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CTRI Number  CTRI/2024/03/064254 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of low level laser therapy and scaling and root planing on Superoxide Dismutase Levels 
Scientific Title of Study   EVALUATION OF EFFICACY OF LOW LEVEL LASER THERAPY AND SCALING AND ROOTPLANING ON SERUM SUPEROXIDE DISMUTASE LEVELS-A PROSPECTIVE CLINICAL STUDY. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinitha Saravanan 
Designation  post graduate student 
Affiliation  Sharavathi dental college and hospital 
Address  Department of Periodontology Sharavathi dental college and hospital Shimoga

Bangalore
KARNATAKA
577205
India 
Phone  7795640184  
Fax    
Email  vinitha2212@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Soumya BG 
Designation  professor 
Affiliation  Sharavathi dental college and hospital 
Address  Department of periodontology Sharavathi dental college and hospital Shimoga

Bangalore
KARNATAKA
577205
India 
Phone  7795640184  
Fax    
Email  drbgsoumya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Vinitha Saravanan 
Designation  post graduate student 
Affiliation  Sharavathi dental college and hospital 
Address  Department of periodontology Sharavathi dental college and hospital

Bangalore
KARNATAKA
577205
India 
Phone  7795640184  
Fax    
Email  vinitha2212@gmail.com  
 
Source of Monetary or Material Support  
Sharavathi dental college and hospital,Shimoga 
 
Primary Sponsor  
Name  Vinitha Saravanan 
Address  Sharavathi dental college and hospital.Shimoga.Karnataka 
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 Vinitha Saravanan  Sharavathi dental college  room number-7,second floor Department of periodontology NH 206, Alkola,T.H Road, Karnataka 577205
Shimoga
KARNATAKA 		 7795640184

vinitha2212@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sharavathi ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Patients with chronic generalized periodontitis 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  SRP and SRP and photobiomodulation therapy  one group of patients undergo scaling and root planing while the other group undergoes scaling and root planing along with photobiomodulation therapy total duration is 21days 
Comparator Agent  SRP vs SRP with PBM  SRP and SRP along with PBM(low level laser therapy) for 3 sessions over a period of 48 hours  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients suffering from stage II Grade A periodontitis
2) Possessing atleast 20 teeth
3) Probing pocket Depth PPD of atleast ≥ 5mm
 
 
ExclusionCriteria 
Details  1) Current smokers
2) Patients having undergone surgical or non-surgical periodontal therapy in the past 6 months.
3) Patients on antibiotic or anti-inflammatory medication.
4) Patients on anti-oxidant supplements
5) Patients with systemic conditions.
6) Pregnant and lactating mothers.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
reduction in the levels of super oxide dismutase after treatment in both the groups  day 1
after 21 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in levels of oxidative stress in both groups  21 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial
Modification(s)  		 N/A 
Date of First Enrollment (India)   10/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vinitha2212@gmail.com].

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 26-04-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study consists of a total of 30 participants divided into two groups of 15 each by the coin toss method. One group is treated with scaling and root planing while the second group is treated with scaling and root planing followed by photobiomodulation therapy with low level laser at 660nm wavelength for a duration of 40 seconds. Blood samples are drawn at the first and 21st day to analyse the levels of superoxide dismutase in the serum.  
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