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CTRI Number  CTRI/2016/11/007428 [Registered on: 03/11/2016] Trial Registered Retrospectively
Last Modified On: 29/10/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to know the effect of Simvastatin gel on bone formation 
Scientific Title of Study   Effect of in-situ application of Simvastatin gel in the surgical management of osseous defects in Chronic periodontitis- A clinico-radiographic study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajeev Ranjan 
Designation  Assistant Professor ( Ex P.G student, K.L.E Society Institute of Dental Sciences- Bangalore) 
Affiliation  Kalinga Institute of Dental Sciences (Present Affiliation)  
Address  Kalinga Institute of Dental Sciences, Department of Periodontics and Oral Implantology, Campus-5, KIIT University, Patia, Bhubaneswar (Odisha) (Present Affiliation)

Khordha
ORISSA
751024
India 
Phone  9090378927  
Fax    
Email  ranjan.rajeev_84@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SUDHIR R PATIL 
Designation  PROF. AND H.O.D 
Affiliation  K.L.E Societys Institute of Dental Sciences 
Address  Department of Periodontics, K.L.E Societys Institute of Dental Sciences, Number 20, Tumkur road, Yeshavanthpur suburbs, Bangalore

Bangalore
KARNATAKA
560022
India 
Phone  9845560110  
Fax    
Email  zonaperio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajeev Ranjan 
Designation  Assistant Professor (Ex P.G student of K.L.E Society Institute of Dental Sciences- Bangalore) 
Affiliation  Kalinga Institute of Dental Sciences (Present Affiliation) 
Address  Kalinga Institute of Dental Sciences, Department of Periodontics and Oral Implantology, Campus 5, KIIT University, Patia-Bhubaneswar (Odisha) (Present Affiliation)

Khordha
ORISSA
751024
India 
Phone  9090378927  
Fax    
Email  ranjan.rajeev_84@yahoo.com  
 
Source of Monetary or Material Support  
K.L.E Society Institute of Dental Sciences, 20, Tumkur Main Road, Yeshwanthpur Suburb 2nd Stage, Raja Industrial Estate, Yeshwanthpur, Bengaluru, Karnataka 560022 
 
Primary Sponsor  
Name  KLE Society Institute of Dental Sciences 
Address  Number 20, Tumkur road, Yeshavanthpur suburbs, Bangalore,India 560022 
Type of Sponsor  Other [Private Dental college and Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajeev Ranjan  K.L.E Society Institute of Dental Sciences, Bangalore  Department of Periodontics and Oral Implantology, Number 20, Yeshwanthpur Suburb, II Stage, Tumkur Road, Bangalore - 560 022.
Bangalore
KARNATAKA 		 9090378927

ranjan.rajeev_84@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
K.L.E SOCIETYS INSTITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients suffering from Chronic Periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A was the treatment group   20 patients contributing 40 sites (Split mouth) were recruited for study from the OPD of Department of Periodontics, K.L.E Societys institute of Dental sciences- Bangalore. Randomly selected sites were categorized into two treatment group, Group 1 (treatment group) where 1.2 mg/0.1ml Simvastatin containing carbopol gel was applied after surgical debridement of periodontal defect and Group 2 (control group) where only placebo gel was applied after surgical debridement of periodontal defect. Total duration of study was 9 months and clinical and Radiographic parameters were recorded at the end of 3, 6 and 9 months. 
Comparator Agent  Group B was the control group where placed gel applied at surgical site  Only placebo gel applied at defect site 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  • Systemically healthy patient diagnosed with generalised chronic periodontitis
• Clinical probing pocket depth ≥ 5 mm.
• Radiographic evidence of bilateral intrabony defects in mandibular molar region
 
 
ExclusionCriteria 
Details  - History of antibiotics in last 6 months
- History of periodontal therapy in last 6 months
- Suspected allergy to statin group
- Patients on systemic statin therapy
- Patients having Aggressive periodontitis
- Current smokers
- Immunocompromised patient
- Pregnant and lactating females
- Patients having any bleeding disorders
- Any other contraindication for periodontal surgery
- Patients indicated for multiple extractions/undergone multiple extractions
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Amount of bone fill and percentage of original defect fill in Group 1 was statistically highly significant than Group 2 at the end of 6 and 9 months.   3 months, 6 months and 9 months.  
 
Secondary Outcome  
Outcome  TimePoints 
Both group resulted in significant improvement of both clinical and radiological parameters. There was significant reduction of Gingival Index (GI) , Probing pocket Depth (PPD) and gain in Clinical attachment level (CAL) was observed at the end of 3.6 and 9 months.   3 months, 6 months and 9 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/04/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The present was conducted to evaluate the periodontal tissue response to in-situ gel using simvastatin with carbolopol 934 p (as a vehicle) after surgical debridement of periodontal osseous defects by recording various clinical parameters , Gingival index (GI), Probing pocket depth (PPD) , Plaque index (PI) and Clinical attachment level (CAL ) and Radiographic paramers (Bone fill) at the end of 3 months, 6 months and 9 months. 

Results of this studied showed improvement in both clinical and radiographic parameters in both experiment (Group 1) and Control group (Group 2). But, improvement in clinical and Radiographic parameters (Amount of bone fill) in experiment group was statistically highly significant than control group. Results of this study was in accordance with previously conducted study by Pradeep A.R et al - 2010 and Stein D et al 2005. Various studies e.g Mundy et al 1999, Yazawa H et al 2005,Nyan M et al 2007   have also shown the bone anabolic effect of Simvastatin. 

This study has concluded that Simvastatin  as a non space occupying host modulatory pharmacologic agent in the form of in-situ gel as an adjunct to mechanical and surgical treatment approaches may be the future potential application in regenerative periodontal therapy. However, more randomized controlled trial with long term followup to be conducted to proclaim the observations of this study.
 
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