| CTRI Number |
CTRI/2024/03/064553 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of Acidified Caesin Phosphopeptide Amorphous Calcium Phosphate Fluoride and Acidulated Phosphate Fluoride on remineralization of early enamel carious lesion |
|
Scientific Title of Study
|
Comparative evaluation of Remineralizing Potential of Acidified Caesin Phosphopeptide Amorphous Calcium Phosphate Fluoride and Acidulated Phosphate Fluoride on early enamel carious lesion -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 |
Rahmath Meeral P |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
162, Poonamallee High Road, Velappanchavadi, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
8637646685 |
| Fax |
|
| Email |
prahmath31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahmath Meeral P |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
162, Poonamallee High Road, Velappanchavadi, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
8637646685 |
| Fax |
|
| Email |
prahmath31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahmath Meeral P |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
162, Poonamallee High Road, Velappanchavadi, Chennai.
Chennai
TAMIL NADU
600077
India |
| Phone |
8637646685 |
| Fax |
|
| Email |
prahmath31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sivam Dental and Maxillofacial Clinic |
|
|
Primary Sponsor
|
| Name |
Dr Sasidharan S |
| Address |
Sivam Dental and Maxillofacial Clinic,
No 6 Mahalakshmi nagar, Guduvanchery 603202 |
| 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 Gowardhan |
Sivam Dental and maxillofacial clinic |
No 6 Mahalakshmi Nagar Main Rd Mahalakshmi Nagar Guduvancheri Tamil Nadu 603202
Chennai
TAMIL NADU |
8667718848
sivamclinics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NOC |
No Objection Certificate |
| SAVEETHA DENTAL COLLEGE INSTITUTIONAL HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Early enamel carious lesion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acidified CPP-ACPF group |
The conventional CPP-ACPF will be acidified to the pH of APF gel by using lactic acid and checked for its enhanced remineralizing activity by usage for a period of 6 months. |
| Comparator Agent |
APF gel group |
The conventional APF gel is used as a comparator by usage for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with ICDAS II code 1
2. Subjects with ICDAS II code 2
3. Those who have high caries prevalence experience. |
|
| ExclusionCriteria |
| Details |
1. Those with systemic disease
2. Those with special care needs children.
3. Caries with ICDAS II code more than 2.
4. Those who don’t give consent to participate. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reversal of early enamel lesion evaluated through ICDAS scores |
Reversal of early enamel lesion evaluated through ICDAS scores at month 6 and 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DMFS |
6 and 12 month |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="2"
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
|
The early carious lesions categorized with ICDAS scores 1 & 2 in the dentition of 6 years and above age group children will be recruited and one group will be treated with Acidified CPP-ACPF gel (study group) and the other with conventional APF gel (comparator group). Upon 6th month and 1 year of observation, the early carious lesion reversal is observed and recorded to see the remineralisation efficiency of the test and control agents. |