| CTRI Number |
CTRI/2019/11/021905 [Registered on: 06/11/2019] Trial Registered Prospectively |
| Last Modified On: |
04/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of the effects of two herbal mouthwashes and chlorhexidine mouthwash on the growth of a particular bacteria in patients with dental braces. |
|
Scientific Title of Study
|
comparative evaluation of the effects of curcumin mouthwash, curcumin -rosemary mouthwash and chlorhexidine mouthwash on streptococcus mutans growth in patients undergoing orthodontic treatment. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUJITHA S |
| Designation |
POST GRADUATE |
| Affiliation |
SRM University |
| Address |
SRM DENTAL COLLEGE
2nd floor, department of orthodontics
BARATHI SALAI
RAMAPURAM
CHENNAI
SRM DENTAL COLLEGE
2nd floor, department of orthodontics
BARATHI SALAI
RAMAPURAM
CHENNAI
Thiruvallur
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
sujithasridharan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Poornima R |
| Designation |
Reader |
| Affiliation |
SRM University |
| Address |
SRM DENTAL COLLEGE
2nd floor, department of orthodontics
BARATHI SALAI
RAMAPURAM
CHENNAI
SRM DENTAL COLLEGE
2nd floor, department of orthodontics
BARATHI SALAI
RAMAPURAM
CHENNAI
Thiruvallur
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
Poorni01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUJITHA S |
| Designation |
POST GRADUATE |
| Affiliation |
SRM University |
| Address |
SRM DENTAL COLLEGE
2nd floor, department of orthodontics
BARATHI SALAI
RAMAPURAM
CHENNAI
SRM DENTAL COLLEGE
2nd floor, department of orthodontics
BARATHI SALAI
RAMAPURAM
CHENNAI
Thiruvallur
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
sujithasridharan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sujitha |
| Address |
SRM dental college
ramapuram
chennai
|
| 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 |
| sujitha S |
SRM dental college |
SRM DENTAL COLLEGE
2nd floor, department of orthodontics
BARATHI SALAI
RAMAPURAM
CHENNAI
Ramapuram
Chennai 600089
Thiruvallur
TAMIL NADU |
8939746154
sujithasridharan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients requiring fixed orthodontic treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash, curcumin mouthwash, curcumin rosemary mouthwash |
effects of the mouthwashes against S.mutans bacteria in orthodontic patients.
prescribed amount of the given mouthwash is used twice a day for a period of one month. |
| Intervention |
mouthwashes |
change in the number of S.mutans colonies after the use of the three mouthwashes.
Prescribed amount of the mouthwash to be used twice a day for a period of one month. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. patients who has come for orthodontic treatment.
2. patients with permanent dentition |
|
| ExclusionCriteria |
| Details |
1. patients with active carious lesions and periodontal disease.
2. patients with mouth breathing and thumb sucking habit.
3. patients with smoking habit
4. patients on antibiotic therapy or probiotics
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| there is no significant difference in the effects of the three mouthwashes against the growth of S.mutans bacteria in orthodontic patients |
pre-treatment, 1 month after bonding orthodontic bracket, 1 month after the use of mouthwash |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is a significant difference in the effects of the three mouthwashes against the growth of S.mutans bacteria in orthodontic patients |
pre-treatment, 1 month after bonding orthodontic bracket, 1 month after the use of mouthwash |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 4 |
|
Date of First Enrollment (India)
|
15/11/2019 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| Curcumin mouthwash is reported to be effective against harmful microorganisms as in chlorhexidine mouthwash. However, its effect against streptococcus mutans colony which is implicated to cause dental caries in humans and reported to be increased in patients undergoing orthodontic treatment has not been reported yet. Similarly, Rosemary has been tested and found to be effective against microbial biofilms. However, their effect in conjunction with curcumin has not been reported. Thus, by testing the effectiveness of curcumin mouthwash, curcumin-rosemary mouthwash and chlorhexidine mouthwash it could be established that curcumin mouthwash or curcumin- rosemary mouthwash could be used as a safe and economical alternative to chlorhexidine mouthwash. | |