| CTRI Number |
CTRI/2019/09/021189 [Registered on: 11/09/2019] Trial Registered Prospectively |
| Last Modified On: |
06/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of effectiveness of ozone oil dressing and zinc oxide eugenol dressing in treatment of dry socket. |
|
Scientific Title of Study
|
Effectiveness of ozonated oil dressing versus zinc oxide eugenol dressing in management of alveolar osteitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Joshi |
| Designation |
Head of the Department and professor |
| Affiliation |
Terna Dental college and hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Terna dental college and hospital, plot no.12, sector 22, opposite Nerul west railway station, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9869057337 |
| Fax |
|
| Email |
sanjoshi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Joshi |
| Designation |
Head of the Department and professor |
| Affiliation |
Terna Dental college and hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Terna dental college and hospital, plot no.12, sector 22, opposite Nerul west railway station, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9869057337 |
| Fax |
|
| Email |
sanjoshi99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samruddhi Borate |
| Designation |
PG Student |
| Affiliation |
Terna Dental college and hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Terna dental college and hospital, plot no.12, sector 22, opposite Nerul west railway station, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9619372851 |
| Fax |
|
| Email |
borate.samruddhi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Samruddhi Borate |
| Address |
Departement of Oral and Maxillofacial Surgery, Terna dental college and hospital ,plot no.12 , sector 22 , opposite Nerul west railway station ,Navi Mumbai , Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
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 Samruddhi Borate |
Terna Dental college and Hospital |
Departement of Oral and Maxillofacial Surgery, Terna dental college and hospital ,plot no.12 , sector 22 , opposite Nerul west railway station ,Navi Mumbai
Thane
MAHARASHTRA |
9619372851
borate.samruddhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy patients with alveolar osteitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ozonated oil dressing |
Gauze dipped in ozonated oil will be placed in the dry socket on the day of diagnosis and on 3rd 5th and 7th follow up days |
| Comparator Agent |
Zinc oxide eugenol dressing |
Zinc oxide eugenol dressing will be placed in the dry socket on the day of diagnosis and on 3rd 5th and 7th follow up days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to participate in the study
2.Patients diagnosed with dry socket
3.Patients in the age group between 18 and 70 years |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to be a part of the study
2.Pregnant patients
3.Immunocompromised patients
4.Irradiated patients
5.Patients on steroids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intensity of pain |
3rd, 5th and 7th Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Degree of inflammation
2.Healing |
3rd, 5th and 7th Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/09/2019 |
| 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="8"
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
|
The aim of the study is to evaluate and compare the effectiveness of Ozonated Oil dressing and Zinc Oxide Eugenol dressing in management of alveolar osteitis. Patients will be randomly divided equally into two groups that is group A that is ozonated oil dressing group and group B that is zinc oxide eugenol dressing group. Pre interventional pain score will be recorded using visual analogue scale recorded on Day 0 (day of diagnosis) as baseline reading. Degree of inflammation around the socket walls will be scored using Loe and Silness index. Number of socket walls visible (healing) will be recorded by visual examination. Patient will be recalled on days 3, 5 and 7 for follow up when the dressing will be changed and parameters will be measured again. |