| CTRI Number |
CTRI/2024/11/077228 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect LASER light and painkiller on pain after root
canal treatment |
|
Scientific Title of Study
|
A Comparative Evaluation of The Effect of Low-Level LASER
Therapy, LASER-Activated Irrigation and Preoperative
Aceclofenac on Post Endodontic Pain After Single Visit Root
Canal Treatment - A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Wasule |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
117,department of conservative dentistry and
endodontics,govt dental college and hospital,medical square,medical
chowk nagpur,maharastra,india
Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
08275225852 |
| Fax |
|
| Email |
aditi.wasule13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshan Dakshindas |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
117,department of conservative dentistry and
endodontics,govt dental college and hospital,medical square,medical
chowk nagpur,maharastra,india
Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9823286490 |
| Fax |
|
| Email |
ddakshindas22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshan Dakshindas |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital, Nagpur |
| Address |
117,department of conservative dentistry and
endodontics,govt dental college and hospital,medical square,medical
chowk nagpur,maharastra,india
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9823286490 |
| Fax |
|
| Email |
ddakshindas22@gmail.com |
|
|
Source of Monetary or Material Support
|
| government dental college and hospital, medical square,medical
chowk,nagpur,maharastra,4400003 |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Wasule |
| Address |
Department of Conservative Dentistry and Endodontics,Government Dental College and Hospital, Nagpur |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Aditi wasule |
Government Dental college and hospital , Nagpur |
Room 117, Department of conservative dentistry and endodontics, Government dental college and hospital
Nagpur
MAHARASHTRA |
08275225852
aditi.wasule13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional ethics committee,government dental college and hospital,nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Patients receiving preoperative placebo tablet and mock laser. |
| Intervention |
laser activated irrigation |
Patients receiving preoperative placebo tablet and laser
activated irrigation. |
| Intervention |
low level laser therapy |
Patients receiving preoperative placebo tablet and low-level
laser therapy. |
| Intervention |
preoperative Aceclofenac controlled release tablet |
Patients receiving preoperative Aceclofenac controlled release
(200mg) 1 hour before procedure and mock LASER. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy patients aged between 18-40 years.
2. Permanent mandibular premolars with complete root
formation.
3. Permanent mandibular premolars with diagnosis of
symptomatic irreversible pulpitis with symptomatic
apical periodontitis.
4. Permanent mandibular premolars indicated for
primary root canal treatment with Periapical Index
Score (PAI) of 1 or 2. |
|
| ExclusionCriteria |
| Details |
1. Patients who are medically compromised.
2. Patients who had taken antibiotics in last 1 month and
non-steroidal anti-inflammatory drugs 24 hours prior
to procedure.
3. Patients contraindicated for Aceclofenac, Lignocaine,
use of apex locator and patients allergic to latex.
4. Pregnant and lactating women.
5. Adjacent carious teeth.
6. Immature teeth or teeth with root resorption.
7. Teeth with calcified canals.
8. Teeth with sinus opening or periapical radiolucency
with PAI score of 3 or higher. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post operative pain |
6hrs, 24hrs, 48hrs, 72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no. of analgesics taken |
6hrs, 24hrs, 42hrs, 72hrs |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 3 |
|
Date of First Enrollment (India)
|
03/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain after endodontic treatment is a common side effect with
significant effect on the quality of life of the patients. Pretreatment analgesia is providing analgesia to patients before
endodontic treatment is started. This technique can decrease
the establishment of central and peripheral sensitization, which
has the potential to reduce postoperative pain and
postoperative analgesic intake. The controlled-release formulation of Aceclofenac
allows the drug to be effective over an extended period. It also
reduces repeated administration of the drug and allows for
better patient compliance. Laser-activated irrigation (LAI) generates optical
cavitation in the irrigant, causing the formation of vapor
bubbles. LAI is very effective in debris removal from canal
complexities which occurs exceedingly fast, causing a very rapid
turbulence in the liquid throughout the whole canal. Moreover,
LAI showed reduced postoperative pain and discomfort
following endodontic treatment in single visit which was
attributed to the technique’s low intra-canal pressure, which
does not exceed the pressure in the apical tissues or the
5.88 mmHg central venous pressure. Low-level LASER therapy (LLLT) increases endogenous endorphins (β-endorphin) and
decreases the activity of C-fibers and bradykinin, and thus
creates an analgesic effect. LLLT application also increases
phagocytic activity, number and diameter of lymphatic vessels,
decreases the permeability of blood vessels, thus reducing
edema and post-operative symptoms. This treatment is
nowadays called “photobiomodulationâ€, also referred to as
“LLLT†in literature. Thus, this study compares the various modalities for pain
reduction like low-level LASER Therapy, LASER-activated
irrigation and administration of preoperative Aceclofenac.
|