| CTRI Number |
CTRI/2025/02/080119 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
visual and photographic assessment of remineralization of white spot lesion on primary front teeth intervention using self assembling peptide and sodium fluoride varnish in 3 to 6 years children A comparitive randomized clinical study |
|
Scientific Title of Study
|
Visual And Photographic Assessment Of Remineralizing Efficacy Of Self Assembling Peptide And Sodium Fluoride Varnish On White Spot Lesions In Primary Anterior Teeth: A Comparative Randomized Clinical Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shwetha N |
| Designation |
Post Graduate Student |
| Affiliation |
Government dental college and research institute |
| Address |
Deparment of pediatric and preventive dentistry,Government dental college and research institute, Bangalore, Victoria hospital campus
Bangalore KARNATAKA 560002 India |
| Phone |
07026747822 |
| Fax |
|
| Email |
shwethan31598@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr J Nagarathna |
| Designation |
Assistant Professor |
| Affiliation |
Government dental college and research institute |
| Address |
Deparment of pediatric and preventive dentistry, Government dental college and research institute, Bangalore, Victoria hospital campus
Bangalore KARNATAKA 560002 India |
| Phone |
9449631391 |
| Fax |
|
| Email |
nagarathnagiri_1975@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr J Nagarathna |
| Designation |
Assistant Professor |
| Affiliation |
Government dental college and research institute |
| Address |
Deparment of pediatric and preventive dentistry, Government dental college and research institute, Bangalore, Victoria hospital campus
KARNATAKA 560002 India |
| Phone |
9449631391 |
| Fax |
|
| Email |
nagarathnagiri_1975@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Dental College and research institute, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Shwetha N |
| Address |
Depart of pediatric and preventive dentistry, Government dental college and research institute, KR market , Bangalore |
| Type of Sponsor |
Other [nil] |
|
|
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 J Nagarathna |
Government dental college and research institute |
Deparment of pediatric and preventive dentistry ,government dental college and research institute , bangalore , victoria hospital campus
beside victoria hospital b block ,k r market Bangalore KARNATAKA |
9449631391
nagarathnagiri_1975@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government dental college and research institute bangalore institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
white spot lesions on primary anterior teeth |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Self assembling peptide |
application of self assembling peptide on white spot lesions on primary anterior teeth, photographs are taken pre and post intervention. |
| Comparator Agent |
sodium fluoride varnish |
application of sodium fluoride varnish at 6month and 12 months and photographs are taken pre and post intervention. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
• Co-operative children, aged 3-6 years with primary dentition .
• Teeth presenting at least one non-cavitated, active( whitish opaque appearance with rough surface), visible with or without air drying .
• The initial caries of ICDAS II score 1 or 2 on labial aspect of primary anterior teeth.
• Subjects with no systemic diseases or medications affecting salivary flow.
• Subjects with photographs of high image quality.
|
|
| ExclusionCriteria |
| Details |
• Subjects who had history of professional topical fluoride application or use of any remineralizing agents .
• Subjects who have GIC restorations adjacent to tooth with the white spot lesions .
• Subjects under tetracyclines or any other medications known to cause stains, had enamel hypoplasia, fluorosis or other developmental defects .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. increase or decrease in area of white spot lesion pre and post intervention. |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in appearence of white spot lesions in pre and post photographs |
1year 6months |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2025 |
| 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 Yet Recruiting |
| 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
|
Early childhood caries(ECC) is a biofilm-mediated, multifactorial, dynamic disease induced
by the imbalance between
demineralization and remineralization of dental hard tissues.1 Caries progress when the equilibrium of demineralization and
remineralization is tilted, leading to net mineral loss and white spot lesion(WSLs) formation.2 Since
a lower level of mineralization and the thin enamel make primary teeth more susceptible to caries formation,
effective control of initial lesions before cavitation is of utmost importance.3
Remineralization of the initial lesion is
always a viable option that arrests or reverses the caries process at a lesion level which reduces the loss of
sound tooth structure.4 Sodium
fluoride varnish(NaF) is a professionally
used topical fluoride preparation that is simple,
relatively inexpensive and effective in controlling
the progression of WSLs.5
However, it has been claimed that the effect of fluoride is limited to the outer 30um and does not enter a
deeper subsurface demineralized zone, where remineralization is much needed for the affected
enamel.6
Owing to
this limitation seeking an alternative that diffuses deeply into the subsurface caries in a biomimetic
way similar to the natural remineralization could be valuable. One such is the
Self-assembling peptide(SAP11-4) which mimics the action of natural enamel proteins that aid in guided enamel regenerartion.7 Several methods exist for the
detection and assessment of WSLs, visual and tactile method is commonly used for detection and
photography is simple and effective for assessment. There are limited clinical studies evaluating the efficacy of
SAP11-4 and NaF on primary
teeth, henceforth this study is undertaken. |