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
|
|
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
|
|
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. |