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CTRI Number  CTRI/2024/05/067305 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Checking of malondialdehyde levels using tinospora cordifolia oil as an addition to cleaning of teeth for the treatment of gum disease. 
Scientific Title of Study   Evaluation of salivary malondialdehyde levels in chronic periodontitis patients treated with tinospora cordifolia oil as an adjunct to scaling and root planing. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pothavarjula Satyasri 
Designation  Post Graduate student 
Affiliation  Sibar Institute of Dental Sciences 
Address  Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur

Guntur
ANDHRA PRADESH
522509
India 
Phone  9491430741  
Fax    
Email  satyasripothavarjula@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Kishore kumar 
Designation  Professor 
Affiliation  Sibar Institute of Dental Sciences, Guntur 
Address  Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur

Guntur
ANDHRA PRADESH
522509
India 
Phone  9000534590  
Fax    
Email  kishoreuga@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr K Kishore kumar 
Designation  Professor 
Affiliation  Sibar Institute of Dental Sciences, Guntur 
Address  Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur

Guntur
ANDHRA PRADESH
522509
India 
Phone  9000534590  
Fax    
Email  kishoreuga@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur 522509 India 
 
Primary Sponsor  
Name  Pothavarjula Satyasri 
Address  Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur 522509 
Type of Sponsor  Other [self] 
 
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 K Kishore Kumar  Sibar Institute of Dental Sciences  Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur 522509
Guntur
ANDHRA PRADESH 		 9000534590

kishoreuga@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sibar Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tinospora cordifolia oil   Patients will receive tinospora cordifolia oil application along with scaling and root planing and patients will be followed up for 3 months for evaluating clinical parameters  
Comparator Agent  without Tinospora Cordifolia oil  patients will receive scaling and root planing alone and patients will be followed up for 3 months for evaluating clinical parameters 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Age group 25-55 years.
2. Subjects who are apparently healthy.
3. Probing pocket depth and clinical attachment level of 4-6 mm
4. Radiographic evidence of horizontal bone loss.
5. Subjects who are willing to give informed consent for the study. 
 
ExclusionCriteria 
Details  1. Radiographic evidence of vertical bone loss.
2. Subjects who has history of drug allergy.
3. Any form of tobacco consumption.
4. Pregnancy or lactating females.
5. History of any form of periodontal therapy in the past 1 year. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate salivary MDA levels at baseline
and 3 months after SRP with and without Tinospora cordifolia oil application.  		 To evaluate salivary MDA levels at baseline
and 3 months after SRP with and without Tinospora cordifolia oil application.  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate periodontal parameters (PI, GI, PD, CAL) at baseline
and 3 months after SRP with and without Tinospora cordifolia oil application 		 baseline and 3 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/06/2024 
Date of Study Completion (India) 31/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   At initial visit, patients will be assessed for eligibility.36 patients will be selected based on inclusion and exclusion criteria. All the patients will receive phase-1 therapy, consists of supra gingival scaling using ultrasonic scaler and followed by oral hygiene instructions. All the patients will be recalled after 14 days for measurement of baseline parameters of PI (score≤1), GI, PPD, CAL and unstimulated saliva will be collected for measurement of sMDA levels. patients will be randomised into 2 groups. Patients in group I will receive Tinospora cordifolia oil application along with SRP whereas group II patients will receive SRP alone. Analgesics will be prescribed to take twice daily at morning and evening after food for 3 days and post operative instructions will be given to all patients. Patients will be recalled after 3months. All the clinical parameters will be recorded and saliva samples collection will be done 3 months postoperatively. 
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