| CTRI Number |
CTRI/2019/01/017038 [Registered on: 10/01/2019] Trial Registered Prospectively |
| Last Modified On: |
10/01/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two mouthwashes in microbial count reduction prior to dental cleaning procedure. |
|
Scientific Title of Study
|
Comparison of Efficacy of 0.2%chlorhexidine and herbal mouth wash as a Pre-Procedural Mouth Rinsing in Reducing Aerosol Contamination Produced by Ultrasonic Scaler- microbiology study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 15146 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anushka |
| Designation |
post graduate |
| Affiliation |
SDM Dental College |
| Address |
Dept. of Orthodontics
SDM Dental College, Dharwad,
Karnataka 580009
Dakshina Kannada
KARNATAKA
580009
India |
| Phone |
9880718372 |
| Fax |
|
| Email |
kr_anushka@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sangeeta Nayak |
| Designation |
Associate professor |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Dept. of Periodontology
Manipal College of dental Sciences
Mangalore,
Manipal Academy of Higher Education, Manipal.
Dakshina Kannada
KARNATAKA
576004
India |
| Phone |
9880718372 |
| Fax |
|
| Email |
sangeeta.nayak@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anushka |
| Designation |
Former intern |
| Affiliation |
SDM Dental College |
| Address |
Dept. of Orthodontics
SDM Dental College, Dharwad,
Karnataka 580009
SDM Dental College, Dharwad,
Dakshina Kannada
KARNATAKA
580009
India |
| Phone |
9880718372 |
| Fax |
|
| Email |
kr_anushka@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal. |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences Mangalore |
| Address |
Dept. of Periodontology
Manipal College of dental Sciences
Mangalore,
Manipal Academy of Higher Education, Manipal. |
| Type of Sponsor |
Other [Private Dental 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 Sangeeta Nayak |
Manipal College of dental Sciences |
Dept. of Periodontology
Manipal College of dental Sciences
Mangalore,
Manipal Academy of Higher Education, Manipal.
Dakshina Kannada
KARNATAKA |
9880718372
sangeeta.nayak@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
mild-moderate chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A- chlorhexidine group |
Before the start of ultrasonic scaling saliva sample of the patient will be collected and stored in sterile disposable container. Patients will be asked to rinse with 10ml of 0.2% chlorhexidine mouthwash for 1 minute. After 5 minutes saliva will again be collected from the patient’s mouth and stored in sterile disposable container. The samples will be subjected microbial analysis. Mitis salivarius agar plate will be used to collect the airborne microorganisms as it is valid medium for culturing airborne bacteria. Mitis salivarius agar plates positioned at the patients chest area, at the dentist chest area and at assistant ‘s chest area with the help of double sided adhesive tapes. The average distance will approximately be 12 inches from the patients mouth to agar plate. The agar plates will be incubated at 37.C for 48 hours. |
| Intervention |
group B- Herbal mouthwash |
Before the start of ultrasonic scaling saliva sample of the patient will be collected and stored in sterile disposable container. Patients will be asked to rinse with 10ml of herbal mouthwash for 1 minute. After 5 minutes saliva will again be collected from the patient’s mouth and stored in sterile disposable container. The samples will be subjected microbial analysis. Mitis salivarius agar plate will be used to collect the airborne microorganisms as it is valid medium for culturing airborne bacteria. Mitis salivarius agar plates positioned at the patients chest area, at the dentist chest area and at assistant ‘s chest area with the help of double sided adhesive tapes. The average distance will approximately be 12 inches from the patients mouth to agar plate. The agar plates will be incubated at 37.C for 48 hours. |
| Comparator Agent |
group C- Water |
Before the start of ultrasonic scaling saliva sample of the patient will be collected and stored in sterile disposable container. Patients will be asked to rinse with 10ml of distilled water for 1 minute. After 5 minutes saliva will again be collected from the patient’s mouth and stored in sterile disposable container. The samples will be subjected microbial analysis. Mitis salivarius agar plate will be used to collect the airborne microorganisms as it is valid medium for culturing airborne bacteria. Mitis salivarius agar plates positioned at the patients chest area, at the dentist chest area and at assistant ‘s chest area with the help of double sided adhesive tapes. The average distance will approximately be 12 inches from the patients mouth to agar plate. The agar plates will be incubated at 37.C for 48 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Having a minimum of 20 permanent teeth,
Not having undergone any dental treatment for the past 3 months,
Systemically healthy patients.
Subjects who were diagnosed with mild - moderate form of chronic periodontitis showing more than 30% of sites with clinical attachment loss ≤4mm measured with a Williams periodontal probe. |
|
| ExclusionCriteria |
| Details |
Subjects with any known systemic disease or conditions.
Patients who underwent any periodontal treatment in last 6 months
Patients who are already using mouthwash
Received antibiotics or nonsteroidal anti-inflammatory drugs (NSAIDs) in the past 8 weeks,
Pregnant and lactating mothers,
Smokers.
Patients hypersensitivity to chlorhexidine mouth wash
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bacterial aerosol contamination, Bacterial aerosol count |
Baseline- Before and after the use of mouth wash |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of bacterial aerosol contamination over the operator chest zone, the patient chest zone and the assistant zone. |
Baseline- before and after using the mouthwash |
|
|
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)
|
15/01/2019 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this randomized control trial, the efficacy of reduction in aerosol contamination will be evaluated and compared using 0.12% chlorhexidine mothwash, herbal mouthwash and distilled water. Total of 30 participants will be selected for the study based on inclusion criteria and will be randomized into 3 groups. Prior to the scaling procedure, saliva sample will be collected then pre-procedural mouth rinse will be done. Agar plates will be kept in patient chest zone, assistant zone and operator chest zone during the ultrasonic scaling procedure. Then the agar plates will be sent for microbiological analysis to count the colony forming units. the number of colony forming units among the three groups will be compared. |