| CTRI Number |
CTRI/2025/02/081399 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of ozone oil in socket after surgical extractions for pain control and wound healing - A randomized controlled trial |
|
Scientific Title of Study
|
Intra-alveolar use of Ozone oil after Transalveolar Extractions for pain control and wound healing – A Randomized Controlled 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 Richa Mishra |
| Designation |
Post graduate |
| Affiliation |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences
Department five Oral and maxillofacial surgery Nehru Nagar
Belgaum
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8658400971 |
| Fax |
|
| Email |
mrichamishra@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SM Kotrashetti |
| Designation |
Professor |
| Affiliation |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences
Department five Oral and maxillofacial surgery Nehru Nagar
Belgaum
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448116959 |
| Fax |
|
| Email |
kotra27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SM Kotrashetti |
| Designation |
Professor |
| Affiliation |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences |
| Address |
KAHERs KLE Vishwanath Katti Institute of Dental Sciences
Department five Oral and maxillofacial surgery Nehru Nagar
Belgaum
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448116959 |
| Fax |
|
| Email |
kotra27@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Vishwanath Katti Institute of Dental sciences , Nehru Nagar, Belagavi ,590010, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
Dr Richa Mishra |
| Address |
KAHERs KLE VKIDS Nehru Nagar Belgaum , 590010 , Karnataka, India |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Richa Mishra |
KLE Vishwanath Katti Institute of Dental Sciences |
Department no. 5, Oral
and maxillofacial
surgery, Nehru nagar
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
8658400971
mrichamishra@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethics committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.9% Normal saline |
Socket will be irrigated with Normal saline once |
| Intervention |
Ozone Oil |
1ml of Ozone oil soaked in
Absorbable gelatin sponge placed in extraction socket once for pain management and wound healing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients willing to participate in the study.
Any tooth indicated for open extraction or any surgical extraction of impacted tooth.
Patients who have not used any antibiotic antimicrobial, analgesic or anti-inflammatory drugs before the surgery.
Patients who are non- smokers.
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study
Patients with presence of any systemic diseases
Patients with previous history of allergy
Patients with history of oral contraceptives
Pregnant and lactating females
Patients undergoing Orthodontic extractions
Mentally challenged patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of ozone oil on postoperative pain
To evaluate and compare the postoperative frequency of analgesic usage. |
Postoperative pain will be checked by Visual analogue Scale at following
intervals postoperatively:
4 hours
8 hours
12 hours
24 hours
3rd day
7 day
POSTOPERATIVE ANALGESIC DOSAGE
The number of analgesic doses (if taken any) also recorded on 7th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of ozone oil on postoperative swelling, trismus, & wound healing. |
Swelling ,Trismus & wound healing will be checked on 3rd & 7th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/03/2025 |
| 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="0"
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
|
This study aims to evaluate the efficacy of ozone oil when placed in the extraction socket after a transalveolar extraction.The objectives are to evaluate the effect of ozone oil on postoperative pain , swelling, trismus, wound healing and compare the postoperative frequency of analgesic usage.
|