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CTRI Number  CTRI/2023/06/053795 [Registered on: 13/06/2023] Trial Registered Prospectively
Last Modified On: 03/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Preventive
Dentistry 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   Tooth cavity disinfetion with Chitosan solution in 5-12 year old children 
Scientific Title of Study   Clinical Evaluation of the efficacy of Phosphorylated Chitosan as Cavity Disinfectant in Carious Primary Molars 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sreejeeta Dey 
Designation  Post graduate student 
Affiliation  JSS Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Room no.5 JSS Dental college and hospital,Mysore Bangalore road,Bannimantap,SS Nagar Mysore

Mysore
KARNATAKA
570015
India 
Phone  9108456886  
Fax    
Email  dsreej@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Deshmukh 
Designation  Reader 
Affiliation  JSS Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Room no.5 JSS Dental college and hospital Mysore Bangalore road,Bannimantap,SS Nagar Mysore

Mysore
KARNATAKA
570015
India 
Phone  8880505064  
Fax    
Email  seema.pedo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sreejeeta Dey 
Designation  Post graduate student 
Affiliation  JSS Dental College and Hospital 
Address  Department of Pediatric and Preventive Dentistry, Room no.5 JSS Dental college and hospital Mysore Bangalore road,Bannimantap,SS Nagar Mysore

Mysore
KARNATAKA
570015
India 
Phone  9108456886  
Fax    
Email  dsreej@gmail.com  
 
Source of Monetary or Material Support  
JSS Dental college and hospital 
 
Primary Sponsor  
Name  Dr Sreejeeta Dey 
Address  Jss dental college and hospital Department of Pediatric and Preventive Dentistry 
Type of Sponsor  Other [Self-funded] 
 
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 
Dr Sreejeeta Dey  JSS DENTAL COLLEGE AND HOSPITAL  Department of Pediatric and Preventive Dentistry, Room no.5 JSS Dental college and hospital, Mysore Bangalore road, Sri Shivarathreeshwara Nagara, Bannimantap, Mysuru, Karnataka 570015
Mysore
KARNATAKA 
9108456886

dsreej@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS Dental College and Hospital Institutional Ethics Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  dental caries 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2% chlorhexidine  Consepsis,Ultradent 
Intervention  Phosphorylated chitosan  low molecular weight chitosan from Sigma aldrich 5% (w/v) of chitosan dissolved in 0.5% (v/v) acetic acid solution, followed by addition of 25 g of urea and 50 ml of N, N dimethylformamide. Then 4 ml of phosphoric acid to be added to the chitosan solution. The mixture is reacted at 1500c of 1 hour. After cooling the reaction mixture is filtered. The obtained precipitate is washed thoroughly with 40% ethanol and then dried at room temperature 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Mandibular and maxillary primary molars
2.Moderately deep cavities (ICDAS II caries score 4,5,6) limited to single-surface occlusal lesions and two-surface lesions (mesial-occlusal, MO or distal-occlusal, DO) without buccal/lingual extension
3.systemically healthy and cooperative children(Frankl scale 3 and 4)
Radiographic criteria:
4.Lesions involving enamel and not more than half the dentinal thickness with two-third of remaining root length
 
 
ExclusionCriteria 
Details  1.Systemic illness
2.Patients undergoing orthodontic treatment
3.Carious lesions involving pulp with/without root resorption and mobility
4.Re-restorations/hypomineralised teeth
5.Uncooperative patients(Frankl scale 1 and 2)
Withdrawal criteria:
6.Development of allergy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess & compare the increase or decrease in bacterial activity with the use of p-chitosan & conventional chlorhexidine cavity disinfectants by measuring mean carious lesion area using fluorescence image analysis  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate & compare the efficacy of p-chitosan cavity disinfectant with that of conventional chlorhexidine disinfectant in the retention and longevity of a dental restoration using FDI clinical scoring criteria  6 months 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/06/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Dental caries is the among the commonest and highly prevalent diseases worlwide affecting 486million children with primary teeth and 2.4billion adults with permanent teeth globally.According to WHO, dental caries affects 60–90 % of schoolchildren globally, mainly in developing countries resulting in pain,infections,undernutrition thereby affecting growth and development and decrease in overall quality of life.Therefore it is of utmost importance to treat effectively and prevent dental caries from progressing, at an earlier stage, to avoid all the complications.The ideal way of treating moderately affected carious tooth is by removing the bacteria by cavity preparation followed by a cement or resin-based dental restoration.

However,the complete eradication of bacteria prior to insertion of restoration plays an important role in determining the longevity of the restoration and correspondingly the success of the treatment. Bacteria can remain viable on the dentinal surface even after cavity preparation. They may survive and multiply in the presence of microleakage, which may lead to pulpal irritation, risk of recurrent caries and/or postoperative sensitivity and ultimately failure of the restoration. Attempts at the complete removal of deep carious dentin, by solely mechanical means, may result in pulp exposure and gross destruction of the tooth structure.

To cope up with the above drawbacks, the concept of cavity disinfection has been introduced by some authors, which involves cleansing of the cavity with antimicrobial agents prior to placement of restoration. Multiple disinfectants(CHX,NaOCl,Laser,Ozone,Propolis etc.) have been used in clinical dentistry, to reduce or eliminate bacterial load and sterilize dentin during cavity preparation.

Chlorhexidine digluconate in the form of 2% aqueous solution has been  widely considered as a  biocompatible,effective and toxicologically safe disinfectant.

Chitosan, derived from the deacetylation of chitin, obtained from the shells of marine crustaceans is a natural nontoxic, biocompatible, biodegradable polysaccharide with tested antibacterial properties. Prior studies have described the antimicrobial potential of chitin, chitosan, and their derivatives against Streptococcus mutans and other streptococci bacteria. Among these derivatives, phosphorylated chitosan(p-chitosan) exhibits bactericidal, bioabsorbable, osteoinductive, and metal chelating properties. Since phosphate groups of p-chitosan can bind calcium ions to form nucleating sites, p-chitosan would induce the formation of a calcium phosphate layer favouring remineralization of the carious lesion.

The aim of the present study is to evaluate the efficacy of p-chitosan as a potential cavity disinfectant which can decrease the bacterial load in the cavity and asses using fluorescence imaging and also compare the results with that of conventional 2%chlorhexidine disinfectant in retention and longevity of restorations. 
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