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CTRI Number  CTRI/2020/03/023686 [Registered on: 02/03/2020] Trial Registered Prospectively
Last Modified On: 25/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   comparison and evaluation of 2.5% sodium hypochlorite and aqueous ozone as root canal irrigants in primary teeth in terms of anti-microbial efficacy- a randomized controlled study  
Scientific Title of Study   comparative evaluation of anti-microbial efficacy of sodium hypochlorite and aqueous ozone as root canal irrigants in non- vital primary teeth- a randomized controlled study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harsha Sawant  
Designation  P.G. student 
Affiliation  V.S.P.M.s Dental College and Research Centre, Nagpur 
Address  dept no. 301, dept of pediatric and preventive dentistry,V.S.P.M.s dental college and research centre, digdoh hills, hingna road, Nagpur-

Nagpur
MAHARASHTRA
440019
India 
Phone  9819652520  
Fax    
Email  sayee20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devendra Nagpal 
Designation  Professor and Head 
Affiliation  V.S.P.M.s Dental College and Research Centre, Nagpur 
Address  dept no. 301, dept of pediatric and preventive dentistry,V.S.P.M.s dental college and research centre, digdoh hills, hingna road, Nagpur-

Nagpur
MAHARASHTRA
440019
India 
Phone  9764271839  
Fax    
Email  drdevendra19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harsha Sawant  
Designation  P.G. student 
Affiliation  V.S.P.M.s Dental College and Research Centre, Nagpur 
Address  dept no. 301, dept of pediatric and preventive dentistry,V.S.P.M.s dental college and research centre, digdoh hills, hingna road, Nagpur-


MAHARASHTRA
440019
India 
Phone  9819652520  
Fax    
Email  sayee20@gmail.com  
 
Source of Monetary or Material Support  
V.S.P.M. Dental College and Research Centre, Nagpur 
 
Primary Sponsor  
Name  Dr Harsha Sawant  
Address  dept no- 301, dept pediatric and preventive dentistry, V.S.P.M. Dental College, digdoh hills, hingna road, Nagpur  
Type of Sponsor  Other [investigator initiated trial] 
 
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 Harsha Sawant  V.S.P.M.s Dental College and Reasearch centre, Nagpur  dept no- 301, dept of pediatric and preventive dentistry.
Nagpur
MAHARASHTRA 
9819652520

sayee20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Of V.S.P.M.s Dental College and Research Centre,   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  non- vital primary teeth 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2.5% sodium hypochlorite  2.5% sodium hypochlorite will be used as root canal irrigant and will be used throughout the duration of biomechanical preparation during the pulpectomy procedure. it will contact the walls of root canal for 3- 10 mins 
Intervention  Aqueous ozone  aqueous ozone will be used in the concerntration of 24 micrograms/ml. It will be used as root canal irrigant throughout the duration of biomechanical preparation during the pulpectomy procedure. It will contact the walls of root canal for 3- 10 mins 
Comparator Agent  saline  saline will used as placebo  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  healthy children with the presence of necrotic pulp, with/ without the radiolucency in the furcation area, less than 2/3 root resorption 
 
ExclusionCriteria 
Details  any tooth found vital upon opening the pulp chamber and with history of antibiotic consumption within the past three months from time of diagnosis  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
anti- microbial efficacy  First sample will be collected At baseline after access opening and immediately after biomechanical preparation in the same appointment second sample will be collected 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not aaplicable 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   02/03/2020 
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="1"
Months="6"
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  
The bacteria present in infected root canals include a restricted group of species compared with the total flora of the oral cavity. The bacterial species in root canals may vary, and the number of bacterial cells recovered are between < 10 2 to > 10 8[1].
Black-pigmented bacilli (BPB) have frequently been isolated from root canals along with Streptococci in 70%- 82% of the root canals of deciduous teeth with pulp necrosis[2]. The anaerobiosis is broken when the canal is opened and biomechanical treatment eliminates bacteria as well as deprives the canal of nutrients and interferes with bacterial interactions[1].
Sodium hypochlorite (NaOCl) is reported to kill the target microorganisms in seconds, even at low concentrations. Continuous irrigation and time are important factors for the effectiveness of hypochlorite[3]. It has been shown that using 0.5% or 5% NaOCl, with or without EDTA for irrigation, resulted in considerable reduction of bacterial counts in the canal when compared with irrigation with saline but it was difficult to render the canals completely free from bacteria, even after repeated sessions[4].
The disadvantages of NaOCl include the unpleasant taste, toxicity, and its inability to remove the smear layer by itself, as it dissolves only organic material[5]. The limited antimicrobial effectiveness of NaOCl in vivo is also disappointing because of poor penetration to the most peripheral parts of the root-canal system such as fins, anastomoses, apical canal, lateral canals, and dentin canals. Also, the presence of organic materials like exudate from the periapical area, pulp tissue, dentin collagen, and microbial biomass counteract the efficacy of NaOCl[3]. Recently, it has been shown by in vitro studies that long-term exposure of dentin to a high concentration sodium hypochlorite can have a detrimental effect on dentin elasticity and flexural strength increasing the risk of vertical root fracture[6][7]. However, use of hypochlorite as the final rinse following EDTA or citric acid (CA) rapidly produces severe erosion of the canal-wall dentin and should probably be avoided[8].
Edward Fisch (1932) was the first to use ozone to control infection in regular dental practice. Ozone(O3) is energized form of oxygen which is unstable and dissociates readily back to oxygen (O2) and singlet oxygen (O) which is a strong oxidizing agent[9].
There are three basic forms of ozone application.
1) Ozone gas
2) Ozonated water
3) Ozonated oil.
These forms of application are used singly or in combination to treat dental disease. Ozone gas has a half life of about 5-30 min and Ozonated water has a life span of about 10 hrs if the water is kept cold[10].
It has been proved that ozonated water (0.5–4 mg/l) was highly effective in killing both gram-positive and gram-negative oral microorganisms. Among them, the gram-negative bacteria, such as the endodontopathic bacterium P. endodontalis and the periodontopathic bacterium P. gingivalis, were substantially more sensitive to ozonated water than the gram-positive oral streptococci[11].
The advantages of ozone in the aqueous phase are its potency, ease of handling, lack of mutagenicity, rapid microbicidal effects[12]. Also, aqueous ozone fulfils optimal cell biological characteristics in terms of biocompatibility for oral application.
Therefore the purpose of this study is to evaluate and compare the anti- microbial efficacy of sodium hypochlorite and aqueous ozone against the bacteria found in the non- vital tooth which are- anaerobes like black pigmented bacilli (P.Gingivalis, Prevotella, P. Micros), E. Faecalis and aerobes- streptococcus species. this study was planned with hypotheses of significant difference in anti- microbial efficacy of aqueous ozone in comparison to NaOCl as root canal irrigant in non-vital primary teeth
 
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