| CTRI Number |
CTRI/2019/05/018896 [Registered on: 02/05/2019] Trial Registered Prospectively |
| Last Modified On: |
03/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Does application of chitosan varnish reduce food debris accumulation around orthodontic braces? |
|
Scientific Title of Study
|
To compare the biofilm formation following the application of Chitosan varnish or Chlorhexidine varnish in patients undergoing fixed orthodontic treatment: A double blinded randomised controlled trial |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ES Preethi Poornima |
| Designation |
Sr. Lecturer |
| Affiliation |
Dept of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College |
| Address |
Dept of Conservative Dentistry and Endodontics
Meenakshi Ammal Dental College
Alapakkam Main road
Maduravoyal
Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9840111369 |
| Fax |
|
| Email |
preethipoornima08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jogikalmat Krithikadatta |
| Designation |
Reader |
| Affiliation |
Dept of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College |
| Address |
Dept of Conservative Dentistry and Endodontics
Meenakshi Ammal Dental College
Alapakkam Main road
Maduravoyal
Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9840111369 |
| Fax |
|
| Email |
drkrithikadatta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jogikalmat Krithikadatta |
| Designation |
Reader |
| Affiliation |
Dept of Conservative Dentistry and Endodontics, Meenakshi Ammal Dental College |
| Address |
Dept of Conservative Dentistry and Endodontics
Meenakshi Ammal Dental College
Alapakkam Main road
Maduravoyal
Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9840111369 |
| Fax |
|
| Email |
drkrithikadatta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Self-funded, The expenses are borne by the investigators of the study.
Room No 9
Department of conservative dentistry
Meenakshi Ammal dental college
allapakam main road
maduravoyal
chennai
600095
|
|
|
Primary Sponsor
|
| Name |
Meenakshi Ammal Dental College |
| Address |
Alapakkam main road,
maduravoyal
chennai |
| Type of Sponsor |
Other [Institution based research project] |
|
|
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 |
| Jogikalmat Krithikadatta |
Meenakshi Ammal Dental College |
Room No 9
Department of conservative dentistry
Chennai
TAMIL NADU |
9840111369
drkrithikadatta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Meenakshi Ammal Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Malocclusion, (1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitosan varnish |
Naturally derived biological agent used as varnish.
Applied weekly for 6 weeks |
| Comparator Agent |
Chlorhexidine varnish |
Cervitec F, Ivolcar varnish.
Applied weekly for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients undergoing fixed orthodontic therapy in the age group of 16 - 32 years
2. Maxillary arch with permanent dentition.
3. Patients undergoing orthodontic treatment with fixed appliances with conventional metal brackets.
4. Patients with good oral hygiene and with no incipient carious lesion.
5. Patients providing informed consent
6. Patients under 18 years informed consent will be obtained from their parents.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases, fluorosis.
2. Patients on metal self-ligating or ceramic brackets.
3. Patients with periodontitis with probing depth > 4mm
4. Patients taking antibiotics 3 months prior to the study
5. Smokers, pregnant ladies.
6. Patient with cleft lip, cleft palate and other dento-facial abnormalities.
7. Other oral fixed appliances.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of biofilm formation using Bonded Bracket Index (Plaque index) following the use of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy. |
0 Week (T0)
1 Week (T1)
2 Weeks (T2)
3 Weeks (T3)
4 Weeks (T4)
5 Weeks (T5)
6 Weeks (T6)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Quantitative assessment of S. mutans following the application of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy.
b. Estimation of plaque pH following the application of chitosan varnish or chlorhexidine varnish in patients undergoing fixed orthodontic therapy.
|
0 Week (T0)
1 Week (T1)
2 Weeks (T2)
3 Weeks (T3)
4 Weeks (T4)
5 Weeks (T5)
6 Weeks (T6)
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/06/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we are assessing the biofilm formation following the application of a new Chitosan-based varnish in orthodontic patients. The clinical relevance of this trial is to study if inhibition of biofilm formation will render the tooth less prone to the development of white-spot lesions. |