| CTRI Number |
CTRI/2024/07/070538 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
low level laser therapy(photo biomodulation) may decrease the pain after root canal treatment in patients with pulpitis |
|
Scientific Title of Study
|
Effect of modified Photo Biomodulation protocols on post operative endodontic pain following single visit endodontics in patients with symptomatic irreversible pulpitis. |
| 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 KEERTHY P K |
| Designation |
Post graduate student |
| Affiliation |
Malabar dental college and research centre, Edappal,Malappuram, Kerala |
| Address |
Post graduate student,Dept.of Conservative Dentistry and Endodontics,Malabar dental college and research centre, Edappal,Malappuram, Kerala
Malappuram
KERALA
679578
India |
| Phone |
8129097898 |
| Fax |
|
| Email |
keerthypk1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu Hariharan MDS |
| Designation |
Professor |
| Affiliation |
Malabar dental college and research centre, Edappal,Malappuram, Kerala |
| Address |
Professor,Dept.of Conservative Dentistry and Endodontics,Malabar dental college and research centre, Edappal,Malappuram, Kerala
Malappuram
KERALA
679578
India |
| Phone |
9995296770 |
| Fax |
|
| Email |
hariharanmadhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu Hariharan MDS |
| Designation |
Professor |
| Affiliation |
Malabar dental college and research centre, Edappal,Malappuram, Kerala |
| Address |
Professor,Dept.of Conservative Dentistry and Endodontics,Malabar dental college and research centre, Edappal,Malappuram, Kerala
Malappuram
KERALA
679578
India |
| Phone |
9995296770 |
| Fax |
|
| Email |
hariharanmadhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malabar dental college and research centre Edappal, Malappuram, Kerala ,India PIN : 679578 |
|
|
Primary Sponsor
|
| Name |
Dr KEERTHY P K |
| Address |
Post graduate student,Department of Conservative Dentistry and Endodontics, Malabar dental college and research centre , Edappal, Malappuram, Kerala |
| 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 MADHU HARIHARAN |
Malabar dental college and research centre |
Dept of Conservative dentistry and Endodontics,Malabar dental college and research centre, Manoor,Edappal,Malappuram,Kerala,India PIN:679578
Malappuram
KERALA |
9995296770
hariharanmadhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE OF MALABAR DENTAL COLLEGE AND RESEARCH CENTRE |
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 |
laser is placed but not activated |
| Intervention |
Laser irradiation is done with 810nm laser post root canal treatment |
with a dosage of 8J
energy i.e, 0.2W for 4sec at the root apices of endodontically treated tooth. |
| Intervention |
Laser irradiation is done with 810nm laser pre & post root canal treatment |
with a dosage of
4J energy in each session i.e, 0.2W for 2sec in each session at the apices of the tooth of interest |
| Intervention |
Laser irradiation is done with 940 nm laser post root canal treatment |
with a dosage of 8J
energy i.e, 0.2W for 4sec at the root apices of endodontically treated tooth. |
| Intervention |
Laser irradiation is done with 940nm laser pre & post root canal treatment |
with a dosage of
4J energy in each session i.e, 0.2W for 2sec in each session at the apices of the tooth of interest |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for root canal treatment for symptomatic irreversible pulpitis on first or second mandibular molars are included
Patients scheduled for root canal treatment for symptomatic irreversible pulpitis on first or second mandibular molars are included |
|
| ExclusionCriteria |
| Details |
Patients are not included into the study if one of the following criteria applied: severe general disease (ASA classes 3 and 4), pregnancy, known allergies to local anaesthetics , and NSAIDs, acute apical periodontitis , recent history of chronic pain medication
Patients are excluded in case of periodontal probing greater than 3 mm, swelling or sinus tract and tenderness on palpation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pre and post operative pain score on non graded VAS scale between 0 to 10 |
4h,8h,12h,24h and 48h after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| post operative pain score on non graded VAS scale between 0 to 10 |
7 days after treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2024 |
| 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="8"
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
|
60 patients requiring endodontic treatments in vital mandibular molar teeth with symptomatic irreversible pulpitis are selected . The patients’ demographic data including age, gender and tooth number are recorded. Patients are provided with a non-numeral 10cm VAS to record their tooth pain. Their preoperative pain values are recorded. A single visit endodontic treatment is advised. The root canal procedures are performed by following a standardized protocol. A final radiograph is taken to confirm the quality of the root filling. Then the patients are randomly allocated for real or sham laser irradiation. Low level laser is irradiated to the buccal mucosa overlying the apices of the target tooth in the study groups. In the sham group patients received placebo laser to eliminate the probable psychological effects of laser. After laser/sham treatment, each patient is given a home questionnaire and a second appointment is scheduled for permanent tooth restoration one week later. Each patient is given 10 tablets of 500 mg acetaminophen and are instructed to take them in case of pain. The patients are instructed to record their postoperative pain levels at 4, 8, 12 ,24 and 48h after treatment on separate VAS scales. The patients are contacted by phone on specific hours to remind them to record their pain level. They are also asked to record consumption of analgesic on the questionnaire (dosage and exact time of taking the analgesic).Patients are free to ask for an unscheduled appointment, if needed, which will also be recorded. At the second visit scheduled 1 week later, the patients are asked to return the questionnaires, and their chair side level of pain on palpation and percussion are also recorded on VAS scale. GROUP 1 :Laser irradiation is done with 940 nm laser post treatment with a dosage of 8J energy. GROUP 2 :Laser irradiation is done with 810nm laser post treatment with a dosage of 8J energy. GROUP 3 :Laser irradiation is done with 940nm laser pre & post treatment with a dosage of 4J energy each. GROUP 4 : Laser irradiation is done with 810nm laser pre & post treatment with a dosage of 4J energy each. GROUP 5: is the sham group where laser is placed but not activated EXPECTED OUTCOME- There will be a difference in reduction of post operative endodontic pain intensity following irradiation using 940nm and 810nm lasers and their modified protocols |