| CTRI Number |
CTRI/2024/06/068548 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Ozonated oil in reducing the severity of chronic periodontitis after scaling and root planing as an alternative to chlorhexidine |
|
Scientific Title of Study
|
Effectiveness of ozonated oil versus chlorhexidine gel in patients with chronic periodontitis- A randomized control 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 |
Avishek Singh |
| Designation |
Post graduate Student |
| Affiliation |
NIMS Dental College and Hospital, Jaipur |
| Address |
Deparment of Public Health Dentistry, Room no. 8, NIMS Dental College and Hospital, Jaipur
Jaipur
RAJASTHAN
303121
India |
| Phone |
9622338053 |
| Fax |
|
| Email |
avisheksingh80a@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Naganandini S. |
| Designation |
Head of the deaprtment |
| Affiliation |
NIMS Dental College and Hospital, Jaipur |
| Address |
Department of Public Health dentistry, Room no. 8, NIMS Dental College and Hospital, Jaipur
RAJASTHAN
303121
India |
| Phone |
9622338053 |
| Fax |
|
| Email |
naganandini36@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avishek Singh |
| Designation |
Post graduate Student |
| Affiliation |
NIMS Dental College and Hospital, Jaipur |
| Address |
Department of Public Health Dentistry, Room no. 8, NIMS Dental College and Hospital, Jaipur
RAJASTHAN
303121
India |
| Phone |
9622338053 |
| Fax |
|
| Email |
avisheksingh80a@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ozone Forum of India
3rd floor, Bisleri tower off western express highway, Andheri- Kurla road, Mumbai, Maharashtra, India, 400099 |
|
|
Primary Sponsor
|
| Name |
Avishek Singh |
| Address |
Chak Singha, Aghore, 181122, Jammu, Jammu and Kashmir |
| Type of Sponsor |
Other [Dental surgeon] |
|
|
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 |
| Avishek Singh |
NIMS Dental College and Hospital |
Department of Public health dentistry, room no. 8
Jaipur
RAJASTHAN |
9622338053
avisheksingh80a@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS University Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: A498||Other bacterial infections of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine gel |
Chlorhexidine gel to be used topically for oral application for 30 days, once in a day |
| Intervention |
Ozonated oil |
Ozonated oil To be used topically for oral application for 30 days, once in a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from chronic periodontitis with a minimum of at least 10 teeth present in each arch.
2. Bleeding on probing
3. Pocket depth of at least 3 mm
4. Loss of attachment more than 2 mm
|
|
| ExclusionCriteria |
| Details |
1. Patient with history of any systemic disease such as diabetes, hypertension, anaemia and systemic disease related to periodontitis.
2. Patients with fixed prosthesis, removable prosthesis or any orthodontic appliance.
3. Pregnancy or breastfeeding.
4. Use of systemic drugs in last 3 months.
5. Patients who have undergone scaling and root planing in the last 6 month
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effectiveness of ozonated oil over chlorhexidine gel in the treatment of chronic periodontitis |
Baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of plaque score after scaling and root planing and topical application of ozone oil |
Baseline, 1 month and 3 months |
| Reduction of gingival score after scaling and root planing and topical application of ozone oil |
Baseline, 1 month and 3 months |
| Reduction of periodontal probing depth after scaling and root planing and topical application of ozone oil |
Baseline, 1 month and 3 months |
| Reduction of clinical attachment level after scaling and root planing and topical application of ozone oil |
Baseline, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| Date of Study Completion (India) |
24/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/09/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [avisheksingh80a@gmail.com].
- For how long will this data be available start date provided 24-09-2024 and end date provided 09-09-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Chronic
periodontitis a common oral disease among the adult population, characterized
as an inflammatory condition affecting the tissues that support teeth, brought
on by certain microorganisms. It can induce gingival recession, periodontal
pocket formation, or progressive deterioration of the alveolar bone and
periodontal ligament. The deposition of plaque on teeth
and the gingival sulcus is thought to be the main cause of the genesis of
chronic periodontitis and gingivitis.of the best non-surgical
treatments available is scaling and root planning (SRP), which lowers the
bacterial load in addition to reducing dental calculus and plaque. Antimicrobial
treatments must be used in addition to mechanical debridement in places that
are difficult to access, such as deep pockets and furcation areas. A popular
and efficient antibacterial agent used as a supplement after scaling and root
planing (SRP) is chlorhexidine (CHX). .
It should be mentioned moreover, that CHX shows greater cytotoxic effects and other adverse effects like staining and altered taste sensation. In
the recent past, a significant surge in research interest in natural medicine
has been seen.. Of particular note, plant products have become widely used in
the field of microbiology. Although there are many novel therapeutic strategies
which involves using medicinal plants and their products, the application of
the same is appealing and is being studied more and more. Recently, there has
been a resurgence of interest in oils, and their possible antibacterial
properties are beginning to be acknowledged. Adding ozone to these substances may further increase anti bacterial efficacy. In addition to comparing the
outcomes with regular SRP with traditional chlorhexidine gel, this study is being done with the primary aim to evaluate the effectiveness of topical ozone
oil application.
Methodology: Population: Patients with chronic periodontitis Intervention: Scaling + Ozonated oil Comparator: Scaling + Chlorhexidine gel Outcome: Reduction in the degree of chronic peridontitis Study design: Randomized controlled trial Sample size: 56 patients Groups: Two ( Group 1 and Group 2) Study tool: A detailed
case history will be recorded in a specially designed perfoma which include patient’s demographic details, contact information, past medical and dental
history, deleterious habits (if any), oral hygiene habits i.e. brushing method,
technique and dentrifice used, extra oral and intra oral examination. Following
clinical indices were measured at baseline and folllowup-: Plaque index measured using Turesky-
Gilmore -Glickman modification of the
Quigley-Hein Plaque index(1970), GI measured using Loe H and Sillness
J Gingival index (1963), Periodontal probing depth measured
using Periodontal probe (distance measured from the gingival margin to the pocket base) and Clinical attachment level (measured
from CEJ to base of pocket). Consent form duly signed by the
patient after explanation of the study purpose and methodology before the
commencement of the study will be obtained. Two treatment arms of the study will be-: •
For
group 1 Complete Oral Prophylaxis will be done and patients will be advised to apply
Ozone oil daily for a period of one month.
•
For
group 2 Complete Oral Prophylaxis will be done and patients will be advised to
apply chlorhexidine gel daily for a period of one month. Recall
and Clinical evaluation- Follow up will be done at a period of 1 month i.e. 30 days from the start of the treatment
and 3 months i.e. 90 days from the start
of the study to check the following
parameters- Modified PI, GI by loe and sillness, periodontal PPD and loss of
attachment measured by CAL).
Outcome will be measured in terms of reduction of the scores of these indices so as to assess the effectiveness of the intervention group in the disease condition as well as to compare it with the comparator group
|