| CTRI Number |
CTRI/2024/01/061671 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [local application of Ozone oil] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess if the topical application of Ozone oil at dental extraction wound can reduce post extraction pain, improve wound healing and reduce consumption of post extraction analgesics. |
|
Scientific Title of Study
|
Therapeutic effect of topical application of ozone oil in non-surgical extraction- A double blind 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 |
Anunay Pangarikar |
| Designation |
Associate Professor |
| Affiliation |
ESIC Dental College Kalaburagi |
| Address |
Department of Oral and Maxillofacial Surgery
ESIC Dental College
Sedam Road
Gulbarga
Gulbarga
KARNATAKA
585106
India |
| Phone |
7845814696 |
| Fax |
|
| Email |
dr.pangarikarab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anunay Pangarikar |
| Designation |
Associate Professor |
| Affiliation |
ESIC Dental College Kalaburagi |
| Address |
Department of Oral and Maxillofacial Surgery
ESIC Dental College
Sedam Road
Gulbarga
Gulbarga
KARNATAKA
585106
India |
| Phone |
7845814696 |
| Fax |
|
| Email |
dr.pangarikarab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anunay Pangarikar |
| Designation |
Associate Professor |
| Affiliation |
ESIC Dental College Kalaburagi |
| Address |
Department of Oral and Maxillofacial Surgery
ESIC Dental College
Sedam Road
Gulbarga
Gulbarga
KARNATAKA
585106
India |
| Phone |
7845814696 |
| Fax |
|
| Email |
dr.pangarikarab@gmail.com |
|
|
Source of Monetary or Material Support
|
| ADC Inclusive Dent-Ozone, India. |
|
|
Primary Sponsor
|
| Name |
ESIC Dental College |
| Address |
Sedam Road, Gulbarga, Karnataka |
| Type of Sponsor |
Government medical college |
|
|
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 Anunay Pangarikar |
ESIC Dental College |
Room N0. 6, second floor, Department of Oral and Maxillofacial Surgery, ESIC Dental College, Sedam Road, Gulbarga, Karnataka.
Gulbarga
KARNATAKA |
7845814696
dr.pangarikarab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of ESIC Dental College Gulbarga |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
indicated for tooth extraction |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local application of Glycerin at tooth extraction site as a placebo. |
Normal tooth extraction, Glycerin is locally applied at extraction site for 5 min and then mouth is rinsed. then patient to apply glycerin 3 times a day locally at extraction site for 3 days. |
| Intervention |
Local Application of Ozone oil ( ADC INCLUSIVE DENT OZONE INDIA, OZONOINDS) at tooth extraction site. |
Normal tooth extraction, ozone oil is locally applied at extraction site for 5 min and then mouth is rinsed. then patient to apply ozone oil 3 times a day locally at extraction site for 3 days. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individual who have no systemic diseases and indicated for simple dental extraction.
|
|
| ExclusionCriteria |
| Details |
patient below 18 years.
pregnant or lactating women.
patient with systemic diseases.
patient currently on any medications. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) reduction in post extraction pain.
2) reduction in consumption of post analgesics post operatively.
|
1) Till 7th post operative day.
2) Till 7th post operative day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| better healing of extraction socket. |
Till 7th post operative day. |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
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 - NO
|
|
Brief Summary
|
This is interventional double blinded parallel group with placebo control clinical trial where therapeutic effect of local application of ozone oil at dental extraction socket is assessed. Local application of ozone oil at wound have proved to be beneficial in many previous studies. Hence we decided to assess its therapeutic effect on Dental extraction. institutional ethical committee clearance is obtained. The aim of this study is to assess if local application of Ozone oil provides better healing, less post operative pain and less consumptions of post operative analgesics. All cases will be recruited in this study as per inclusion and exclusion criteria. Procedure will be explained completely to every patient and all the doubts of patients will be answered in their own language. If patient ready to give his/her consent for study then only will be recruited for study after signing of written informed consent. patients and observers are blinded. All the patients will be reviewed on 2nd and 7th day for pain and healing of wound. also will be asked for amount of analgesics consumed till 7th day post extraction. All the data will be collected and will be processed by statistician for final result. if proven to be effective, it can reduce consumption of post operative medications, hence less systemic load. As it is applied locally, no known side effect is mentioned in literature. |