| CTRI Number |
CTRI/2025/04/085485 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of chlorhexidine varnish and riboflavin in reducing oral bacteria in people with braces. |
|
Scientific Title of Study
|
COMPARING THE EFFICACY OF RIBOFLAVIN A PHOTOSENSITISING COMPOUND AND CHLORHEXIDINE VARNISH IN CONTROLLING ORAL MICROFLORA IN ORTHODONTIC PATIENTS
A RANDOMISED CONTROLLED TRIAL
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SobikaS |
| Designation |
post graduate student (MDS) |
| Affiliation |
Sri venkateswara dental college and hospital |
| Address |
Room no 6, department of Orthodontics and Dentofacial Orthopedics, Sri
Venkateswara Dental College and Hospital, off Old Mahabalipuram
Road,thalambur, Chennai, Tamil Nadu 600130
Chennai
TAMIL NADU
600130
India |
| Phone |
9677497399 |
| Fax |
|
| Email |
sobika.sudhakar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sumanth Rangarajan |
| Designation |
Professor |
| Affiliation |
Sri venkateswara dental college and hospital |
| Address |
Room no 6, department of Orthodontics and Dentofacial Orthopedics, Sri
Venkateswara Dental College and Hospital, off Old Mahabalipuram
Road,thalambur, Chennai, Tamil Nadu 600130
Chennai
TAMIL NADU
600130
India |
| Phone |
9952034634 |
| Fax |
|
| Email |
drsumanthranga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sumanth Rangarajan |
| Designation |
Professor |
| Affiliation |
Sri venkateswara dental college and hospital |
| Address |
Room no 6, department of Orthodontics and Dentofacial Orthopedics, Sri
Venkateswara Dental College and Hospital, off Old Mahabalipuram
Road,thalambur, Chennai, Tamil Nadu 600130
Chennai
TAMIL NADU
600130
India |
| Phone |
9952034634 |
| Fax |
|
| Email |
drsumanthranga@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sobika.s |
| Address |
sri venkateswara dental college and hospital,off old mahabalipuram road,thalambur,near navalur,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 |
| SobikaS |
sri venkateswara dental college and hospital |
Room no 6, Department of
Orthodontics and Dentofacial
Orthopedics,Off
old mahabalipuram
road,thalambur, chennai,
tamilnadu 600130
Kancheepuram
TAMIL NADU
Chennai
TAMIL NADU |
09677497399
sobika.sudhakar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri venkateswara dental college and hospital institute ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouthwash |
5 ml of chlorhexidine mouthwash will be given to the patient and asked to rinse for 1 minute |
| Intervention |
Riboflavin (vitamin B2) |
0.5% riboflavin solution is prepared and given to the patient to rinse the mouth for 1 minute and further it is activated using blue LED light |
| Intervention |
Riboflavin with surfactant |
In riboflavin solution,0.01% sodium lauryl sulfate is added to enhance the agent to disrupt the bacteial cell |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Good general health
Absence of systemic antibiotic intake at least 3 months prior to study,
Under fixed orthodontic treatment
Absence of oral lesions
Supragingival calculus
Severe malocclusion
Evident dental plaque accumulation.
|
|
| ExclusionCriteria |
| Details |
The use of mouthwashes during the study and the follow-up,
Pregnancy
Systemic disorders
History of parafunctional and deleterious habits (tobacco chewing)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparing the reduction of bacterial count among the experimental groups.
To find out the number of live and dead bacterias using confocal laser microscopy
|
T0 - Before application of test agents
T1- Immediately after application
T2 - 60 days after application
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the percentage of live and dead bacterias using confocal laser scanning microscopy |
T0,T1 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="0" |
|
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
|
This study is a Randomised, parallel, active controlled trial which compares the efficacy of 0.5% riboflavin in solution form and 0.12% chlorhexidine mouthwash given once a week for consecutively four weeks in 30 orthodontic patients who are undergoing treatment for the past 6 months. The primary outcome of the study will be comparing the reduction of bacterial count at T0 ( before application), T1 (Immediately after application, T2 ( 60 days from initial application). The secondary outcomes will be assessing the viability of bacterias using confocal laser scanning microscopy at T0 and T1. |