| CTRI Number |
CTRI/2025/09/095172 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate reduction in post operative pain after single visit root canal treatment in non vital teeth after using Er:YaG laser therapy |
|
Scientific Title of Study
|
Randomised control study to evaluate incidence of post operative pain following single visit endodontics in non vital teeth using Er:YaG laser |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NEHA PRASHAR |
| Designation |
DENTAL OFFICER |
| Affiliation |
MINISTRY OF DEFENCE |
| Address |
SURGERY NO 4 (CONSERVATIVE DENTISTRY AND ENDODONTICS )
MILITARY DENTAL CENTRE (GL)
GOUGH LINES
SECUNDERABAD
Hyderabad TELANGANA 500015 India |
| Phone |
9765271410 |
| Fax |
|
| Email |
drdentistneha@outlook.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr NEHA PRASHAR |
| Designation |
DENTAL OFFICER |
| Affiliation |
MINISTRY OF DEFENCE |
| Address |
SURGERY NO 4 (CONSERVATIVE DENTISTRY AND ENDODONTICS )
MILITARY DENTAL CENTRE (GL)
GOUGH LINES
SECUNDERABAD
Hyderabad TELANGANA 500015 India |
| Phone |
9765271410 |
| Fax |
|
| Email |
drdentistneha@outlook.com |
|
Details of Contact Person Public Query
|
| Name |
Dr NEHA PRASHAR |
| Designation |
DENTAL OFFICER |
| Affiliation |
MINISTRY OF DEFENCE |
| Address |
SURGERY NO 4 (CONSERVATIVE DENTISTRY AND ENDODONTICS )
MILITARY DENTAL CENTRE (GL)
GOUGH LINES
SECUNDERABAD
Hyderabad TELANGANA 500015 India |
| Phone |
9765271410 |
| Fax |
|
| Email |
drdentistneha@outlook.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ministry of Defence OO DGDS |
| Address |
Military Dental Centre (GL)
Gough Lines,
Secunderabad , Telangana, India
Pin 500015
|
| Type of Sponsor |
Government funding agency |
|
|
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 Neha Prashar |
Military Dental Centre (GL) Secunderabad |
Surgery No 4 ( Conservative Dentistry & Endodontics)
Military dental Centre (GL)
Gough Lines ,
Secunderabad Pin -500015 Hyderabad TELANGANA |
9765271410
drdentistneha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army College of Dental Sciences Institiutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional syringe Irrigation |
Use of conventional syringe irrigation or manual irrigation with saline /sodium hypochlorite solution to flush debris and disrupt microbial biofilm in root canals . |
| Intervention |
Er:YaG laser activated irrigation |
Use of Er:YaG laser to disrupt microbial biofilm & canal disinfection through acoustic streaming & cavitation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Multirooted tooth with a diagnosis of pulp necrosis, showing apical periodontitis (1mm-2mm) as confirmed by radiovisiography
2.No spontaneous pain
3.No contributory medical history
|
|
| ExclusionCriteria |
| Details |
- Medically compromised patient
-Teeth with pus discharge
-Anatomic variations
-Patients not on analgesics or sedative medication prior to
root canal therapy
-Teeth without sinus tract
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Er: YaG is an effective method for disinfection to provide painless single sitting RC in a non vital multirooted tooth . |
The patient will be evaluated at 12 hrs, 48 hrs and 72 hrs post treatment for pain assessment using VAS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
| Historically, Rootcanal treatment reminds of painful long multiple sitting. With advances in research and technology single visit endodontics has gained acceptance. Success of root canal treatment depends on proper cleaning , shaping & disinfecting the canals& hermetically sealing the canals. Very few studies have been carried out to compare the effectiveness of Er:YaG laser in single sitting endodontic treatment for non-vital tooth. In our fast pacing & committed life, Successful Single visit endodontics is the treatment of choice. However , painless procedure followed by predictable treatment outcome is still a challenge. Aim of the study is to find the Incidence of post-operative pain following single visit endodontics in non-vital teeth , using Er:YAG laser i) To compare treatment outcome of single visit endodontics in non vital teeth against the conventional treatment and study pattern of pain post operative after 1st day ,3rd day & 5th day using Visual analogue scale . | | In this prospective clinical study, 60 multirooted teeth indicated for endodontic treatment were treated by a single endodontist according to a preestablished protocol. The teeth were randomly divided into four groups (n = 30). Group 1 – Single sitting endodontics with use of Er: YAG laser & Sodium hypochlorite as last irrigant . Group 2 – Single sitting endodontics with use of conventional syringe for irrigation with sodium hypochlorite as last irrigant . The patients will be allotted in all work groups using block randomization. All the cases will be studied for pattern of pain after 12, 48 and 72 hrs of endodontic treatment, patients’ pain post operatively will be evaluated telephonically through a Visual Analog Scale (VAS) ranging from 0 to 10. Scale 0-6 will be evaluated as mild to moderate pain manageable with & without analgesics. Scale 0-7 will be evaluated as severe pain not manageable by medication, requiring clinical re-evaluation. In all workgroups, similar protocols were used for instrumentation with the Protaper files & strictly adhering to the working length , irrigation with 2.5% sodium hypochlorite, and 6% Gutta Percha for obturation will be used . All treated tooth will be de-occluded post obturation. Informed consent of the patient will be taken prior to the treatment. The data obtained will be analysed statistically for any significant post operative pain in single sitting endodontic treatment in non vital tooth after 12, 48, 72 hrs evaluation and between the group. | |
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