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CTRI Number  CTRI/2024/08/072049 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Ozone and Photodynamic Therapy as Adjuncts to Scaling and Root Planing in Chronic Periodontitis: A Comprehensive Evaluation 
Scientific Title of Study   A comparative study of ozone therapy and photodynamic therapy as an adjunct to scaling and root planing in chronic periodontitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpi Mangal 
Designation  Post Graduate Student 
Affiliation  King Georges Medical University 
Address  Department of Periodontology Faculty of Dental Sciences King Georges Medical University Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  8979217080  
Fax    
Email  shilpimngl6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Shalini Kaushal 
Designation  Professor 
Affiliation  King George Medical University 
Address  King George Medical University Department of Periodontology Faculty of Dental sciences Lucknow
King George Medical University Department of Periodontology Faculty of Dental sciences Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9450454408  
Fax    
Email  shalinikaushal@kgmcindia.edu  
 
Details of Contact Person
Public Query  
Name  Shilpi Mangal 
Designation  Post Graduate Student 
Affiliation  King Georges Medical University 
Address  Department of Periodontology Faculty of Dental Sciences King Georges Medical University Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  8979217080  
Fax    
Email  shilpimngl6@gmail.com  
 
Source of Monetary or Material Support  
King George Medical University, Lucknow, Uttar Pradesh, India -226003 
 
Primary Sponsor  
Name  Shilpi Mangal 
Address  Department of Periodontology Faculty of Dental Sciences King Georges Medical University Lucknow 
Type of Sponsor  Other [Self - Principle 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 
Dr Shilpi Mangal  King George Medical University  Department of Periodontology Faculty of Dental Sciences King Georges Medical University Lucknow
Lucknow
UTTAR PRADESH 		 8979217080

shilpimngl6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University Institutional Ethics Committee Lucknow  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  Ozone Therapy and Photodynamic Therapy  Ozonated water in a concentration of 80 microgram/ml for 5-10 minutes after full mouth scaling and root planing .Ozone therapy has to be given at baseline and at 1 month. For photodynamic therapy-Indocyanine dye in 0.05 miligram/ml for 30 seconds and exposure with low level laser for 1 minute in non contact continuous wave mode after full mouth scaling and root planing . Photodynamic therapy has to be given at baseline and at 1 month . 
Comparator Agent  Scaling and root planing   Only full mouth scaling and root planing.Scaling and root planing will be performed at baseline and at 1 month.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Generalized chronic periodontitis patients when equal to or greater than 30 percentage of the sites are affected by the disease , probing depth equal to or greater than 5 mm , clinical attachment level equal to or greater than 4 mm in at least 10 percentage of sites , no gender discrimination  
 
ExclusionCriteria 
Details  Smokers , history of systemic diseases that can alter the course of the periodontal disease , history of periodontal therapy in the last 6 months , history of taking antibiotics or any form of antioxidant therapy within the last 3 months , pregnant women or women in the lactation period , patient who are allergic to photosensitizer dye . 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Gingival Index , Plaque Index , Periodontal pocket depth and Clinical attachment level  Baseline,1 month & 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Microbiological assessment in terms of Colony forming units and Biochemical marker analysis IL-1beta and Pentraxin 3  Baseline , 1 month and 3 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/08/2024 
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="1"
Months="6"
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 - NO
Brief Summary   The main goal of periodontal therapy is to arrest the inflammatory disease process and allow the regeneration of the lost periodontium. Scaling & root planing is the gold standard non surgical periodontal treatment but not completely eliminate the residual pockets & bacteria , particularly at the furcation , root concavities , interproximal areas & sites with deepest pocket that are inaccessible to periodontal instruments ,  so adjunctive therapies are required .Among the available non surgical therapies to achieve the better plaque control , ozonated water therapy & photodynamic therapies are being widely recognized as two available techniques .The unique properties , non invasive nature , versatility makes both of them as an effective tool in the treatment of periodontitis .Ozone is very effective in antibiotic resistant strains. Adjunctive use of LASERS in non surgical therapy is one of the upcoming potential treatment strategies & antibacterial effect of lasers may be enhanced by the inclusion of a photosensitizing dye, Indocyanine ,exhibiting a 20 % photodynamic effect  & its main action is through photothermal effect. 
This study will evaluate & compare the clinical parameters , microbial load & biochemical markers IL-1beta & pentraxin 3  in chronic periodontitis patients of ozone therapy, photodynamic therapy & scaling & root planing at baseline , 1 month & 3 months. The patients of chronic periodontitis will be selected from the Department of Periodontology ,King George Medical University . 

After eliglbility checking according to the inclusion & exclusion criteria , patient will be allocated in Group A ,B , C respectively by lottery method. The entire procedure will be explained to the patients & signed informed consent will be obtained .All clinical parameters will be recorded at baseline(first time the patient reports) before scaling & root planing with a standard UNC 15 Probe. 

Group A will be only be given full mouth scaling & root planing 
Group B will undergo full mouth scaling & root planing along with ozone therapy 
Group C will undergo full mouth scaling & root planing along with photodynamic therapy 

Deepest pocket site of group B Will be irrigated subgingivally with ozonated water in a concentration of 80 microgram / ml with 22 gauge needle for  5-10 minutes after full mouth scaling and root planing & Group C patient will be delivered Indocyanine dye ,0.05 miligram / ml with 22 gauge needle for 30 seconds & the sites will be exposed to low level laser for 1 minute in non contact continuous wave mode after full mouth scaling & root planing.

For Microbiological assessment , sampling sites first isolated using cotton rolls & supragingival plaque will be removed with the help of sterile cotton pellets , subgingival plaque samples from the maximum pocket depth  will be collected from the sterile curette & transported in an anerobic transport medium & will be cultured on Wilkins Chalgran anerobic agar prepared by the standard protocol & incubated in anerobic gas pack jar ,bacterial identification will be done by Matrix assisted laser desorption ionization time of light (MALDI-TOF MS), biomerieux. Semiquantitative estimation will be done by counting the colony forming units. 

For Biochemical marker, GCF sample will be collected with the help of absorbent paper point. Paper point will be inserted into the deepest pocket from 2-3 sites for 30 seconds until resistance  is felt & then placed into the eppendorf tube containing phosphate buffer solution & then analyzed with the help of ELISA Kit according to the manufacture’s instructions.

 
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