therapy. It could reduce the risk of adverse events associated with systemic antimicrobials, including the development of bacterial resistance.

Moxifloxacin is a 4th generation fluoroquinolone antibiotic with a broad antimicrobial activity against aerobic and anaerobic bacteria. It exerts excellent antibacterial activity against a wide range of putative periodontal pathogens. It penetrates well into soft tissues and is effective against intracellular periodontal pathogens.1

Ofloxacin is a quinolone antibiotic modified to include anaerobic bacteria in its antibacterialspectrum. They are considered bactericidal and shows strong antibacterial effects on a wide spectrum of bacteria associated with periodontal disease.

There are few studies in the literature comparing the effectiveness of moxifloxacin and ofloxacin. Thus the present study is designed to investigate and compare the effectiveness of subgingivally delivered antimicrobial 0.4% moxifloxacin gel and 0.1% ofloxacin gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.

6.2 REVIEW OF LITERATURE:

A comparative study of scaling and root planing plus varying concentrations of moxifloxacin gel against scaling and root planing alone was done and authors found more favorable results with adjunctive use of 0.4% moxifloxacin gel as a controlled drug delivery system enhancing the clinical and microbiological results as shown by the intergroup comparison after three months.1

Another study which included 46 patients in whom two teeth with deep periodontal pockets each from a different quadrant were randomly assigned to be treated with PT-01 containing ofloxacin and the control site. Clinical measurements were taken at every weekly visit after anti- microbial application. Plaque index, gingival index, bleeding on probing and probing depth decreased significantly.2

A study was done in 102 subjects with severe chronic periodontitis. The subjects of the test group had moxifloxacin on the day of full mouth scaling and root planing as against the control group who underwent scaling and root planing directly. It was shown that full mouth scaling and root planing using systemically administered moxifloxacin was clinically and bacteriologically useful basic periodontal treatment for severe chronic periodontitits.3

Anvitro study on the antimicrobial susceptibility of oral strains of Actinobacillus actinomycetemcomitans to seven antibiotics showed that due to favorable pharmacokinetics, the fluoro-quinolone moxifloxacin appeared to be a promising candidate for adjunctive systemic antibiotic therapy in periodontal infections with A.actinomycetemcomitans.4

A total of 12volunteers who had more than 4 deep periodontal pockets of 4-6 mm in depthwere selected for administration site of ofloxacin as PT-01 or aqueous solution. When PT-01 was inserted, the ofloxacin level in GCF immediately reached a peak, and gradually decreased until the 3rd day, andmaintained a constant level,the effective minimum antibacterial concentration for periodontopathic microorganisms, from the 3rd to 7th day after insertion. The results suggested that ofloxacin was a suitable periodontal chemotherapeutic agent.5

6.3 OBJECTIVES OF THE STUDY:

To compare the effectiveness of 0.4% moxifloxacin gel and 0.1% ofloxacin gel when used as an adjunct to scaling and root planing in a randomized split mouth double blind clinical study.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

A total of 62 patients attending the Department of Periodontics, M.S. Ramaiah Dental College and Hospital, Bangalore will be selected. This is a single center randomized double blind clinical trial study.

INCLUSION CRITERIA:

· Patients in age group between 30-75 years with more than 12 natural teeth present.

· Patients having probing depth ranging between 5-7mm in different quadrants of the mouth.

· Patients who have not undergone any periodontal therapy in the previous 6 months.

· Patients who has not taken any antibiotic, steroids and non-steroidal anti-inflammatory drugs which may influence the periodontium in last 6 months.

EXCLUSION CRITERIA:

· Patients with known or suspected allergy to quinolones which is prescribed in this study.

· Existing systemic disease that may influence the severity or progression of periodontitis,in particular Down Syndrome, HIV infection, or diabetes mellitus type 1 or type 2.

· Patients who are medically compromised.

· Pregnant or lactating women.

· Patients with smoking habit.

· Sites with overhanging restoration.

7.2 STUDY DESIGN :

Ø RANDOMIZATION :

· Patients will be randomized using computer generated random number table.

· Site 1 and Site 2 will be pre-determined and drug A and drug B will be decided by an examiner.

Ø MASKING :

· The trial is conducted in a double blinded manner.

· Neither patients nor the operator involved in rendering the treatment and collecting data is aware of the treatment allocation.

62 OPD patients

Detailed case history + informed consent taken

All patients receive oral prophylaxis with oral hygiene instructions

1 week later

Sites with probing depth > 5 mm taken

Occlusal stents will be fabricated for standardization of clinical measurements and used as a FIXED REFERENCE POINT (FRP)

Plaque Index, Gingival Index, Modified Sulcus Bleeding Index, Probing pocket depth and Clinical Attachment Level recorded( BASELINE MEASUREMENT)-using UNC-15 probe (Hu Friedy's)

Single dose of investigational gel applied into the periodontal pocket by an operator using a syringe with a blunt cannula

Post treatment evaluation & Follow Up

3 months

6 months

9 months

· DRUGS USED IN THE STUDY

1. MOXIFLOXACIN 0.4% gel

2. OFLOXACIN0.1% gel

· Experimental GroupA: SCALING AND ROOT PLANING [SRP] +subgingivally delivered 0.4% moxifloxacin gel into periodontal pockets.

· Experimental GroupB: SCALING AND ROOT PLANING [SRP] + subgingivally delivered 0.1 % ofloxacin gel into periodontal pockets.

Clinical Parameters which would be assessed are:

a. Plaque index(PI)-Silness Loe (1964)

b. Modified Sulcus Bleeding index –A. Mombelli, M.A. Van Oosten, E. Schurch, Jr. N.P. Land

c. Gingival index – Loe H & Silness (1963)

d. Clinical attachment level (CAL)-measured using an acrylic stent (FRP to BOP – FRP to CEJ)

Probing pocket depth (PPD)-measured using UNC 15 probe (FRP to BOP –FRP to GM)

FRP-Fixed reference point.

BOP-Base of the pocket.

GM-Gingival margin

CEJ-Cemento enamel junction

FOLLOW UP:

Follow up will be done at baseline, 3, 6 and 9 months respectively for measuring the clinical parameters.

STATISTICAL TESTS:

All the parameters will be evaluated at baseline, 3, 6 and 9 months period and compared with base line data using student t test.

7.3 Does the study require any investigation or intervention to be conducted on patients or other human or animal?

YES.

Local Delivery Antimicrobial 0.4% MOXIFLOXACIN GEL & 0.1% OFLOXACIN GELS will be used in the study.

8. LIST OF REFERENCES:

1. Flemmig T, Petersilka G, Volp A, Gravemeier M, Zilly M, Mross D. Efficacy and Safety of Adjunctive Local Moxifloxacin Delivery in the Treatment of Periodontitis. J Periodontol 2011;82:96-105.

2. Hiroshi Yamagami, Akira Takamori, Tadayuki Sakamoto, and Hiroshi Okala. Intrapocket Chemotherapy in Adult Periodontitis Using a New Controlled-Released Insert Containing Ofloxacin (PT-01).J Periodontol 1992; 63:2-6.

3. Guentsch A, Jentsch H, Pfister W, Hoffmann T, Eick S. Moxifloxacin as an Adjunctive Antibiotic in the Treatment of Severe Chronic Periodontitis. J Periodontol 2008;79:1894-1903.

4. Muller H.P, Holderrieth S, Burkhardt U, Hoffler U. In vitro antimicrobial susceptibility of oral strains of Actinobacillus actinomycetemcomitans to seven antibiotics.J Clin Periodontol 2002;29:736-42

5. Higashi K, Morisaki K, Hayashi S, Kitamura M, Fujimoto N, Kimura S. Local ofloxacin delivery using a controlled-release insert (PT-01) in the human periodontal pocket. J Periodont Res 1990: 25:1-5.

6. Milazzo I, Blandino G, Musumeci R, Nicoletti G ,LoBue AM, Speciale A. Antibacterial activity of moxifloxacin against periodontal anaerobic pathogens involved in systemic infections. Int J Antimicrob Agents 2002; 20:451-56.

7. Eick S, Pfister W. Efficacy of antibiotics against periodontopathogenic bacteria within epithelial cells:An in vitro study. J Periodontol 2004;75:1327-34.

8. JoergW.Kleinfelder, Ruediger F. Mueller, and Dieter E. Lange. Fluoroquinolones in the treatment of Actinobacillus actinomycetemcomitans-Associated Periodontitis. J Periodontol 2004;71:202-08.

M.S.RAMAIAH DENTAL COLLEGE AND HOSPITAL, BANGALORE

DEPARTMENT OF PERIODONTICS

PROFORMA

NAME OF THE PATIENT: AGE: SEX: M/F

O.P NO:

OCCUPATION:

ADDRESS & PHONE NO:

SITES SELECTED FOR THE STUDY:

PLAQUE INDEX ( SILNESS AND LOE)

FOR SELECTED TEETH

D M D M

16 12 24 36 32 44

SCORE=

INTERPRETATION-Excellent/Good/Fair/Poor

GINGIVAL INDEX (LOE & SILNESS)

FOR SELECTED TEETH

D M D M

16 12 24 36 32 44

SCORE=

INTERPRETATION-

MODIFIED SULCUS BLEEDING INDEX

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

SCORE=

CONTROL SITE/ EXPERIMENTAL SITE

MEASUREMENTS (in mm)

Sr.
No / MEASUREMENTS / BASELINE / 3 MONTHS / 6 MONTHS / 9 MONTHS
1 / Plaque index (total score)
2 / Gingival index (total score)
3 / Pocket depth :
FRP to BOP – FRP to GM
4 / Clinical attachment level:
FRP to BOP- FRP to CEJ
5 / Bleeding Index

FRP – Fixed reference point. GM – Gingival margin

BOP – Base of the pocket. CEJ – Cemento enamel junction

CONSENT FORM

I consent to the recommended procedure or treatment ……………………………………………………………………………………………………………………………………………………………… to be completed by Dr. ______

The procedure(s) or treatment(s) have been described to me.

I have been informed of the purpose of the procedure or treatment.

I have been informed of the alternatives to the procedure or treatment.

I understand that the following risk(s) may result from the procedure or treatment:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

I understand that the following risk(s) may occur if the procedure or treatment is not completed:

I do – do not – consider to the administration of anesthetic.

a) I understand that the following risks are involved in administering anesthesia:

b) The following alternatives to anesthesia were described:

All my questions have been satisfactorily answered.

Signature: ______

Date

Representative: ______

Date

Signature of Witness: ______

Date