| CTRI Number |
CTRI/2023/01/048830 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of low level laser therapy in older individuals after single visit endodontic treatment. |
|
Scientific Title of Study
|
Efficacy of Low Level Laser Therapy in the Management of Postoperative Pain after Single Visit Endodontic Treatment in patients with Symptomatic Apical Periodontitis: A Single Blinded Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandhita Murugavel |
| Designation |
Post graduation student |
| Affiliation |
KLE Societys Institute of Dental Sciences, Bangalore |
| Address |
Room no.6, Department of Conservative dentistry and Endodontics, KLE Societys Institute of Dental Sciences, No.20, Tumkur road, Yeshwanthpur suburb, Bangalore- 560022
Room no.6, Department of Conservative dentistry and Endodontics, KLE Societys Institute of Dental Sciences, No.20, Tumkur road, Yeshwanthpur suburb, Bangalore- 560022
Bangalore
KARNATAKA
560034
India |
| Phone |
8073054240 |
| Fax |
|
| Email |
nandhita.murugavel@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Karale |
| Designation |
Head of Department, Department of Conservative dentistry and Endodontics |
| Affiliation |
KLE Societys Institute of Dental Sciences, Bangalore |
| Address |
KLE Societys Institute of Dental Sciences, No.20, Tumkur road, Yeshwanthpur suburb, Bangalore
No.20, Tumkur road, Yeshwanthpur suburb, Bangalore- 560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9481488247 |
| Fax |
|
| Email |
drkarale79@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rupali Karale |
| Designation |
Head of Department, Department of Conservative dentistry and Endodontics |
| Affiliation |
KLE Societys Institute of Dental Sciences, Bangalore |
| Address |
KLE Societys Institute of Dental Sciences, No.20, Tumkur road, Yeshwanthpur suburb, Bangalore
No.20, Tumkur road, Yeshwanthpur suburb, Bangalore- 560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9481488247 |
| Fax |
|
| Email |
drkarale79@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, KLE Societys Institute of Dental Sciences, Bangalore |
|
|
Primary Sponsor
|
| Name |
Nandhita Murugavel |
| Address |
A-802, Floriana Estate, 53, Sarjapur main road, Koramangala- 3rd block, Bangalore- 560034 |
| 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 |
| Nandhita Murugavel |
KLE Societys Institute of Dental Sciences, Bangalore |
Room no.6, Department of Conservative dentistry and Endodontics, KLE Societys Institute of Dental Sciences, No.20, Tumkur road, Yeshwanthpur suburb, Bangalore- 560022
Bangalore
KARNATAKA |
8073054240
nandhita.murugavel@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KLE Societys Institute of Dental Sciences, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low Level Laser Therapy |
Diode laser of wavelength 980 nm and output power 200
milliwatts will be activated around the apical region of each root for 35 seconds, 10 mm
from the tissue buccally and lingually.
|
| Comparator Agent |
Placebo application of laser |
The placebo group will receive a sham laser application wherein the laser tip will be
placed adjacent to the tissue, but will not be activated for a duration of 35 seconds from the buccal and lingual aspect of the tooth. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age group of 40-65 years.
2. Permanent mandibular premolars and molars having symptomatic irreversible
pulpitis with symptomatic apical periodontitis
3. Pre-operative pain VAS score: greater than 4.
4. Tenderness on percussion with percussion VAS score: greater than 4
5. Early or lingering response to cold and EPT pulp sensibility testing
6. Patients who will be able to give oral and written informed consent |
|
| ExclusionCriteria |
| Details |
1. Systemic disorders: Cardiovascular system (CVS) disorders, respiratory
disorders, asthma patients, coagulation disorders, thyroid disorders, psychiatric
disorders, immunocompromised patients.
2. Medical drug intake: patients who have taken analgesics, corticosteroids,
sedatives, muscular relaxants, anti-clotting agents or antibiotics 12 hours prior to
the intervention.
3. Pregnant individuals.
4. Radiographically detected large periapical lesions or abscesses, space infections
5. History of previous root canal treatment in the same tooth
6. Periodontally compromised tooth (>grade I mobility, pocket depth >4 mm) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and
postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic
Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older
individuals treated with single visit endodontics followed by interventional application of low level laser therapy
or sham laser application. |
To evaluate the pain Visual Analogue Scale (VAS) scores preoperatively and
postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic
Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older
individuals treated with single visit endodontic treatment followed by interventional application of low level laser therapy
or sham laser application. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pre-operative or baseline percussion VAS scores will also be compared with 7th
day percussion VAS score. |
Day 1 and Day 7 post-endodontic treatement |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
15/01/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, single-blinded, single-center trial evaluating the efficacy of Low Level Laser Therapy in the management of postoperative pain after
Single Visit Endodontic Treatment in symptomatic apical periodontitis cases in an older age group. The primary outcome measures of this study are to record and evaluate the pain Visual Analogue Scale scores preoperatively and
postoperatively on the 1st, 2nd, 3rd, 5th, 7th and 30th day in Symptomatic
Irreversible Pulpitis with Symptomatic Apical Periodontitis cases in older
individuals treated with single visit endodontic treatment followed by interventional application of low level laser therapy or sham laser, which will be the mock application of the laser. |