| CTRI Number |
CTRI/2024/02/063033 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two plant based mouthwashes in reducing bacteria in the mouth of the children . |
|
Scientific Title of Study
|
Comparative evaluation of the unripe Aegle marmelos ,Mangifera indica Leaves and their combination, with Kidodent as a mouthwash in reduction of salivary S. mutans count in children –A randomisied controlled clinical study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Revati |
| Designation |
PG student |
| Affiliation |
AMES Dental College and Hospital |
| Address |
AMES Dental College And Hospital,Room no.4 ,Department of Pedodontics and Preventive Dentistry , Near Bijingera Road Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
8904536502 |
| Fax |
|
| Email |
revathi.kandalam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghavendra Havale |
| Designation |
Head of the department |
| Affiliation |
AMES Dental College and Hospital |
| Address |
Room no.4 ,Department of Pedodontics and Preventive Dentistry ,AMES Dental College And Hospital, Near Bijingera Road Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
9448407300 |
| Fax |
|
| Email |
raghavendrahavale@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SHRUTHA SP |
| Designation |
Professor |
| Affiliation |
AMES Dental College and Hospital |
| Address |
Room no.4 ,Department of Pedodontics and Preventive Dentistry ,AMES Dental College And Hospital, Near Bijingera Road Raichur
Raichur
KARNATAKA
584103
India |
| Phone |
8660091861 |
| Fax |
|
| Email |
shruthavinit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Students of Morarji Desai residential school, Bolamanadoddi Road ,Vidya Nagar Raichur -584103 Karnataka |
|
|
Primary Sponsor
|
| Name |
Revati |
| Address |
Room no.4 ,Department of Pedodontics and Preventive Dentistry ,AMES Dental College And Hospital, Near Bijingera Road Raichur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Raghavendra Havale |
Room no.4 ,Department of Pedodontics and Preventive Dentistry ,AMES Dental College And Hospital, Near Bijingera Road Raichur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Revati |
Morarji Desai Residential School |
Main block, Medical room, Morarji Desai Residential School, Bolamanadoddi Road, Vidya Nagar, Raichur
Raichur
KARNATAKA |
8904536502
revathi.kandalam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of AMES dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Unripe Aegle marmelos Mouthwash |
10 ml of Aegle marmelos mouthwash is will be given in the morning daily to the 15 children for 28days. |
| Intervention |
Combination of unripe Aegle marmelos and Mangifera indica leaves mouthwash |
10 ml of combination of unripe Aegle marmelos and Mangifera indica leaves mouthwash will be given in the morning daily to the 15 children for 28days |
| Comparator Agent |
Kidodent mouthwash |
10ml of kidodent mouthwash will be given in the morning daily to the 15 children for 28days |
| Intervention |
Mangifera indica leaves mouthwash |
10 ml of Mangifera indica mouthwash will be given in the morning daily to the 15 children for 28days. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of age between 9-12 years with good general health, devoid of any infectious diseases and willing to co operate for the study will be selected |
|
| ExclusionCriteria |
| Details |
1. Children who cannot expectorate completely
2. Any intraoral pathology
3. Using any oral hygiene aids,
4. Children on antibiotics in the month before and during the research period.
5. With any sort of intraoral prosthesis or undergoing orthodontic treatment
6. The one not available for the follow up phase.
|
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the reduction of S.mutans count in children following the administration of herbal mouthwashes |
Evaluate the S.mutans count on 1st, 7th,14th and 28th day of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate patient acceptance and adverse effects of herbal mouthwashes on oral tissues |
28 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this In-vivo study is Comparative evaluation of antimicrobial efficacy of herbal extracts of unripe Aegle marmelos fruit ,Mangifera indica leaves and their combination with kidodent against caries causing Streptococcus mutans. The study will be undertaken in the residential schools of Raichur district .A total of 60 participants divided into 4 groups with 15 in each group will be selected. Herbal mouthwashes will be prepared from ethanolic extracts of unripe Aegle marmelos fruit ,Mangifera indica leaves . Before initiating the study oral prophylaxis will be performed and saliva samples will be collected from the selected participants to evaluate the base line S mutans count and salivary pH. The prepared herbal mouthwashes will be given to the selected groups daily in the morning for 28 days. S mutans and salivary pH count will be evaluated on 7th, 14th and 28th day. |