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
|
|
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
|
|
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 |