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CTRI Number  CTRI/2023/06/054321 [Registered on: 22/06/2023] Trial Registered Prospectively
Last Modified On: 25/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of retention rate and caries preventive effects of 2% Chitosan based pit and fissure sealants in permanent 1st molars - A Randomised Trial 
Scientific Title of Study   EVALUATION OF RETENTION RATE AND CARIES PREVENTIVE EFFECTS OF 2% CHITOSAN BASED PIT AND FISSURE SEALANTS IN PERMANENT 1ST MOLARS - A RANDOMISED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naina kumar 
Designation  Post graduate 
Affiliation  A B Shetty Memorial Institute of Dental Sciences 
Address  Door No 15, 4th floor Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, DERALAKATTE, MANGALORE Dakshina Kannada KARNATAKA 575018 INDIA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9119655559  
Fax    
Email  nainakumarmi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR MANJU R 
Designation  PROFESSOR AND HEAD OF DEPARTMENT 
Affiliation  A B Shetty Memorial Institute of Dental Sciences 
Address  DOOR NO 15, 4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE DAKSHINA KANNADA KARNATAKA 575018 INDIA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845451954  
Fax    
Email  hod.pedo.absmids@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  DR MANJU R 
Designation  PROFESSOR AND HEAD OF DEPARTMENT 
Affiliation  A B Shetty Memorial Institute of Dental Sciences 
Address  DOOR NO 15, 4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE DAKSHINA KANNADA KARNATAKA 575018 INDIA

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845451954  
Fax    
Email  hod.pedo.absmids@nitte.edu.in  
 
Source of Monetary or Material Support  
A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES 
 
Primary Sponsor  
Name  NAINA KUMAR 
Address  DOOR NO 15, 4TH FLOOR DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES, DERALAKATTE, MANGALORE DAKSHINA KANNADA KARNATAKA 575018 INDIA 
Type of Sponsor  Other [Self] 
 
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 
NAINA KUMAR  A B SHETTY MEMORIAL INSTITUTE OF DENTAL SCIENCES  Door No 15, 4th Floor, Department of Pediatric and Preventive Dentistry, A B Shetty Memorial Institute of Dental Sciences, DERALAKATTE, MANGALORE Dakshina Kannada KARNATAKA 575018 INDIA
Dakshina Kannada
KARNATAKA 
9119655559

nainakumarmi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, A B SHETTY MEMORIAL INSTITUTE O DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  children with deep pits and fissures 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  PREVENTIVE DENTAL TREATMENT  Pit and fissure sealant will be evaluated at 3 and 6 months after placement  
Comparator Agent  PREVENTIVE DENTAL TREATMENT  UNMODIFIED AND MODIFIED PIT AND FISSURE SEALANT ARE COMPARED ON THE BASIS OF RETENTION RATE AND CARIES PREVENTIVE EFFECTS 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  I.Healthy children aged between 6 and 10 years.
II.Children who are at moderate to high risk of caries lesion development.
III.Children with presence of early non-cavitated lesions on their permanent 1st molars.
Cooperative children with medical, fitness or intellectual impairment 
 
ExclusionCriteria 
Details  I.Uncooperative children
II. Children with molar incisor hypoplasia, dental fluorosis, or suspected deep caries lesions
III. Children enrolled in any fluoridation program
IV. Children with bruxism or parafunctional habits 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate retention rate of modified pit and fissure sealant at the interval of 3 and 6 months after placement  3 and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate caries preventive effect of modified pit and fissure sealant at the interval of 3 and 6 months after placement  3 and 6 months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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   N/A 
Date of First Enrollment (India)   15/07/2023 
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="30" 
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  

Dental caries is a multifactorial local disease resulting in destruction of the hard tissues of the teeth by metabolites produced by oral microorganisms.

  Dental sealants were introduced in the 1960s to help prevent dental caries, mainly in the pits and fissures of occlusal tooth surfaces.

  Occlusal surfaces of newly erupted permanent molars are considered more prone to carious process owing to the findings that plaque accumulation was higher and thicker in partly erupted teeth because of incomplete occlusal interdigitation, limited mechanical oral function and requirement of more intense plaque control in comparison to fully erupted teeth.

  It has been suggested that sealant placement should be done within four years of eruption based upon the premise that  tooth surfaces are likely to remain caries free if it has survived intact for more than four years following eruption.

  Strong antimicrobial properties are employed  by most commonly incorporated agents i.e., Fluoride and Chlorhexidine in resin materials initially which may get depleted over a period of time and they may also cause alteration of mechanical properties decreasing the bonding strength of resin materials significantly.

  Chitosan a naturally occurring biopolymer, has gained importance since the past few years owing to its natural organic nature, antioxidant , non-toxic, mucoadhesiveness, bacteriostatic and bactericidal properties. It alters the cellular permeability via interaction between cationic polysaccharide and anionic membranal components.

 Various in-vitro studies have been conducted estimating the properties of chitosan based pit and fissure sealant in which 2% chitosan showed better antibacterial efficacy compared to chitosan free control group. However, the efficacy of same in oral environment is yet to be evaluated. Therefore, this study aims to assess the efficacy of 2% chitosan based pit and fissure sealant clinically.

  In an in-vitro study chitosan/fluoride microparticles prepared by spray drying showed potential utility as vehicles to enhance fluoride retention and promote its controlled fluoride delivery in the oral cavity by increasing fluoride uptake from oral care products to provide increased protection against caries.

  Therefore, chitosan in resin based pit and fissure sealant may improve caries preventive effect of sealant by increasing fluoride uptake that is present in sealant and causing sustained delivery of same in oral cavity over a longer period of time.

 Hence, the study aims to clinically assess the retention rate and caries preventive effects of modified 2% (chitosan based) and unmodified resin pit and fissure sealant on newly erupted permanent 1st molars at the intervals of 3 and 6 months.


Study is a split-mouth study in which mandibular and maxillary permanent 1st molars on one side will receive unmodified pit and fissure sealant while mandibular and maxillary permanent 1st molars of other side will receive modified pit and fissure sealant in a same individual

GROUP I: 64 caries free permanent 1st molars (2 in each patient) of 32 children fulfilling inclusion criteria will be selected for application of Clinpro pit and fissure sealant (control group)

GROUP II: 64 caries free permanent 1st molars (2 in each patient) of 32 children fulfilling inclusion criteria will be selected for application of 2% Chitosan based Clinpro pit and fissure sealant (study group)

 Finally, the retention rate and caries preventive effects of both will be evaluated at 3 and 6 months after placement.


 
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