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CTRI Number  CTRI/2021/09/036881 [Registered on: 27/09/2021] Trial Registered Prospectively
Last Modified On: 24/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of silver diamine fluoride as a cleaning agent against primary teeth root canal 
Scientific Title of Study   Evaluation of anti-microbial efficacy of 3.8% silver diamine fluoride as root canal irrigant against Enterococcus faecalis in primary teeth: An in vivo study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vajrala Sasidhar 
Designation  Post Graduate 
Affiliation  GSL Dental College and Hospital 
Address  Room No 8 Dental Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry East Godavari ANDHRA PRADESH India

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9908243248  
Fax    
Email  sasidharvajrala@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Veena Arali 
Designation  Professor and Head of the Department 
Affiliation  GSL Dental College and Hospital 
Address  Room No 8 Dental Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry East Godavari ANDHRA PRADESH India

East Godavari
ANDHRA PRADESH
533296
India 
Phone  7760748787  
Fax    
Email  gslpedo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Veena Arali 
Designation  Professor and Head of the Department 
Affiliation  GSL Dental College and Hospital 
Address  Room No 8 Dental Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry East Godavari ANDHRA PRADESH India

East Godavari
ANDHRA PRADESH
533296
India 
Phone  7760748787  
Fax    
Email  gslpedo@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry 533296 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [None] 
 
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 
Vajrala Sasidhar  GSL Dental College and Hospital  Room No 8 Dental Department of Pediatric and Preventive Dentistry NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry East Godavari ANDHRA PRADESH India
East Godavari
ANDHRA PRADESH 		 9908243248

sasidharvajrala@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 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine gluconate  0.5 ml of 2% Chlorhexidine gluconate for 5 seconds will be used as an root canal irrigant. Chlorhexidine gluconate has antimicrobial property and is used as an irrigant in primary teeth. It has the property of substantivity. 
Intervention  Silver diamine fluoride  0.5 ml of 3.8% silver diamine fluoride for 5 seconds will be used as an root canal irrigant. Silver diamine fluoride has an antimicrobial property and is used as an irrigant in primary teeth. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Primary teeth of maxillary or mandibular, anterior/posterior containing at least one necrotic pulp canal, abscess, or sinus tract.
Presence of radiolucent area in furcation or periapical region.
At least two-thirds of the root remains.
Sufficient tooth structure to support a rubber dam.
 
 
ExclusionCriteria 
Details  Patients who had received antibiotics up to 2 weeks prior to the sampling or having any systemic compromise.
Patients who had non-restorable teeth, perforated pulpal floor, excessive mobility, or pathological root resorption.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Silver diamine fluoride may have better antimicrobial
property than Chlorhexidine gluconate as an
irrigant in primary teeth. 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Chlorhexidine gluconate may have better antimicrobial
property than Silver diamine fluoride as an irrigant in
primary teeth. 		 1 year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   02/10/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/10/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 02-08-2022 and end date provided 02-08-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   An interventional, double-blinded, randomized parallel-group trial will be conducted in 60 teeth from the patients requiring pulpectomy of 3 to 8 years old after obtaining written informed consent from the parents of the child. 60 teeth requiring pulpectomy will be divided into two groups using the following irrigants: Group I (n=30 teeth): 2% Chlorhexidine gluconate and Group II (n=30 teeth): 3.8% Silver diamine fluoride. Appropriate local anesthesia will be given and the tooth will be isolated with a rubber dam. The gross carious tissue will be removed and initial access opening will be done with No. 3 round carbide bur. Working length will be determined with a preoperative intraoral periapical radiograph. The first microbiological sample will be obtained with 2 sterile absorbent paper points each for 30 seconds from the root canal (pre irrigation) and will be immediately immersed into a test tube with Brain Heart Infusion Broth (BHI). Conventional biomechanical preparation will be done up to 35 k-file. During instrumentation after each file, Group I: 0.5 ml of 2% Chlorhexidine gluconate for 5 seconds will be used as an irrigant and Group II: 0.5 ml of 3.8% Silver diamine fluoride for 5 seconds will be used as an irrigant. Final irrigation of canals will be done at the end of instrumentation and dried before obturating and a second microbiological sample will be collected with another 2 sterile absorbent paper points each for 30 seconds. The root canal will be filled with an obturating material and a postoperative intraoral periapical radiograph will be taken. The collected samples will be subjected to microbiological analysis to determine the number of colony-forming units against E. faecalis. The obtained results will be subjected to statistical analysis. 
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