CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2023/09/058056 [Registered on: 26/09/2023] Trial Registered Prospectively

Last Modified On:

05/04/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Preventive
Dentistry

Study Design

Randomized, Parallel Group, Multiple Arm Trial

Public Title of Study

Comparing the efficiency of various mouthwashes during Fixed Orthodontic Treatment

Scientific Title of Study

Comparitive evaluation of the effect of various mouthwashes in reducing the colony count of Streptococcus Mutans during Fixed Orthodontic Treatment : An IN- VIVO 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	Dr R K Nizaro siyo
Designation	Guide
Affiliation	MALABAR DENTAL COLLEGE AND RESEARCH CENTRE
Address	HEAD OF DEPARTMENT DEPARTMENT OF ORTHODONTICS MALABAR DENTAL COLLEGE AND RESEARCH CENTRE MANNOOR, EDAPPAL , KERALA Thrissur KERALA 679578 India
Phone	9633877412
Fax
Email	ortho@macity.edu.in

Details of Contact Person
Scientific Query

Name	Dr R K Nizaro siyo
Designation	GUIDE
Affiliation	MALABAR DENTAL COLLEGE AND RESEARCH CENTRE
Address	HEAD OF DEPARTMENT DEPARTMENT OF ORTHODONTICS MALABAR DENTAL COLLEGE AND RESEARCH CENTRE MANNOOR, EDAPPAL , KERALA Thrissur KERALA 679578 India
Phone	9633877412
Fax
Email	ortho@macity.edu.in

Details of Contact Person
Public Query

Name	EDWIN CS
Designation	POSTGRADUATE RESIDENT
Affiliation	MALABAR DENTAL COLLEGE AND RESEARCH CENTRE
Address	POST GRADUATE DEPARTMENT OF ORTHODONTICS MALABAR DENTAL COLLEGE AND RESEARCH CENTRE MANNOOR, EDAPPAL , KERALA Thrissur KERALA 679578 India
Phone	9633877412
Fax
Email	dredwincs@gmail.com

Source of Monetary or Material Support

MALABAR DENTAL COLLEGE AND RESEARCH CENTRE

Primary Sponsor

Name	MALABAR DENTAL COLLEGE AND RESEARCH CENTRE
Address	MANOOR- CHEKANOOR ROAD ,MUDUR PO EDAPPAL MALAPPURAM 679578
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR EDWIN CS	MALABAR DENTAL COLLEGE AND RESEARCH CENTRE	GROUND FLOOR DEPARTMENT OF ORTHODONTICS MALABAR DENTAL COLLEGE AND RESEARCH CENTRE MANOOR-CHEKANOOR ROAD , MUDUR PO , EDAPPAL , MALAPPURAM 679578 Thrissur KERALA	9633877412 dredwincs@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
MALABAR DENTAL COLLEGE AND RESEARCH CENTRE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K002\|\|Abnormalities of size and form ofteeth,

Intervention / Comparator Agent

Type	Name	Details
Intervention	coconut oil pulling based mouthwash	prescribed for two times daily after brushing for 60 days
Comparator Agent	curcumin based mouthwash	prescribed for two times daily after brushing for 60 days
Comparator Agent	fluoride based mouthwash	prescribed for two times daily after brushing for 60 days

Inclusion Criteria

Age From	16.00 Year(s)
Age To	25.00 Year(s)
Gender	Both
Details	PATIENTS UNDER THE AGE GROUP 16- 25 WHO ARE UNDERGOING ORTHODONTIC TREATMENT IN THE DEPARTMENT

ExclusionCriteria

Details

1.Patient allergic to Curcumin, Coconut oil, & fluoride
2. Medically compromised Patients
3. Pregnant & Lactating mothers
4. Patients with mouth breathing habit
5. Composite restoration and prosthetic crown on anterior teeth
6. Tooth with developmental anomalies and fluorosis
7. Patients with a habit of smoking
8. Patients taking topical or systemic administration or usage of antibiotic

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
The mouthwash which has better efficiency in reducing streptococcal mutans colony count will be determined.	8 weeks

Secondary Outcome

Outcome	TimePoints
MOUTHWASH WHICH HAS BETTER EFFICIENCY IN PLAQUE CONTROL DURING FIXED ORTHODONTIC TREATMENT	12 weeks

Target Sample Size

Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "55"
Final Enrollment numbers achieved (India)="55"

Phase of Trial

N/A

Date of First Enrollment (India)

26/09/2023

Date of Study Completion (India)

20/03/2024

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 Yet Recruiting

Recruitment Status of Trial (India)

Completed

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
Modification(s)

Oral hygiene is of prime importance in Orthodontic practice. A better understanding of microbiology and infectious diseases is of prime importance for safe clinical practice. Streptococcus mutans are the principle causative organism for Dental caries[1] . Fixed Orthodontic appliances causes areas for bacterial colonization which increases the quantity of Streptococcus mutans and other caries-causing microorganisms[2][3] Brushing is a commonly used method for maintaining Oral hygiene and thereby aids in the reduction of pathogenic organisms. Over the years, various other measures have also been practiced to reduce this bacterial colonization which include fluoridated Dentrifices, mouthwashes, frequent scaling, etc. Among these use of mouthwash is one of the most commonly used. This study aims to evaluate the effect of Curcumin, Pulling oil & Fluoride based mouthwashes in reducing the colony count of Streptococcus mutans.