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CTRI Number  CTRI/2020/09/027990 [Registered on: 23/09/2020] Trial Registered Prospectively
Last Modified On: 17/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Zinc Oxide with Tea Tree oil as Root canal filling material over zinc oxide eugenol in Primary teeth 
Scientific Title of Study   Clinical and Radiographic evaluation of the Efficacy of Zinc Oxide with Tea Tree Oil as Obturation material In Primary Teeth - An invivo Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kallakuri Mounika 
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 Lakhshmipuram Jagannadhapuram Agraharam Rajahmundry

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9494363567  
Fax    
Email  mouni.k08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Veena Arali 
Designation  Professor and HOD 
Affiliation  GSL Dental College and Hospital 
Address  Room No 8 Dental Department of Pediatric and Preventive Dentistry GSL Dental College and Hospital NH-16 Lakhshmipuram Jagannadhapuram Agraharam Rajahmundry

East Godavari
ANDHRA PRADESH
533296
India 
Phone  7760748787  
Fax    
Email  gslpedo@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kallakuri Mounika 
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 Lakhshmipuram Jagannadhapuram Agraharam Rajahmundry

East Godavari
ANDHRA PRADESH
533296
India 
Phone  9494363567  
Fax    
Email  mouni.k08@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  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Kallakuri Mounika  GSL Dental College and Hospital  Room no 8 Dental Department of Pediatric and Preventive Dentistry NH 16 Jagannadhapuram Agraharam Lakshmipuram Rajahmundry 533296
East Godavari
ANDHRA PRADESH 		 9494363567

mouni.k08@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: R52||Pain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Zinc Oxide with Eugenol  This can be used as Obturating material in Primary teeth. Eugenol may inhibit periapical nerve activity.Eugenol is believed to be capable of causing persistent inflammation when used in endodontic sealers. At higher concentrations eugenol has been demonstrated to exhibit cytotoxic effects. 
Intervention  Zinc Oxide with Tea Tree Oil   This can be used as an obturating material in Primary teeth.Tea tree oil Suppress the cytokines, interleukin 1‐beta (IL‐1b), interleukin‐6 (IL‐6), interleukin‐10 (IL‐10), tumoral necrosis factor (TNF‐α), and Prostaglandin E2. It was proved to have antimicrobial properties against Escherichia coli, Haemophilus influenzae, Streptococcus pyogenes, and Streptococcus pneumoniae.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Patients with no systemic illness.
Primary teeth with at-least one necrotic canal, abscess, or sinus tract.
Primary teeth with presence of radiolucency in furcation region.
Primary teeth with at-least two thirds of its root length.
 
 
ExclusionCriteria 
Details  Primary teeth with any internal and external resorption of roots.
Teeth which are non restorable with perforated pulpal floor or mobility.
Primary teeth which are having root length less than two thirds of its length.
 
 
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 
Zinc Oxide with Tea Tree Oil may have better antimicrobial Property when compared to Zinc Oxide Eugenol.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Zinc Oxide with Eugenol may have better antimicrobial property when compared to Zinc Oxide with Tea Tree Oil  1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/10/2020 
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="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)?  

Brief Summary   An interventional, double blinded, randomised parallel group trial will be conducted in 30 teeth from the patients requiring pulpectomy of 3 to 8 years old after obtaining the written informed consent from the parents of child.  30 teeth requiring pulpectomy will be divided into two groups using following obturation materials: Group I  (n=15 teeth): Zinc oxide Eugenol as obturation material. Group II (n=15 teeth): Zinc Oxide with Tea Tree Oil as obturation material. Appropriate local anesthesia will be given and the tooth will be isolated with 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 by pre operative intra oral periapical radiograph. Conventional Biomechanical Preparation will be done upto 35 H file. During biomechanical preparation coupious irrigation will be done with. The root canal will be filled with a obturation material of their assigned groups. Post operative intraoral periapical radiograph will be taken  to check the quality of obturation. After confirming the quality of obturation Tooth is restored with permanent restoration followed Crown placement. 
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