| CTRI Number |
CTRI/2022/07/043628 [Registered on: 01/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A new Innovative Oral Bioadhesive Formulation Incorporated With Nano Hydroxyapatite and Acorus Calamus Rhizome Extract To Enhance Remineralization of White Spot Lesions during braces Treatment – A Randomized Controlled Trial. |
|
Scientific Title of Study
|
A NOVEL ORAL BIOADHESIVE FORMULATION INCORPORATED WITH NANO
HYDROXYAPATITE AND ACORUS CALAMUS RHIZOME EXTRACT TO
COMBAT WHITE SPOT LESION- A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jerusha T |
| Designation |
Post Graduate Student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Orthodontics
SS Nagar
Bannimantap
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
9344989023 |
| Fax |
|
| Email |
jerushat77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suma S |
| Designation |
Reader |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Orthodontics
SS Nagar
Bannimantap
Mysore
Mysore
KARNATAKA
570015
India |
| Phone |
8310099013 |
| Fax |
|
| Email |
dr.suma@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jerusha T |
| Designation |
Post Graduate Student |
| Affiliation |
JSS Dental College and Hospital |
| Address |
Department of Orthodontics
SS Nagar
Bannimantap
Mysore
KARNATAKA
570015
India |
| Phone |
9344989023 |
| Fax |
|
| Email |
jerushat77@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Jerusha T |
| Address |
PG Student
Department of Orthodontics and Dentofacial Orthopedics
SS Nagar
Bannimantap
Mysore |
| 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 |
| Dr Jerusha T |
Department of orthodontics, Room number 11, JSS Dental College and Hospital, Mysore |
SS Nagar
Bannimantap
Mysore
Mysore
KARNATAKA |
9344989023
jerushat77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bio adhesive placement during Orthodontic Treatment |
9-12 months |
| Comparator Agent |
Regular Orthodontic patients without any type of bioadhesive formulation. |
9-12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged 18-25 years.
2. Healthy subjects with no other systemic diseases
3. Individuals undergoing fixed orthodontic treatment
|
|
| ExclusionCriteria |
| Details |
1. Subjects with systemic diseases
2. Individuals under any medication.
3. Individuals with high caries risk
4. Periodontally compromised individuals
5. Individuals unwilling to participate in the study
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To prepare an oral bioadhesive formulation with the use of nano hydroxyl apatite and herbal extract separately and in combination
To evaluate its efficacy in remineralization of white spot lesion. |
Total Duration of 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the usability of Oral Bio adhesive for other than treating White spot lesion |
18 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
01/07/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Description
of Materials used:
Synthetic
biomimetic Hydroxyapatite which has nano sized particles, in the powder form is
to be purchased from outside source. The extract of the rhizome of Acorus
calamus is to be done in the department of pharmacognosy,JSS College of
Pharmacy. Acorus calamus alcoholic and aqueous extracts will be prepared by SOXHLET
extraction and hot extraction process (refluxation). The MIC of the Acorus
calamus rhizome extract on the microorganisms causing white spot lesion i.e.
Streptococcus mutans and Lactobacilllus acidophilus will be evaluated. After
the preparation of the oral bioadhesive formulation, 10% Nano Hydroxyapatite
and/or rhizome extract of Acorus calamus will be incorporated into it.
Investigations
to be done:
Biochemical
analysis of saliva will be done to assess pH, Calcium and Phosphate levels.
This is done in 3 phases for all the subjects. First before starting fixed
orthodontic treatment which will be used as Baseline data, second during the
mid-phase of the treatment and then third after completion of the treatment.
Procedure:
Randomization
and group allocation: Eligible forty participants will be randomly selected and
allocated to four different categories.
Group A:
Oral bioadhesive formulation containing 10% Nano Hydroxyapatite.
Group B:
Oral bioadhesive formulation containing rhizome extract of Acorus calamus.
Group C:
Oral bioadhesive formulation containing both 10% Nano Hydroxyapatite and
rhizome extract of Acorus calamus.
Group D:
Control group.
Participants
will be instructed to maintain good oral hygiene status. The participants will
be asked to report immediately in case of any adverse effects to the contact
details of investigator provided to him/ her.
Intervention:
After bonding of orthodontic brackets, each
patient in the test group will be given oral bioadhesive formulation. |