| CTRI Number |
CTRI/2025/11/097786 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Low-Level Laser Therapy vs Intracanal Cryotherapy: Managing Pain After Single Visit Root Canal Treatment in Lower Molars |
|
Scientific Title of Study
|
Comparing the Effect of Low Level Laser Therapy and Intracanal Cryotherapy on Post Operative Pain following Single-Visit Nonsurgical Endodontic Treatment of Mandibular Molars with Irreversible Pulpitis and Apical Periodontitis a Randomized Clinical 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 |
Manali Jagtap |
| Designation |
PG Student |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Manubhai Patel Dental College and Hospital,
Department of Conservative Dentistry, Aesthetics and Endodontics
Vadodara GUJARAT 390011 India |
| Phone |
09099778622 |
| Fax |
|
| Email |
jagtapmanali1999@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Ankit Arora |
| Designation |
Professor |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Manubhai Patel Dental College and Hospital,
Department of Conservative Dentistry, Aesthetics and Endodontics
Vadodara GUJARAT 390011 India |
| Phone |
9033975629 |
| Fax |
|
| Email |
aroraankit24@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Manali Jagtap |
| Designation |
PG Student |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Manubhai Patel Dental College and Hospital,
Department of Conservative Dentistry, Aesthetics and Endodontics
Vadodara GUJARAT 390011 India |
| Phone |
09099778622 |
| Fax |
|
| Email |
jagtapmanali1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manali Jagtap |
| Address |
Manubhai Patel Dental College and Hospital, Department of Conservative Dentistry, Aesthetics and Endodontics |
| 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 |
| Manali Jagtap |
Manubhai Patel Dental college and Hospital |
Department of Conservative Dentistry and Endodontics, Manubhai Patel Dental College and Hospital, Vishwajyoti Ashram, Near Vidyakunj School, Muj Mahuda, Vadodara, Gujarat 390011 Vadodara GUJARAT |
09099778622
jagtapmanali1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group (No Intervention Group) |
2) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis without any adjunct therapy |
| Intervention |
Intracanal Cryotherapy |
2) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis in conjunction with Intracanal Cryotherapy |
| Intervention |
Low Level Laser Therpay |
1) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis in conjunction with Low-level Laser Therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients requiring root canal treatment of mandibular 1st and 2nd molars
2. Patients diagnosed with irreversible pulpitis and or apical periodontitis
3. Teeth with spontaneous pain or lingered by cold or heat
4. Teeth with mature apex
5. Teeth with mobility less than 1mm in either direction
6. PAI Index score of 2 or 3
7. Pre operative tooth and percussion pain of less than 56 mm on a 170 mm visual analogue scale
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients (history of pregnancy, malignancy, diabetes mellitus)
2. Patients with other pulpal diagnosis
3. Patients with a history of analgesic intake (antibiotics, NSAIDs, opioids or corticosteroids) during 12 hours prior to treatment
4. Presence of complex anatomy of the root (severe curvature more than 25 degrees)
5. Calcified or obstructed canals on radiographs
6. Very long roots
7. Internal or External root resorption
8. Teeth with open apex
9. Teeth with procedural errors
10. Presence of any defect in the root such as caries, restoration, previously endodontically treated, root resorption, craze lines and fracture
11. Severely damaged teeth
12. Teeth with severe periodontal disease
13. Teeth with periodontal probing depth more than 3 mm
14. Teeth associated with swelling, sinus tract, presence of a radiographic lesion
15. Tooth hypersensitivity to percussion
16. Absence of occlusal contact
17. Absence of palpation sensitivity |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis in conjunction with Low-level Laser Therapy.
2) To evaluate the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis in conjunction with Intracanal Cryotherapy
|
Baseline T0
6 hours T1
12 hours T2
24 hours T3
48 hours T4
72 hours T5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3) To compare and evaluate the reduction in the degree of post-operative pain following single-visit root canal treatment of mandibular molars with irreversible pulpitis and/or apical periodontitis between Low-level Laser Therapy and Intracanal Cryotherapy |
Baseline T0
6 hours T1
12 hours T2
24 hours T3
48 hours T4
72 hours T5 |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is an in vivo experimental, prospective, double blinded randomized
controlled trial. Participants
in each group will be allocated by Lottery system. The candidate under
supervision will be responsible for providing allocation and division of
patients into three groups and save the data until the date of performing the
procedure. Group 1 Single-visit root canal treatment followed by
Low-level Laser Therapy, Group 2 Single-visit root canal treatment with
adjunctive Intracanal Cryotherapy, Group
3 Single-visit root canal treatment followed by neither of the
adjunctive modalities (Control group). The
outcome assessors and the participants will be blind (double blinded) to the
procedure while the operator (the researcher) will not be blinded owing to the
difference in the modalities employed for the treatment and variations in the
steps involved while performing the procedure. Detailed history would be
recorded and subjective and objective assessment of teeth requiring endodontic
treatment will be done using 170 mm Heft Parker Visual Analogue Scale. The
patient will be explained about the treatment, the alternative treatment and
the risks involved and an informed consent will be given to the patient which
will be signed by the patient giving the consent. Only the patients giving
their consent for the clinical trial will be included in the study and will
randomly be divided into three groups (the three groups will be standardized in
terms of age, gender, type of tooth, root curvature and severity of pain before
treatment) by Lottery method and be scheduled for single-visit root
canal treatment. The procedure will be started with administration of local
anaesthesia. After achieving adequate anaesthesia, rubber dam isolation will be
performed and an access cavity will be prepared using a round bur and
high-speed hand-piece under water and air spray. Class 2 cavities will be
converted into Class 1 cavities by doing Pre-endodontic build-up. After
performing patency filing, the working length of the canals will be determined
using Root ZX apex locator (J Morita), which will be confirmed by digital
radiography. The root canals will be prepared using Rotary System as per apical
constriction and initial binding file and biomechanical preparation will be
completed using crown-down method. Standard Irrigation protocol will be
followed for all the groups. A final rinse will be performed with saline at
room temperature. (Saline at a temperature of 2.5 degree Celsius will be used
as a final irrigant in Intracanal Cryotherapy group). The root canals will be
dried with sterile paper points and filled with gutta-percha and Bioceramic
root canal sealer (Bioactive Root Canal Sealer, Safe Endo) with warm vertical
compaction technique (Orikam Fast pack and Fast fill devices) in the same
session; the quality of obturation would be checked by taking final Intaoral
Periapical Radiographs. The teeth will
be disoccluded and post endodontic restoration will be completed. After
the completion of single-visit endodontic procedure following the above
mentioned protocol. The first group will be subject to Low-level Laser Therapy
by laser irradiation performed using 980-nm diode laser (Rise Medicare) 0.5 W
power and a tip diameter of 10 mm for 15 seconds. The laser will be irradiated
to the soft tissues covering the mesial and distal apices of the tooth from
buccal as well as lingual sides for 15 seconds at each site with the tip of the
laser handpiece held at a distance of approximately 10 mm from the mucosa. The
fibre tip of the laser will be positioned perpendicular to the surface and
close to the soft tissue. The study participants will be assessed for the
intensity of pain experienced at 6, 12, 24, 48 and 72 hours postoperatively
using a Heft-Parkar visual analogue scale (VAS) and a patient questionnaire
which will include the duration to which pain lasted, the number of medications
patient had required to take to relieve pain or any other complains related to
the tooth, wherein telephonic evaluation of postoperative pain will be done by
contacting through phone on specific hours and days and a second appointment
will be scheduled for follow-up visit 72 hours post-operatively; when the
patient will be assessed clinically to check for intra-oral complications and
percussion test will be done to check the periapical status.
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