| CTRI Number |
CTRI/2025/05/086766 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare the effect of diode laser and photoactivated disinfection on postoperative pain and periapical healing following root canal treatment – A Randomized Controlled Clinical Trial.. |
|
Scientific Title of Study
|
Comparative evaluation of Diode laser and Photoactivated disinfection on endodontic treatment outcome – A Randomized Controlled 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 |
Samiya Kulsoom |
| Designation |
Junior Resident |
| Affiliation |
Dr. Ziauddin Ahmad Dental College, AMU |
| Address |
Department of Conservative Dentistry and Endodontics, Dr. Ziauddin Ahmad Dental College, Medical road, AMU
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7701903485 |
| Fax |
|
| Email |
samiyakulsoom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Ashok Kumar |
| Designation |
Professor |
| Affiliation |
Dr. Ziauddin Ahmad Dental College, AMU |
| Address |
Department of Conservative Dentistry and Endodontics, Dr. Ziauddin Ahmad Dental College, Medical road, AMU
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9412732327 |
| Fax |
|
| Email |
ashokoperative@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Samiya Kulsoom |
| Designation |
Junior Resident |
| Affiliation |
Dr. Ziauddin Ahmad Dental College, AMU |
| Address |
Department of Conservative Dentistry and Endodontics, Dr. Ziauddin Ahmad Dental College, Medical road, AMU
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7701903485 |
| Fax |
|
| Email |
samiyakulsoom@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ziauddin Ahmad Dental College, Medical road, Aligarh Muslim University, Aligarh, Uttar Pradesh-202001, India |
|
|
Primary Sponsor
|
| Name |
Samiya Kulsoom |
| Address |
Department of Conservative Dentistry and Endodontics, Dr. Ziauddin Ahmad Dental College, Medical road, Aligarh Muslim University, Aligarh, Uttar Pradesh-202001, India |
| 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 Samiya Kulsoom |
Dr. Ziauddin Ahmad Dental College, AMU |
Department of Conservative Dentistry and Endodontics, OPD NO. 7, Dr. Ziauddin Ahmad Dental College, Medical road, AMU, Aligarh, Uttar Pradesh-202001,India
Aligarh
UTTAR PRADESH |
7701903485
samiyakulsoom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode Laser |
Diode Laser will be use for root canal disinfection.
Frequency: Each canal will be irradiated twice.
Duration: The duration of irradiation per canal is determined by the working length (WL). Its 2 seconds per millimeter of WL, and this is performed for each of the two irradiations. There is also a 30-second interval between the two irradiations in each canal. |
| Comparator Agent |
Photoactivated Disinfection (PAD) |
Photoactivated Disinfection will be use for root canal disinfection.
Frequency: The PAD treatment is performed once per canal.
Duration:
The PAD solution is left in the canal for a contact period of 5 minutes.
The solution is agitated with a file for 60 seconds.
The emitter tip is activated for 180 seconds in endodontic mode. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients must agree to participate, single rooted teeth with pulp necrosis and symptomatic apical periodontitis, Radiographic evidence of periapical radiolucency with PAI score more than or equal to three |
|
| ExclusionCriteria |
| Details |
Teeth with immature roots.
Calcified canals.
Poor restorative, or periodontal prognosis.
Antibiotic use within the last month.
Anti-inflammatory analgesic use within the last 5 days.
Patients with any uncontrolled systemic disease.
Pregnant or Lactating females.
|
|
|
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 |
4, 24, 48, and 72-hour postoperative intervals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Periapical healing |
3, 6 and 12 months after root canal treatment. |
|
|
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)
|
01/06/2025 |
| 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
|
The effectiveness of endodontic treatment largely depends on the removal of bacteria and irritants from the root canal prior to obturation. Chemical debridement aids in the elimination of residual tissue and bacterial biofilm, particularly from the non-instrumented region of the root canal system. In recent year, intracanal laser has emerged as an adjunctive treatment for endodontic procedure. The aim of this randomized controlled trial is to evaluate the difference in postoperative pain and periapical healing following root canal treatment with diode laser and photoactivated disinfection used for root canal irrigation. The null hypothesis is that there is no significant difference in postoperative pain and periapical healing between the two treatment methods. |