| CTRI Number |
CTRI/2023/07/055073 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of two different remineralising agents on white spot lesions |
|
Scientific Title of Study
|
Comparative evaluation of two different types of remineralizing agents for treatment of white spot lesions in patients undergoing orthodontic treatment: Randomized control 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 |
Kavitha Ramsundar |
| Designation |
PG |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Orthodontics,
Room no: 27, Dental block, No.162, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur TAMIL NADU 600077 India
Department of Orthodontics,
Room no: 27, Dental block, No.162, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7358202487 |
| Fax |
|
| Email |
kavitharamsundar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravindra Kumar Jain |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Orthodontics,
Room no: 27, Dental block, No.162, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Department of Orthodontics,
Room no: 27, Dental block, No.162, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur
TAMIL NADU
600064
India |
| Phone |
9884729660 |
| Fax |
|
| Email |
ravindrakumar@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha Ramsundar |
| Designation |
PG |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Orthodontics,
Room no: 27, Dental block, No.162, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Department of Orthodontics,
Room no: 27, Dental block, No.162, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7358202487 |
| Fax |
|
| Email |
kavitharamsundar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swiss Made Direct,
Business Park, Luzern,
Littauerboden 1, 6014 Luzern, Switzerland. |
|
|
Primary Sponsor
|
| Name |
Phosphenes Private Limited |
| Address |
10,Prakasam street,Janaki nagar, Valasaravakkam,Chennai-600087 |
| Type of Sponsor |
Other [Private Industrial Organisation] |
|
|
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 |
| Kavitha Ramsundar |
Saveetha dental college and hospitals |
Department of Orthodontics,
Room no: 27, Dental block, No.162, Saveetha Dental College and Hospital, Poonamallee High Road, Velappanchavadi, Chennai.
Thiruvallur
TAMIL NADU |
7358202487
kavitharamsundar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curodont Repair |
2 pea-sized pumps of Topical gel to be applied twice a week on the enamel surfaces with white spot lesions post debonding |
| Comparator Agent |
GC Tooth mousse |
2 pea-sized pumps of Topical gel to be applied twice a week on the enamel surfaces with white spot lesions post debonding |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Teeth diagnosed with white spot lesions after debonding the fixed orthodontic appliances to be included
2. In patients Between 18-30 years of age
3. Symmetrical number of permanent teeth in each arch.
|
|
| ExclusionCriteria |
| Details |
1. Active carious lesions.
2. Facial surface restorations
3. Deciduous teeth
4. Fluorosis
5. Intrinsic and extrinsic stains |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| White spot lesions regression |
At 0, 3, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="284"
Sample Size from India="284"
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 3 |
|
Date of First Enrollment (India)
|
20/07/2023 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To compare the efficiency of self assembling peptide based remineralising cream and hydroxyapatite base remineralising agent for treatment of white spot lesions. Methodology: Patients who have white spot lesions post debonding of fixed orthodontic appliance to be recruited in the study and the below mentioned remineralising agents to be applied on the teeth with white spot lesions Group 1: CURODONT weekly twice, self application Group 2: GC Tooth mousse weekly twice, self application Followup: at 3 months and 6 months Evaluation: ICDAS scores on photographs and SEM (Scanning Electron Microscopy) Analysis of the putty (polyvinyl siloxane) impression taken in WSL(white spot lesion) patients to study the extent of WSL (pre and post). |