| CTRI Number |
CTRI/2022/02/040010 [Registered on: 03/02/2022] Trial Registered Prospectively |
| Last Modified On: |
03/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
comparision of regular used suction tip with newly modified suction tip for control of spread of infective aerosol from ultrasonic scaling |
|
Scientific Title of Study
|
Experimental, analytical, clinico-microbial split mouth study to compare an ingenious and conventional suction tip in reducing aerosol during ultrasonic scaling in biofilm induced gingivitis patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mallinath Govind Jadhav |
| Designation |
PG Student |
| Affiliation |
MGV KBH Dental college Nashik |
| Address |
301, 302, Department of periodontics,
MGV KBH Dental college,Nashik
MGV KBH Dental college,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9890141235 |
| Fax |
|
| Email |
mallijadhav84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapna Mahale |
| Designation |
Professor and Head of department |
| Affiliation |
MGV KBH Dental college Nashik |
| Address |
301 302 Department of periodontics
MGV KBH Dental college, Nashik
MGV KBH Dental college,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422764080 |
| Fax |
|
| Email |
drsamahale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mallinath Govind Jadhav |
| Designation |
PG Student |
| Affiliation |
MGV KBH Dental college Nashik |
| Address |
301 302 Department of periodontics
MGV KBH Dental college,Nashik
MGV KBH Dental college, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9890141235 |
| Fax |
|
| Email |
mallijadhav84@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGV KBH Dental College and Hospital, Nashik |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Mallinath Jadhav |
MGV KBH Dental College, Nashik |
301 302 Department of periodontics
MGV KBH Dental college and hospital, Nashik
Nashik
MAHARASHTRA |
9890141235
mallijadhav84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH Dental college- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional suction tip |
Ultrasonic scaling will be done under conventional suction tip for 10 minutes |
| Intervention |
Ingenious Suction tip |
Ultrasonic scaling will be done under ingenious suction tip for 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Biofilm induced gingivitis
2. Age – 18-60 years.
3. Patients who are voluntarily ready to be a part of study and give informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients with medical conditions contraindicating the use of ultrasonic scalers were excluded from the study.
2.Uncooperative patients.
3.Not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| colony forming unit count test |
after 48 hours colony forming unit will counted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
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)
|
06/02/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/02/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
This study will be carried out in 30 sides
(left/right) in 15 patients (split mouth) in biofilm induced gingivitis patients undergoing
ultrasonic scaling procedure. Patients meeting the inclusion criteria will be
considered for the present study.
Selected patients will be divided into 2
groups:
Group A (test side)- Ultrasonic scaling will
be done (on left or right half of the mouth) with an ultrasonic scaler, along
with ingenious suction tip for 10 mins.
Group B (15 sides): - Ultrasonic scaling will
be done (on left or right half of the mouth) with an ultrasonic scaler with
conventional suction tip for 10 mins.
Procedure
Biofilm induced
gingivitis patients ready for
ultrasonic scaling will be provided information about the study.
Informed verbal and written consent will be
obtained from each subject.
Each study participant will act as his/her own
control and will be subjected to both the study group criteria.
Group A (15 sides): - Ultrasonic scaling will
be done (on left or right half of the mouth) with an ultrasonic scaler, along
with ingenious suction tip for 10 mins.
Patient will be shifted to another operatory
for remaining ultrasonic scaling of other half of the mouth.
|