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CTRI Number  CTRI/2025/03/083548 [Registered on: 26/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the effects of ozone water vs regular water on gum health after cleaning in gum disease. 
Scientific Title of Study   Comparative evaluation of ozonized water irrigation vs non ozonized water irrigation after mechanical debridement on clinical parameters in stage II/III periodontitis: A randomized control 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  Dr Abha Satyendranath Chavan 
Designation  JR 1st year MDS PG 
Affiliation   
Address  Room number 7, Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth,At and Post Piparia, Taluk Waghodia, Vadodara, Gujarat - 391760

Vadodara
GUJARAT
391760
India 
Phone  09146778979  
Fax    
Email  drabhasatyendra30@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasad Nadig 
Designation  Professor  
Affiliation  K M Shah Dental College and Hospital ,Sumandeep Vidyapeeth 
Address  Department no.7,Department of Periodontology,KM Shah Dental College and Hospital,Sumandeep Vidyapeeth,Piparia,Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8469779161  
Fax    
Email  drprasadnadig@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prasad Nadig 
Designation  Professor  
Affiliation  K M Shah Dental College and Hospital ,Sumandeep Vidyapeeth 
Address  Department no.7,Department of Periodontology,KM Shah Dental College and Hospital,Sumandeep Vidyapeeth,Piparia,Waghodia Vadodara

Vadodara
GUJARAT
391760
India 
Phone  8469779161  
Fax    
Email  drprasadnadig@gmail.com  
 
Source of Monetary or Material Support  
room no 7,Department of Periodontology, KM Shah Dental College and Hospital ,Sumandeep Vidyapeeth, Pipariya,Waghodia,Vadodara 
 
Primary Sponsor  
Name  Dr Abha Chavan 
Address  Department no.7,Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth, Pipariya Vadodara 391760 
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 Abha Satyendranath Chavan  K.M Shah Dental College and Hospital , Sumandeep Vidyapeeth.  Room number 7, Department of Periodontology, KM Shah Dental College and Hospital, Sumandeep Vidyapeeth, At and Post Piparia, Taluk Waghodia, Vadodara, Gujarat - 391760
Vadodara
GUJARAT 
8180032045

drabhasatyendra30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  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 
Comparator Agent  Distilled water   Irrigation with distilled water after mechanical debridement for a duration of 1 PPM. 
Intervention  Ozonized water of 1 PPM  Irrigation with ozonized water 1 PPM after mechanical debridement for a duration of 1 month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age between 18 to 60 years of age
Systemically healthy patients
Subjects with minimum 20 natural teeth remaining
Subjects having Stage II and III Periodontitis 
 
ExclusionCriteria 
Details  Patients with systemic disease
Patients consuming any form of tobacco
Pregnant and Lactating women
Having symptoms of acute illness during time of study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pocket Probing Depth, Clinical Attachment Loss, Cumulative Periodontal Sum Score, C Reactive Protein.  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque Index, Modified Sulcular Bleeding Index.  Baseline & 1 month  
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="52" 
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   N/A 
Date of First Enrollment (India)   01/06/2025 
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  

Periodontitis is a long-term gum disease that affects the tissues supporting your teeth, like the gums, ligaments, and bone. It starts with minor bone loss and can worsen over time, leading to serious damage. There are different stages of periodontitis, and Stage II and III are marked by moderate bone loss and signs like deep pockets between your teeth and gums, along with bleeding when you probe the gums.

One way to treat this condition is by flushing out the harmful bacteria in the pockets between the gums and teeth.

Ozone, a form of oxygen with extra energy, has been studied as a possible alternative. It’s thought to be more powerful because it kills bacteria, reduces inflammation, and helps tissues heal faster. Ozone could be especially useful in treating the bacteria that cause periodontitis, like Porphyromonas gingivalis and Tannerella forsythia.

This study is comparing the effectiveness of ozonized water (water with ozone in it) and regular water in treating Stage II and III periodontitis. By looking at things like how much the pockets between the teeth shrink and how much attachment the gums have to the teeth, the study wants to see if ozonized water leads to better results in treating the disease.

 
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