| CTRI Number |
CTRI/2020/07/026275 [Registered on: 01/07/2020] Trial Registered Prospectively |
| Last Modified On: |
25/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF USING OZONIZED WATER FOR TEETH CLEANING(DENTAL THERAPY) IN TREATMENT OF GUM DISEASE |
|
Scientific Title of Study
|
EFFECT OF IRRIGATION WITH OZONIZED WATER DURING ULTRASONIC SCALING IN MANAGEMENT OF PERIODONTITIS- A RANDOMISED CONTROLLED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIRANJANA J MOHAN |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
MARWEL B 75 ,"HRIDYAM", KULATHARA JUNCTION, KALADY, KARAMANA PO
TRIVANDRUM
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH,Golden Hills, Vattapara, Venkode, Thiruvananthapuram, Kerala 695028
Thiruvananthapuram
KERALA
695002
India |
| Phone |
7907153733 |
| Fax |
|
| Email |
niranjanajmohan@hotmaill.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMBILI R |
| Designation |
PROFESSOR,DEPARTMENT OF PERIODONTICS |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH,Golden Hills, Vattapara, Venkode, Thiruvananthapuram, Kerala 695028
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH,Golden Hills, Vattapara, Venkode, Thiruvananthapuram, Kerala 695028
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
|
| Email |
ambilirenjith2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NIRANJANA J MOHAN |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
| Address |
MARWEL B 75 ,"HRIDYAM", KULATHARA JUNCTION, KALADY, KARAMANA PO
TRIVANDRUM
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH,Golden Hills, Vattapara, Venkode, Thiruvananthapuram, Kerala 695028
Thiruvananthapuram
KERALA
695002
India |
| Phone |
7907153733 |
| Fax |
|
| Email |
niranjanajmohan@hotmaill.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTION- PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH, TRIVANDRUM |
| INVESTIGATOR-
NIRANJANA J MOHAN |
|
|
Primary Sponsor
|
| Name |
NIRANJANA J MOHAN |
| Address |
MARWEL B 75 , HRIDYAM ,KULATHARA JUNCTION, KALADY, KARAMANA PO, TRIVANDRUM,KERALA PIN 695002 |
| Type of Sponsor |
Other [INVESTIGATOR/other] |
|
|
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 |
| NIRANJANA J MOHAN |
PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
Golden Hills, Vattapara, Venkode, Thiruvananthapuram, Kerala 695028
Thiruvananthapuram
KERALA |
7907153733
niranjanajmohan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE 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: R888||Abnormal findings in other body fluids and substances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
OZONIZED WATER |
IRRIGATION WITH OZONIZED WATER
DOSE-2ppm
FREQUENCY-ONCE IN TWO WEEKS(TWICE)
DURING SUPRAGINGIVAL SCALING AND SUBGINGIVAL SCALING- 2 SEPARATE APPOINTMENTS
ROUTE OF ADMINISTRATION-VIA ULTRASONIC SCALER USING OZONE GENERATOR
DURATION- EACH APPOINTMENT WILL TAKE 20 MINUTES APPROXIMATELY |
| Comparator Agent |
STERILE WATER |
IRRIGATION WITH STERILE WATER
DOSE-NOT APPLICABLE
FREQUENCY-ONCE IN TWO WEEKS(TWICE)
DURING SUPRAGINGIVAL SCALING AND SUBGINGIVAL SCALING- 2 SEPARATE APPOINTMENTS
ROUTE OF ADMINISTRATION-VIA ULTRASONIC SCALER FROM STERILE WATERLINE
DURATION- EACH APPOINTMENT WILL TAKE 20 MINUTES APPROXIMATELY |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Generalized Stage III periodontitis ( diagnosed according to 2017 world workshop on the classification of periodontal and peri-implant diseases and conditions)
Patients with minimum of 20 remaining teeth
Subjects with Probing Pocket Depth (PPD) greater than or equal to 5mm.
Subjects with gingival index score greater than or equal to 1.
Subjects who have not received periodontal therapy within the last 6 months.
Those willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases which contraindicate periodontal surgical procedures
Patients who have taken antibiotics or anti-inflammatory drugs for the past 3 months
Pregnant and lactating females.
Immunocompromised patients
Patients who are undergoing orthodontic treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Results of evaluation of clinical parameters |
20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Results of biochemical analysis of saliva and 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) |
20 minutes |
|
|
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 1 |
|
Date of First Enrollment (India)
|
15/07/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ozone has been shown to
possess unique properties and has potential applications to the clinical
practice of dentistry and medicine. Ozone oxidizes biomolecules, disrupts
microbial cell structures and metabolism. Ozone disrupts microbial cell walls in
seconds, leading to immediate cell lysis. An ozone application of 10 – 20 second
has been reported to eliminate more than 99% of the microorganisms found in the
dental caries .Ozone has been applied for treatment of early
carious lesions, sterilization of cavities, root canals, enhancing epithelial wound
healing such as ulcerations and herpetic lesions
Periodontitis
is a chronic multifactorial inflammatory disease of microbial origin. The
beneficial properties of ozone such as antimicrobial (bactericidal, viricidal,
and fungicidal) immunostimulating, immune modulatory and anti-inflammatory
makes it an excellent choice for treatment of periodontitis |