| CTRI Number |
CTRI/2021/07/034954 [Registered on: 19/07/2021] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative assessment of the anti-cavity effectiveness of Makandi root extract, cranberry extract and magnetized water as mouth washes in 6-12 years old children |
|
Scientific Title of Study
|
Comparative evaluation of the anti-cariogenic efficacy of Coleus forskohlii root extract, Cranberry extract and Magnetized water as mouthrinses in 6-12 years old children – An in vivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mangetri Fasale |
| Designation |
Post Graduate Student |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Department of paediatric and preventive dentistry
Department number 9
Pacific Dental College and Hospital
Airport Road
Debari
Udaipur
RAJASTHAN
313024
India |
| Phone |
9359046242 |
| Fax |
|
| Email |
mangetri.fasale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Professor and Head of the Department |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Department of Paediatric and Preventive Dentistry
Department number 9
Pacific Dental College and Hospital
Airport Road
Debari
Udaipur
RAJASTHAN
313024
India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangetri Fasale |
| Designation |
Post Graduate Student |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Department of paediatric and preventive dentistry
Department number 9
Pacific Dental College and Hospital
Airport Road
Debari
Udaipur
RAJASTHAN
313024
India |
| Phone |
9359046242 |
| Fax |
|
| Email |
mangetri.fasale@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1. Mr. Ashish Aote - Shreedutt Medical, Nagpur
2. Dr. K.C.Gupta - Sai Tirupati university, Udaipur |
|
|
Primary Sponsor
|
| Name |
Self Dr Mangetri Fasale |
| Address |
Pacific Dental College and Hospital
Debari
Udaipur
Rajasthan
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Mangetri Fasale |
Pacific Dental College and Hospital |
Department of Paediatric and Preventive Dentistry
Department number 9
Pacific Dental College and Hospital
Airport road
Debari
Udaipur
RAJASTHAN |
9359046242
mangetri.fasale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pacific Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human volunteers visiting the pediatric dental OPD |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coleus Forskohlii root extract, Cranberry extract, Magnetized water, Chlorhexidine |
To be used as mouthrinses in children aged 6-12 years and the salivary parameters will be recorded. 1 ml mouthrinse will be given orally at intervals of 0 mins, 10 mins and 30 mins. The therapy will be carried out for a period of 60 minutes. |
| Intervention |
Coleus Forskohlii root extract, Cranberry extract, Magnetized water, chlorhexidine mouthrinse |
To be used as mouthrinses in children aged 6-12 years and the salivary parameters will be recorded. 1 ml mouthrinse will be given orally at intervals of 0 mins, 10 mins and 30 mins. The therapy will be carried out for a period of 60 minutes. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy patients
2. No fixed or removable orthodontic appliance or removable prosthesis
3. No history of antibiotics in the previous 1 month
4. No history of use of any mouthwash
5. No history of oral prophylaxis done for at least 3 months prior to the study
6. Mixed dentition period |
|
| ExclusionCriteria |
| Details |
1. Patient with abscess, draining sinus, cellulitis or other conditions requiring emergency medical treatment.
2. Patient with severe malalignment of teeth.
3. Patient with medical or pharmacological history.
4. History of fluoride treatment in past 2 weeks. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Coleus forskohlii root extract, Cranberry extract and magnetized water may show similar efficacy as that of chlorhexidine mouthrinse i.e 68% approximately and can be effectively used as an alternative to it. All three parameters are the primary outcome measures. |
0 minutes, 10 minutes, 30 minutes, 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All three salivary buffering capacity, salivary pH and salivary S. mutans count are primary outcome measures and there will be no secondary outcomes. |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/07/2021 |
| Date of Study Completion (India) |
28/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Mangetri Fasale, Dinesh Rao, Sunil Panwar.
Comparative evaluation of the anti-cariogenic
efficacy of Coleus forskohlii root extract,
cranberry extract and magnetized water as mouthrinses in 6-12 years old children: An in vivo study. Contemp Pediatr Dent 2022:3(3):103-111. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION - Chlorhexidine is still the gold standard mouthrinse for its antimicrobial action and high substantiveness, but side effects, such as pigmentation, taste alteration, and the formation of supragingival calculus limit its continued use. The less availability and unaffordable cost of new generation antibiotics initiated to look for alternative phytomedicine to discover plant derived constituents with claimed antimicrobial activity.
AIM - To evaluate in vivo and to compare the anti-cariogenic efficacy of Coleus forskohlii root extract, Cranberry extract and magnetized water as mouthrinses by analysing pH and buffering capacity of saliva and Streptococcus mutans count in 6-12 years old children
METHODOLOGY - This study is a prospective randomized controlled, parallel group, multiple arm trial consisting of 120 children between the age group of 6-12 years, who are willing to participate in the study. The children will be selected according to the inclusion and exclusion criteria and randomly allocated to the study and control groups. They will be asked to rinse with the mouth rinse for about 60 seconds and unstimulated saliva will be collected pre-rinse as well as 10 minutes, 30 minutes and 60 minutes after rinsing and the pH and buffering capacity of saliva and Streptococcus mutans count of the same will be evaluated.
EXPECTED CONCLUSION - It is expected that Coleus forskohlii root extract, Cranberry extract and magnetized water show similar efficacy as that of chlorhexidine mouthrinse and can be effectively used as an alternative to it.
|