| CTRI Number |
CTRI/2024/08/072820 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Probiotic
Preventive
Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of probiotics in clear aligner patients. |
|
Scientific Title of Study
|
Analysis of the antimicrobial activity of probiotics against oral pathogens on clear aligners using confocal laser scanning microscopy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikas Thakur |
| Designation |
PG student |
| Affiliation |
Institute of Dental Studies and Technologies (IDST) |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics Institute of Dental Studies and Technologies (IDST) Kadrabad Modinagar Ghaziabad Uttar Pradesh 201204
Kadrabad Modinagar Ghaziabad Uttar Pradesh 201204
Ghaziabad
UTTAR PRADESH
201204
India |
| Phone |
07982854234 |
| Fax |
|
| Email |
vikthaku1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Achint Juneja |
| Designation |
Professor |
| Affiliation |
Institute of Dental Studies and Technologies (IDST) |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics Institute of Dental Studies and Technologies (IDST) Kadrabad Modinagar Ghaziabad Uttar Pradesh 201204
Kadrabad Modinagar Ghaziabad Uttar Pradesh 201204
UTTAR PRADESH
201204
India |
| Phone |
9953241381 |
| Fax |
|
| Email |
dr.achintjuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikas Thakur |
| Designation |
PG student |
| Affiliation |
Institute of Dental Studies and Technologies (IDST) |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics Institute of Dental Studies and Technologies (IDST) Kadrabad Modinagar Ghaziabad Uttar Pradesh 201204
Kadrabad Modinagar Ghaziabad Uttar Pradesh 201204
UTTAR PRADESH
201204
India |
| Phone |
07982854234 |
| Fax |
|
| Email |
vikthaku1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Invisalign India LLP
Unit No.303, 3rd floor, Windfall Sahar Plaza
Andhere Kurla Road, Andheri(E)
Mumbai-400059, India |
|
|
Primary Sponsor
|
| Name |
Dr Vikas Thakur |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad Uttar Pradesh 201204 |
| 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 Vikas Thakur |
Institute of Dental Studies and Technologies (IDST) |
Department of Orthodontics and Dentofacial Orthopaedic Institute of Dental Studies and Technologies (IDST) Kadrabad Modinagar Ghaziabad Uttar Pradesh 201204
Ghaziabad
UTTAR PRADESH |
07982854234
vikthaku1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST Ethics Committee (EC/NEW/INST/2023/UP/0290) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clear Aligners with probiotics |
1. Gummies(probiotics) - to be taken orally, 1 chewie per day for one week.
2. Mouthwash(probiotics) - to be taken orally, 10 ml of undiluted for 30 seconds in the morning for one week.
3. Tablet(probiotics)- to be taken orally, 1 tablet per day for one week.
4. Drink(probiotics)- to be taken orally, 1 drink per day for one week.
Total duration will be 4 months |
| Comparator Agent |
Clear aligners without probiotics |
Probiotics create a biofilm, acting as a protective layer for oral tissues against the pathogens causing oral diseases. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Orthodontic treatment with clear aligners.
Complete permanent dentition (excluding third molars)
Good general health (no significant medical history or drug use during the last month).
No anti inflammatory or antibiotic medications taken in the month before the study.
No chewing gum or mouthwash used in the last week and during the study.
Habit of brushing twice daily with prescribed fluoride toothpaste.
Patient with good periodontal condition. |
|
| ExclusionCriteria |
| Details |
Presence of a systemic disease
Smoking habit
History of periodontal disease
Extensive dental restorations
History of antibiotics or any antibacterial mouth rinse product use during the last 6 weeks
Application of professional dental hygiene procedures in the last 3 months.
|
|
|
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 |
| Efficacy of different probiotics on biofilm formed around clear aligners |
T0- 7 days old aligners(control)
T1- Probiotics gummies for 7 days
T2- Probiotics rinse for 7 days (to be given after 14 days of washout period)
T3- Probiotic Tablets for 7 days(to be given after 14 days of washout period)
T4- Probiotics Yakult for 7 days (to be given after 14 days of washout period) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of different types of probiotics on biofilm formed around clear aligners using colony forming units
2. To compare the efficacy of different types of probiotics on biofilm formed around clear aligners using colony forming units
3. Quantitative analysis of biofilm formed around clear aligners after using different types of probiotics by confocal laser scanning microscopy. |
T0- 7 days old aligners(control)
T1- Probiotics gummies for 7 days
T2- Probiotics rinse for 7 days (to be given after 14 days of washout period)
T3- Probiotic Tablets for 7 days(to be given after 14 days of washout period)
T4- Probiotics Yakult for 7 days (to be given after 14 days of washout period) |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
31/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
• Twenty patients will be randomly selected who have opted for orthodontic treatment via clear aligners (Invisalign). Four different types of probiotics in the form of gummies, tablet, rinse and drink will be given to the patient. Dose of each probiotic will be explained to the patient. Each sample will be collected after 1 week from the patient. First week will be taken as a control group. After 1st week new set of aligner will be given for 7 days with probiotic 1 (gummies). After 7 days, old aligners will be taken as a test group. Same procedure will be followed with different probiotics i.e probiotic 2(tablet), probiotic 3(rinse) and probiotic 4(drink). A wash out period of 2 weeks between the two probiotics will be used to prevent mis-interpreting observations. From all the clear aligners, small discs will be punched out using aligner hole punch plier (eltee) from facial surface of upper first molar and lingual surface of the lower central incisor. Each patient will be providing us 20 disc, control(4) and test(16). Disc from control and test group will be evaluated and compared via CFU and CLSM. All the discs will be dipped in broth and incubated for 24 hours. Then we will plate it on agar for CFU. CFU counts will be compared between test and control to evaluate the efficacy of probiotics. Similarly, the absence of biofilms and live/dead bacteria will be analyzed by the CSLM LSM510/ConfoCor2 system. Disc will be stained with Fluorescent dye (green fluorescence). The absence of a fluorescent signal will prove absence of biofilms on the aligners. |