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CTRI Number  CTRI/2020/01/022962 [Registered on: 27/01/2020] Trial Registered Prospectively
Last Modified On: 15/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the effectiveness of two methods of remineralisation using CPP-ACP varnish on white spots on teeth 
Scientific Title of Study   A Comparative evaluation of efficacy of CPP-ACP varnish with and without papain gel on the remineralisation of white spot lesions using laser fluorescence 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geetika Gupta 
Designation  junior resident 
Affiliation  King Georges Medical University,Lucknow, UP 
Address  Department of paediatric and preventive dentistry Faculty of dental sciences King Georges Medical University,Lucknow, UP

Lucknow
UTTAR PRADESH
226003
India 
Phone  8218699652  
Fax    
Email  geet1025@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Afroz Alam Ansari 
Designation  Professor  
Affiliation  King Georges Medical University,Lucknow, UP 
Address  Department of paediatric and preventive dentistry Faculty of dental sciences King Georges Medical University,Lucknow, UP

Lucknow
UTTAR PRADESH
226003
India 
Phone  9335166662  
Fax    
Email  afrozalamansari@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Afroz Alam Ansari 
Designation  Professor  
Affiliation  King Georges Medical University,Lucknow, UP 
Address  Department of paediatric and preventive dentistry Faculty of dental sciences King Georges Medical University,Lucknow, UP


UTTAR PRADESH
226003
India 
Phone  9335166662  
Fax    
Email  afrozalamansari@rediffmail.com  
 
Source of Monetary or Material Support  
King Georges Meidcal University, Lucknow , U.P 
 
Primary Sponsor  
Name  King Georges Medical University 
Address  King Georges Medical University, Lucknow 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
geetika gupta  out patient department   department of paediatric and preventive dentistry,faculty of dental sciences, king georges medical university
Lucknow
UTTAR PRADESH 		 8218699652

geet1025@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  preventive and screening interventions (teeth with incipient lesions) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CPP-ACPF varnish  Application of only CPP-ACPF varnish on white spot lesions on white spot lesions on teeth on the first appointment and recording change in diagnodent reading on follow up visits 
Intervention  CPP-ACPF varnish with papain gel  Application of CPP-ACPF varnish after applying papain gel on white spot lesions on teeth on the first appointment and recording change in diagnodent reading on follow up visits 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Teeth with white spot lesions due to poor oral hygiene
prolonged plaque accumulation and teeth undergoing fixed orthodontic treatment.
Patients not using any extensive fluoride regimes. 
 
ExclusionCriteria 
Details  Teeth with caries activity or periodontal disease
Teeth with associated developmental abnormalities like amelogenesis imperfecta, dentinogenesis imperfecta.
Teeth with fluorosis.
Teeth with hypoplastic white spots.
Patients with history of xerostomia.
Patients who are on any medications that alter the salivary flow.
Patients with hypoplastic enamel defects, cleft lip and palate deformities, orofacial syndrome, other syndromes and multiple restorations on the facial surfaces and
patients with a known history of allergy to milk protein.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in DIAGNOdent readings of wgite spot lesions  9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Surface changes in enamel using Scanning Electron Microscopy  3 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   30/01/2020 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
This study is a randomized, single blind  trial comparing the remineralisng efficacy of CPP-ACPF varnish with and without papain gel on white spot lesions using laser fluorescence and Scanning Electron Microscopy (SEM).. A minimum of 66 teeth will be enrolled in the study which will be followed up till 9 months  and the primary outcome will be change in diagnodent reading (laser fluorescence) which suggests change in mineral content. The secondary outcome will be qualitative evauation using SEM.
 
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