| CTRI Number |
CTRI/2021/05/033802 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
18/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF PAIN AFTER ROOT CANAL TREATMENT WITH TWO DIFFERENT TECHNIQUES FOLLOWED BY USING LASERS FOR DISINFECTION OF ROOT CANALS |
|
Scientific Title of Study
|
COMPARISON OF POST-OPERATIVE PAIN USING TWO INSTRUMENTATION TECHNIQUES FOLLOWED BY LASER IRRADIATION IN NON-VITAL TEETH WITH SYMPTOMATIC APICAL PERIODONTITIS: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreya Shivangi |
| Designation |
PG STUDENT |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi MumbaI |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614
Mumbai MAHARASHTRA 400614 India |
| Phone |
8310270967 |
| Fax |
|
| Email |
shivangi.shreya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashish Jain |
| Designation |
Head of Department |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614
Mumbai MAHARASHTRA 400614 India |
| Phone |
9869152905 |
| Fax |
|
| Email |
drakjain5@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shreya Shivangi |
| Designation |
PG STUDENT |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614
Mumbai MAHARASHTRA 400614 India |
| Phone |
8310270967 |
| Fax |
|
| Email |
shivangi.shreya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Dr Shreya Shivangi |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Shivangi |
| Address |
Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shreya Shivangi |
Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai |
Room no 302, 3rd floor Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614
Mumbai
MAHARASHTRA Mumbai MAHARASHTRA |
8310270967
shivangi.shreya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Symptomatic Apical periodontitis |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laser therapy along with continuous rotary instrumentation |
Biomechanical preparation will be done using Pro HS niti rotary files following which Biolase EpicX laser (940nm wavelength, 50/60 Hz frequency in pulsed mode) with attached laser tip of 200µm diameter will be placed in the root canal 2mm short of apex. An irradiation of 5 sec followed by a 10 sec pause will be performed 4 times. |
| Intervention |
Laser therapy along with engine driven reciprocating handpiece instrumentation. |
K-Flex files will be used for biomechanical preparation using k-400 reciprocating handpiece following which Biolase EpicX laser (940nm wavelength, 50/60 Hz frequency in pulsed mode) with attached laser tip of 200µm diameter will be placed in the root canal 2mm short of apex. An irradiation of 5 sec followed by a 10 sec pause will be performed 4 times. |
| Comparator Agent |
Nil |
N.A. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects older than 18 years of either gender.
Subjects having a single rooted non-vital tooth with symptomatic apical periodontitis needing primary endodontic treatment.
Cooperative health subjects who are willing to participate in the study and sign the consent form |
|
| ExclusionCriteria |
| Details |
-Subjects with uncontrolled systemic diseases or allergies.
-History of previous root canal treatment.
-Presence of swelling or sinus tracts.
-Presence of severe periodontal disease.
-Periapical radiolucency.
-Subjects who’ve taken analgesics within the last 3 days.
-Subjects allergic to local anesthesia.
-Subjects unwilling to sign the consent form |
|
|
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 |
| Post operative pain scores |
Baseline, 24 hrs, 48 hrs and 72 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percussion pain scores |
Pre-operative percussion pain score and post - operative percussion pain score (at 72 hours) |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2021 |
| Date of Study Completion (India) |
29/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain management is one of the most
important aspects of endodontic treatment. Infected root canals are the most
common cause of endodontic pain. Apical extrusion of debris is a drawback
of all endodontic instrumentation techniques. This can result in post-operative
pain and discomfort due to inflammation of periapical tissues. It is generally accepted that crown down
technique and balanced force technique cause less apical extrusion of debris
and hence lesser post-operative pain. In earlier studies related to lasers, the
use of lasers was limited to treating dentinal hypersensitivity, for its
effects on vital pulpotomy, and for evaluating postoperative pain and swelling
in patient undergoing extractions of impacted 3rd molar. Use of lasers after chemo-mechanical
preparation have been shown in some studies to affect pain outcomes favourably.
However, the crown down technique for NiTi
has several drawbacks such as file breakage, poor dentin conservation
(predisposing to vertical root fractures) and high recurring cost. According to our literature search, post-operative
pain due to debris extrusion with k400 reciprocating handpiece for hand files
using step back technique has never been compared with NiTi rotary
instrumentation using crown down technique. Also, to the best of our knowledge,
Biolase EpicX, K400 Reciprocation Handpiece, and Pro HS Niti Rotary systems
have not been used in the investigations for the same. Therefore, this clinical study proposes to
investigate the incidence of post-operative pain following chemo-mechanical
preparation of single rooted teeth having symptomatic apical periodontitis using
rotary instrumentation with Pro HS file system and engine driven reciprocating
instrumentation with K-flex files along with laser irradiation (by Biolase
EpicX). |