| CTRI Number |
CTRI/2025/12/099462 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effect of Ozonized Water Used During Dental Scaling on Gum Health in Patients with Advanced Gum Disease |
|
Scientific Title of Study
|
Effect of irrigation with ozonized water during ultrasonic scaling in the management of periodontitis: A randomized controlled clinical trial. |
| 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 Niranjana J Mohan |
| Designation |
Assistant Professor,Department of Periodontics, PMS College of Dental Science and Research, |
| Affiliation |
Department of Periodontics, PMS College of Dental Science and Research, |
| Address |
Hridyam, Kalady, Karamana PO, Trivandrum
Golden Hills, Vattappara,
Thiruvananthapuram, Kerala – 695028, India.
Thiruvananthapuram
KERALA
695002
India |
| Phone |
7907153733 |
| Fax |
|
| Email |
ninjujm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atheesh K R |
| Designation |
Final year student , BDS |
| Affiliation |
Pms College of Dental Science and Research |
| Address |
Golden Hills, Vattappara,
Thiruvananthapuram, Kerala – 695028, India.
Thiruvananthapuram
KERALA
695002
India |
| Phone |
7907153733 |
| Fax |
|
| Email |
ninjujm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NIRANJANA J MOHAN |
| Designation |
Assistant Professor,Department of Periodontics, PMS College of Dental Science and Research, |
| Affiliation |
Assistant Profess PMS College of Dental Science and Research, |
| Address |
HRIDYAM MARWELB75,KULATHARA, KALADY ,KARAMANA PO, TRIVANDRUM 2, KERALA
Golden Hills, Vattappara,
Thiruvananthapuram, Kerala – 695028, India.
KERALA
695002
India |
| Phone |
7907153733 |
| Fax |
|
| Email |
ninjujm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Organization: Indian Council of Medical Research (ICMR)
Building: V. Ramalingaswami Bhawan, Ansari Nagar
City/Pin Code: New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
ICMR STS |
| Address |
Division of HRD, Indian Council of Medical Research Headquarters, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Government funding agency |
|
|
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 Niranjana |
PMS College of Dental Science and Research |
Department of Periodontics,Golden Hills, Vattapara, Venkode, Thiruvananthapuram, Kerala 695028
Thiruvananthapuram
KERALA |
7907153733
ninjujm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NORMAL SALINE |
Route of administration-Subgingival irrigation
Concentration - 0.9% w/v
Duration- 20 seconds per tooth
Total duration- 20 mins |
| Intervention |
OZONIZED WATER |
Route of administration-Subgingival irrigation
Concentration - 2 ppm
Duration- 20 seconds per tooth
total duration 20 mins
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Stage III periodontitis (diagnosed according to 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions)31
Patients with minimum of 20 remaining teeth
Subjects with PPD greater than or equal to 5mm in at least one site /quadrant.
Subjects who had not received periodontal therapy within the last 6 months.
Those who were willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients with Stage III periodontitis (diagnosed according to 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions)31
Patients with minimum of 20 remaining teeth
Subjects with PPD greater than or equal to 5mm in at least one site /quadrant.
Subjects who had not received periodontal therapy within the last 6 months.
Those who were willing to participate in the study |
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Results OF indices like Plaque Index (Turesky- Gilmore-Glickman modification of Quigley –Hein), Gingival Index (Loe and Silness), Periodontal Pocket Depth (PD), Clinical attachment level (CAL), gingival recession and bleeding on probing (BOP). |
1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Results of biochemical analysis of saliva |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ninjujm@gmail.com].
- For how long will this data be available start date provided 19-11-2025 and end date provided 20-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This randomized controlled clinical trial investigates the efficacy of ozonized water irrigation compared to normal saline during ultrasonic scaling in the management of periodontitis. The study aims to evaluate clinical improvements in periodontal parameters specifically probing pocket depth and clinical attachment level as well as biochemical changes reflected by salivary interleukin 1 beta IL 1 beta levels. Conducted in a tertiary care setting over one year the trial includes 60 participants aged 30 to 60 years diagnosed with Stage III periodontitis. Subjects are randomly allocated into two groups Group A receives ozonized water irrigation and Group B receives normal saline irrigation during scaling. Clinical and biochemical assessments are performed both before and after treatment. The study hypothesizes that ozonized water irrigation provides superior improvement in periodontal health and exhibits enhanced anti inflammatory effects compared to normal |