| CTRI Number |
CTRI/2019/09/021425 [Registered on: 26/09/2019] Trial Registered Prospectively |
| Last Modified On: |
03/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Herbal leaves on oral microorganisms |
|
Scientific Title of Study
|
Effect of chewing household herbal leaves
on streptococcus mutans: A randomized
controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja Shetty |
| Designation |
Reader |
| Affiliation |
A.J. Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
A.J. Institute of Dental Sciences,
Kuntikhana,
NH66,
Mangalore
A.J. Institute of Dental Sciences,
Kuntikhana,
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9945859024 |
| Fax |
|
| Email |
shettypoojaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aishwarya Shastry |
| Designation |
Intern |
| Affiliation |
A.J. Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
A.J. Institute of Dental Sciences,
Kuntikhana,
A.J. Institute of Dental Sciences,
Kuntikhana,
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9008941377 |
| Fax |
|
| Email |
aishwaryashastry96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Shastry |
| Designation |
Intern |
| Affiliation |
A.J. Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry,
A.J. Institute of Dental Sciences,
Kuntikhana,
A.J. Institute of Dental Sciences,Kuntikhana
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9008941377 |
| Fax |
|
| Email |
aishwaryashastry96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Dental Association -Dakshina Kannada Branch
Mangalore |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Shetty |
| Address |
Department of Public Health Dentistry
A.J. Institute of Dental Sciences
Mangalore |
| Type of Sponsor |
Other [Primary Investigator] |
|
|
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 |
| Pooja Shetty |
A.J. Institute of Dental Sciences, Mangalore |
Room no 9, Third Floor, Department of Public Health Dentistry, A.J. Institute of Dental Sciences, Mangalore
Dakshina Kannada
KARNATAKA |
9945859024
shettypoojaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| A.J. Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
One cavitated decayed tooth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curry Leaves |
Baseline saliva will be collected. Participant in Curry leaves group will be asked to chew five to six fresh Curry leaves with 5 ml of water in the mouth, rinse for 2 min, and expectorate. Collection of saliva sample will be taken after one week |
| Comparator Agent |
Distilled water |
Baseline saliva will be collected. Participant in Distilled water group will be asked rinse with 5 ml of water in the mouth, rinse for 2 min, and expectorate. Collection of saliva sample will be taken after one week |
| Intervention |
Mint Leaves |
Baseline saliva will be collected. Participant in Mint group will be asked to chew five to six fresh Mint leaves with 5 ml of water in the mouth, rinse for 2 min, and expectorate. Collection of saliva sample will be taken after one week |
| Intervention |
Tulsi Leaves |
Baseline saliva will be collected. Participant in Tulsi group will be asked to chew five to six fresh Tulsi
leaves with 5 ml of water in the mouth, rinse for 2 min, and expectorate. Collection of saliva sample will be taken after one week |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Interns of A.J. Institute of Dental Sciences, Mangalore willing to be a part
of this study, providing informed consent and with at least one cavitated dental caries limited
to dentin will be included |
|
| ExclusionCriteria |
| Details |
Individuals having history of systemic diseases, on antibiotic therapy,
undergoing dental treatment, who were already using any mouth rinses were excluded from the
study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Streptococcusmutans count in saliva after one week of intervention |
After one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/10/2019 |
| Date of Study Completion (India) |
21/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Publication will be done once the study is completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study was conducted among Interns of the Dental Institute to evaluate the effectiveness of chewing household herbal leaves in reducing Streptococcus mutans count. Baseline Saliva was collected. The participants were alloted to Tulsi or Mint or Curry leaves groups or to the distilled water group which served as control. 15 participants were there in each group. They were asked to chew the leaves (Tulsi or Mint or Curry leaves) depending on the group they were alloted to and made to rinse with 5 ml distilled water and spit out. The distilled water group swished with 5 ml water and expectorated. The intervention continued for one week. After a week saliva was collected again. The baseline and after intervention saliva was estimated for Streptococcus mutans count. Statistical analysis was done. It was found that there was a reduction in Streptococcus mutans count on chewing the household herbal leaves, though a significant reduction was found on chewing Tulsi leaves compared to the other groups. |