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CTRI Number  CTRI/2018/02/012107 [Registered on: 23/02/2018] Trial Registered Retrospectively
Last Modified On: 12/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial to compare the effectiveness of different irrigation methods in endodontic treatment in patients with infection beyond the root apex. 
Scientific Title of Study   A randomized controlled trial of endodontic treatment using ultrasonic irrigation and laser activated irrigation to evaluate healing in chronic apical periodontitis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akansha Verma  
Designation  Junior Resident 1 
Affiliation  King George Medical University 
Address  Department of Conservative Dentistry and Endodontics King George Medical University, Faculty of Dental Sciences Lucknow.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9717877391  
Fax    
Email  akansha291@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakesh Kumar Yadav 
Designation  professor 
Affiliation  King George Medical University 
Address  Department of Conservative Dentistry and Endodontics King George Medical University, Faculty of Dental Sciences Lucknow.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9648077421  
Fax    
Email  rakeshanita10@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vijay Shakya 
Designation  Assistant Professor 
Affiliation  King George Medical University 
Address  Department of Conservative Dentistry and Endodontics King George Medical University, Faculty of Dental Sciences.

Lucknow
UTTAR PRADESH
226003
India 
Phone  9452278876  
Fax    
Email  dr.vijay.shakya@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences King George Medical University, Lucknow 226003  
 
Primary Sponsor  
Name  Dr Akansha Verma 
Address  Department of Conservative Dentistry and Endodontics, Faculty of Dental Sciences K.G. Medical University, Lucknow  
Type of Sponsor  Other [] 
 
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 Akansha Verma  King George Medical University, Faculty of Dental Sciences  Department of Conservative Dentistry and Endodontics
Lucknow
UTTAR PRADESH 
9717877391

akansha291@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional root canal irrigation  irrigation with 3% NaOCl and 17% EDTA 
Intervention  root canal irrigation  1.Ulrasonic irrigation 2.Laser activated irrigation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients who will be willing to participate in study with a informed signed consent.
2.Tooth indicated for root canal treatment.
3.Patients with chronic apical peridontitis with PAI score 4-5
4. Chronic apical periodontitis is generally a non-painful condition in which the apical portion (i.e. the part around the tip) of a tooth’s root is chronically inflamed. The term chronic means the condition has been present for a significant length of time (at least several weeks, and sometimes much longer). There may be drainage through the gums from around the tooth’s root. Drainage into a major nerve canal can lead to numbness, which is generally temporary and resolves following successful treatment of the condition.

 
 
ExclusionCriteria 
Details  1. Previously attempted pulpotomy or pulpectomy
2. Immunocompromised patient (ie, AIDS, Hepatitis B, Hepatitis C, Tuberculosis, Cancer patients).
3. Tooth with a mobility score >2.
4. Tooth with periodontal pocket depth >6mm.
5. Tooth with incompletely formed root apices.
6. Tooth with vertical or horizontal fracture extending  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be bony healing of the periapical area which will be evaluated after 6 months and 12 months postoperatively with CBCT  The primary outcome will be bony healing of the periapical area which will be evaluated after 6 months and 12 months postoperatively with CBCT 
 
Secondary Outcome  
Outcome  TimePoints 
Resolution of preoperative subjective and objective symptoms like pain, swelling , discharge.  1 week 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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)   01/02/2017 
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)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   the study is a randomized, parallel group, multiple arm trial comparing the efficacy of ultrasonic irrigation and laser activated irrigation in endodontic treatment in patients with Chronic apical periodontitis. the study will be conducted in the department of Conservative Dentistry and Endodontics, King George Medical University , FODS, Lucknow.The primary outcome will be healing of bony radiolucency in periapical area which will be evaluated after 6 months and 12 months post operatively with CBCT.  
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