| CTRI Number |
CTRI/2017/12/010895 [Registered on: 15/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparing the efficiency of various mouthrinses on streptococcus mutans count in children having caries |
|
Scientific Title of Study
|
To compare the effectiveness of different mouthrinses on Streptococcus mutans count in caries active children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIl |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aakansha Sharma |
| Designation |
Post graduate student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar. UP, ROOM NO. 5, DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar. UP
ROOM NO. 5, DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY
Ghaziabad
UTTAR PRADESH
250002
India |
| Phone |
09761492439 |
| Fax |
01232224958 |
| Email |
aakansha09s.as@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Agarwal Guide |
| Designation |
Head of Department |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar. UP
Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar. UP
Ghaziabad
UTTAR PRADESH
250002
India |
| Phone |
09871262302 |
| Fax |
01232224958 |
| Email |
doc.nagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aakansha Sharma |
| Designation |
Post graduate student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar. UP
Room no. 5, Department of Pedodontics and Preventive Dentistry
Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar. UP
Room no. 5, Department of Pedodontics and Preventive Dentistry
Ghaziabad
UTTAR PRADESH
250002
India |
| Phone |
09761492439 |
| Fax |
01232224958 |
| Email |
aakansha09s.as@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies |
| Address |
Institute of Dental studies and Technologies,NH-58 Kadrabad, Modinagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Aakansha Sharma |
Institute of Dental Studies and Technologies |
Room No. 5 Department of Pedodontics and Preventive Dentistry
Ghaziabad
UTTAR PRADESH |
09761492439
aakansha09s.as@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 |
caries active children, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INTERVENTION 1- Chlorhexidine mouthrinse (Hexidine) |
Chlorhexidine gluconate (CHX) is a cationic bisbiguanide a broad- spectrum antibacterial agent that acts against gram-positive and gram-negative bacteria as well as yeasts, spores, lipophilic viruses, and dermatophytes |
| Intervention |
Intervention 2-Herbal mouthrinse (Hiora) |
The ingredients of this mouthwash are-
1. Pilu (Salvadora persica)
2. Nagavalli (Piper betel)
3. Bibhitaki (Terminalia bellerica)
4. Gandhapura taila (Gaultheria fragrantissima)
5. Ela (Elettaria cardomum)
6. Peppermint satva (Mentha Piperita)
7. Yavanisatva (Tachyspermum ammi)
|
| Intervention |
Intervention 3- sodium fluoride mouthwash (Fluoritop) |
Sodium fluoride is a chemical agent that is made up of cationic sodium and anionic fluoride molecules.Fluoride displays its bacteriostatic properties by many pathways. It blocks an enzyme of the glycolytic pathway, enolase. Subsequently, inhibition of carbohydrate uptake by oral microbes via PEP (phosphoenolpyruvate) dependent phosphotransferase system (PEP-PTS) occurs. |
| Intervention |
Intervention 4- Water |
water acted as the control group |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children between ages of 6-12 years.
2. Patient having one or more than one interproximal carious lesions, well into the dentin, visualized radiographically.
3. All teeth and surrounding tissues were clinically and radiographically free of any other pathologic condition
|
|
| ExclusionCriteria |
| Details |
1. Physical limitations, which might preclude the normal tooth brushing and mouth rinsing.
2. Presence of any intraoral infections.
3. Medically compromised patients or those who were on any long term medication.
4. Subjects with history of taking antibiotics 1 month prior to or during the course of study.
5. Patient reporting with pain or history of pain requiring immediate treatment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in streptococcus mutans level |
Baseline and 15 days |
|
|
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)
|
11/02/2016 |
| Date of Study Completion (India) |
11/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No prior publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study was conducted in Institute of Dental studies and Technologies in department of Pedodontics and Preventive dentistry. The antimicrobial activity. of Chlorhexidine, Sodium fluoride and Herbal mouth rinse were evaluated for their efficacy against S. mutans in 60 children aged 6-12 years old. Plain water acted as the control group. Aakansha Sharma acted as the primary investigator and Dr. Nidhi Agarwal, Dr. Zohra Jabin, Dr. Ashish Anand were the other co investigators of the study.The values obtained were subjected to statistical analysis. ANOVA test, student-t test and paired t-test were used for evaluation. The ean DMFT/deft of the caries active children was 5.93. There was a statistically significant reduction of S. mutans seen in chlorhexidine and Fluoride mouthrinse group in the pre and post rinse values with a p value of 0.003 and0.028 respectively. The
mean Streptococcus mutans count in pre- rinse groups were as follows: In group
I the mean S. mutans count was 1.259 * 105+ 1.174, in Group
II was 0.649* 105 + 0.987, in Group III was 1.624* 105 +
2.276 while in Group IV it was 0.795* 105 + 1.427. The mean Streptococcus mutans count in post- rinse groups
were as follows:
In group I the mean S. mutans count was 0.214* 105+0.130,
in Group II was 0.297* 105 + 0.446, in Group III was 0.238*
105+ 0.217 while in Group IV it was 0.786* 105+
1.405.
There was a reduction in S. mutans seen in hiora mouthrinse group however it was not statistically significant with a p- value of 0.057 . Water showed no reduction and a p- value of 0.184 was obtained for it when the pre and post rinse counts were compared. All the mouthrinses used in the present study have shown a definite decline in S. mutans count. |