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CTRI Number  CTRI/2016/03/006700 [Registered on: 03/03/2016] Trial Registered Retrospectively
Last Modified On: 02/03/2016
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   to check the effect of gum treatment on the blood lipid levels of individuals having altered lipid levels 
Scientific Title of Study   EVALUATION OF THE EFFECT OF PERIODONTAL THERAPY ON SERUM LIPID LEVELS IN CHRONIC PERIODONTITIS PATIENTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jasmine Malhotra 
Designation  post graduate student 
Affiliation  Manipal college of dental sciences 
Address  room no. 3, dept of periodontology MCODS

Udupi
KARNATAKA
576104
India 
Phone  7760598367  
Fax    
Email  jmjasminemalhotra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pratibha PK 
Designation  additional professor 
Affiliation  Manipal college of dental sciences 
Address  room no. 3, dept of periodontology MCODS

Udupi
KARNATAKA
576104
India 
Phone  9448724121  
Fax    
Email  bg_pratibha@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Pratibha PK 
Designation  additional professor 
Affiliation  Manipal college of dental sciences 
Address  room no. 3, dept of periodontology MCODS

Hassan
KARNATAKA
576104
India 
Phone  9448724121  
Fax    
Email  bg_pratibha@yahoo.co.in  
 
Source of Monetary or Material Support  
jasmine malhotra (primary investigator) 
 
Primary Sponsor  
Name  Jasmine Malhotra 
Address  room no. 3, department of periodontology, MCODS, Manipal 
Type of Sponsor  Other [primary investigator] 
 
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 
jasmine malhotra  manipal college of dental sciences  room no. 3, dept of periodontology MCODS
Udupi
KARNATAKA 		 7760598367

jmjasminemalhotra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba hospital, manipal institutional ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  chronic periodontital disease with hypercholesteromia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  complete periodontal therapy  supragingival scaling as well as demonstration of Modified Bass method of brushing were carried out. They were recalled after fifteen days for subgingival scaling and root planing. This was done quadrant wise and completed within a 24 hour period. Following this, the patients received curettage or open flap debridement, based on clinical judgement, after a 15 day follow up period. After completion of treatment of all periodontally involved areas, the patients were kept on regular recall (1-2 months) and advised to continue with the Modified Bass method of brushing with emphasis on interdental plaque control.  
Comparator Agent  supragingival scaling  supra gingival scaling was done at the initial visit. Patients were demonstrated Modified Bass method of brushing and advised use of interdental aids. No further treatment was carried out till three months 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The inclusion criteria consisted of patients having altered lipid profile i.e. the patients having hypercholesterolemia and falling under the moderate risk or low risk and those that can be treated by Therapeutic Lifestyle Changes (TLC) only (as given by American heart association ATP III guidelines. Patients should not be on any cholesterol lowering drugs and otherwise systemically healthy patients within the age group of 30-65 yrs. Patients with pocket probing depth ≥5 mm with clinical attachment loss of ≥1 mm (≥2quadrants). Presence of a minimum of 20 teeth was obligatory for inclusion in the clinical trial.  
 
ExclusionCriteria 
Details  patients having history of any systemic disease like renal, hepatic, cardiac, diabetes, immunological or haematological disorders with contra-indication for minor oral surgical procedure, pregnant women, patients on chemotherapeutic agents in the previous 3 months or oral antiseptics in the previous month, previous periodontal treatment over the past six months, patients on estrogen replacement therapy and patients on folic acid or vitamin B6 or B12. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
decrease in clinical periodontal parameters and serum lipid profile parameters   baseline and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
decrease in resistin, BMI and waist-hip ratio  baseline and 3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/05/2013 
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="3"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The patients meeting the inclusion criteria were divided into 2 groups: test and control group. the test group received complete periodontal therapy consisting of supra ginval, sub gingival scaling, root planing and open flap debridement. the control group underwent only supragingival scaling. the clinical periodontal parameters, lipid profile parameters, resistin levels, BMI and waist hip ratio were evaluated at baseline and 3 months post periodontal therapy. 
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