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
|
|
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
|
|
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. |