| CTRI Number |
CTRI/2025/04/083789 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enamel Remineralization in Clear Aligner Patients Using a Novel Remineralizing Solution: A Clinical Study |
|
Scientific Title of Study
|
Evaluation of Enamel Remineralization Using a Novel Remineralizing Solution in patients undergoing Clear Aligner Therapy - A Randomized 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 |
Siddhant Umesh Thorat |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College |
| Address |
Department of orthodontics, Saveetha Dental College and Hospital, Chennai
162, Poonamallee High Rd, Velappanchavadi
Department of orthodontics, Saveetha Dental College and Hospital, Chennai, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9769061211 |
| Fax |
|
| Email |
siddhantut@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Navaneethan R |
| Designation |
Professor |
| Affiliation |
SAVEETHA DENTAL COLLEGE |
| Address |
Department of Orthodontics, Saveetha Dental College and Hospital, 162, Poonamallee High Rd, Velappanchavadi
Department of Orthodontics, Saveetha Dental College and Hospital, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9962787531 |
| Fax |
|
| Email |
navaneethan@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Navaneethan R |
| Designation |
Professor |
| Affiliation |
SAVEETHA DENTAL COLLEGE |
| Address |
Department of Orthodontics, Saveetha Dental College and Hospital, 162, Poonamallee High Rd, Velappanchavadi
Department of Orthodontics, Saveetha Dental College and Hospital, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9962787531 |
| Fax |
|
| Email |
navaneethan@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Zendura, Bay Materials LLC
48450 Lakeview Blvd
Fremont, CA 94538 |
|
|
Primary Sponsor
|
| Name |
Umesh Thorat |
| Address |
204, RS Sampada, Arunodaya Nagar, Mulund East, Mumbai- 81 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Saveetha Dental College and Hospital |
No 162, Poonamallee high RoadVelappanchavadi, Chennai 600077 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Siddhant Thorat |
Saveetha Dental College and Hospitals |
Department of Orthodontics, Saveetha Dental College and Hospital, 162, Poonamallee High Rd, Velappanchavadi
Chennai
TAMIL NADU |
09769061211
siddhantut@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDC IHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aligner trays with Novel Remineralizing Solution |
Patients undergoing aligner treatment will be asked to use a novel remineralizing solution on the active surface of their trays following an application protocol. The application protocol will specify dosage (5ml per spray), frequency (twice a day), and duration of contact (22 hours/ day of aligner wear), with precautions to maximize effectiveness in conjugation with a fixed routine oral hygiene protocol. |
| Comparator Agent |
Aligner Trays without any remineralizing agent application |
Patients undergoing clear aligner therapy in the comparator group will follow a fixed routine oral hygiene protocol without the use of the novel remineralizing solution. This standardized regimen will include brushing twice daily with fluoride toothpaste, using a fluoride-containing mouth rinse, and flossing or using interdental cleaners as recommended. Participants will be instructed to adhere strictly to these oral hygiene practices to ensure a consistent baseline for comparison. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
The patients age range between the age from 14 to
40 years old
Gender can be males or females
Good oral hygiene with a plaque index score 0 or 1 good general health
patient compliance
Active noncavitated carious white spot lesions
Undergoing clear aligner therapy treatment
No systemic diseases or concomitant medication affects salivary fow in order not to negatively affect the remineralizing process |
|
| ExclusionCriteria |
| Details |
Patients undergoing conventional orthodontic treatment
Age outside 14 to 40 years
Systemic diseases or medication
Smoking or tobacco use
Pregnancy and lacation |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enamel remineralization potential |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Colour stability |
15 days of aligner use |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [siddhantut@gmail.com].
- For how long will this data be available start date provided 15-02-2025 and end date provided 15-05-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - No
|
|
Brief Summary
|
Comparative Evaluation of Enamel Remineralization Using Aligner Trays with Novel Remineralizing Solutions Versus Alilgner Trays Without Remineralizing Agents- A Randomized Controlled Trial
Aim: The aim of this study is to evaluate and compare the enamel remineralization potential of aligner trays used in conjunction with a novel remineralizing solution versus those used without any remineralizing agent. Objectives: To formulate a novel remineralizing solution containing Bioactive glass To assess cytotoxicity and antibacterial activity of the novel solution. To assess the remineralizing potential of the novel solution. To assess the effect of physical and chemical properties of aligner material on exposure to novel remineralizing solution To compare and evaluate the difference in the enamel remineralizing potential of the aligner trays used with a novel enamel remineralizing solution with those used without any remineralizing agent.
Sample Size: 20
Methodology The methodology involves synthesizing a Bioglass based novel remineralizing solution. The sample size, determined using G*Power version 3.0.1 with a power of 0.8, consists of 20 patients undergoing clear aligner therapy. The study adopts a randomized controlled trial design with an intervention group exposed to the remineralizing solution along with normal oral hygiene procedures and the control group with just the normal oral hygiene procedures. Patients will be informed about the application protocol for the solution and a fixed routine oral hygiene procedure will be followed in both groups. After 3 months, the teeth from both groups will be evaluated for enamel remineralization. Additional assessment will include the color stability of the aligner trays. Informed consent will be obtained from all participants for the use of their case records in research and publication.
|