| CTRI Number |
CTRI/2022/06/043520 [Registered on: 27/06/2022] Trial Registered Prospectively |
| Last Modified On: |
25/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Compare The Effect Of mouth Rinse & Ultrasonic Coolant agent By Using Chlorhexidine Gluconate And Povidone Iodine in Reducing Aerosol Contamination. A Randomized Clinical Trial
|
|
Scientific Title of Study
|
To Compare The Effectiveness Of Ultrasonic Coolant & Pre-procedural Rinse By Using Chlorhexidine Gluconate And Povidone Iodine in Reducing Aerosol Contamination. A Randomized Clinical Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RINI PRATHIPATY |
| Designation |
Postgraduate student |
| Affiliation |
Sree sai dental college and research institute |
| Address |
Department of Periodontics, room no 8, Sree Sai dental college and research institute, Ichapuram, Srikakulam
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8919689937 |
| Fax |
|
| Email |
rinijyothsnaprathipaty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K ANIL KUMAR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Sree sai dental college and research institute |
| Address |
Department of periodontics, room no 8, Sree Sai dental college and research institute, Ichapuram, Srikakulam
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9989570600 |
| Fax |
|
| Email |
anilkanc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RINI PRATHIPATY |
| Designation |
Postgraduate student |
| Affiliation |
Sree sai dental college and research institute |
| Address |
department of periodontics, room no 8, Sree Sai dental college and research institute, Ichapuram, Srikakulam
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8919689937 |
| Fax |
|
| Email |
rinijyothsnaprathipaty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree sai dental college and research institute, Ichapuram, balaga rural, Srikakulam. 532001 |
|
|
Primary Sponsor
|
| Name |
Dr Rini Prathipaty |
| Address |
Sree Sai dental college and research institute |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RINI |
sree sai dental college |
Department of Periodontics/ room no 8
Srikakulam
ANDHRA PRADESH |
8919689937
rinijyothsnaprathipaty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical 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 |
Preprocedural rinse |
Chlorhexidine Gluconate 0.2% and povidone iodine 2%
rinsing for 60 sec, once before scaling |
| Comparator Agent |
ultrasonic coolant agent |
Chlorhexidine Gluconate 0.2% and povidone iodine 2% with dilution of one part agent and 9 parts water
20 mins of ultrasonic scaling, during scaling |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age range of 20-30years
Minimum of 20 sound natural teeth.
Systemically healthy individuals who are diagnosed with Gingivitis.
Probing pocket depth < 3mm
|
|
| ExclusionCriteria |
| Details |
Thyroid dysfunction.
Smoking in any form
Periodontal treatment in past 6 months
Pregnancy and lactating women.
Immunocompromised patients.
Untreated carious/grossly decayed tooth.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessing the number of colony forming units for different groups |
baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
06/07/2022 |
| 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="4"
Days="1" |
|
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 is a randomized, triple blind, parallel group controlled clinical trial, comparing and evaluating the efficacy of pre-procedural rinse and ultrasonic coolant in reducing aerosol contamination during ultrasonic scaling procedures. The primary outcome measure is counting the colony forming units after 20 mins of ultrasonic scaling using either pre procedural rinse or ultrasonic cooling agent. Blood agar plates will be placed at 3 different locations for settling of aerosols, and the blood agar plates will be incubated in a aerobic chamber for 48 hrs at 37C and colony counting will be done.
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