| CTRI Number |
CTRI/2025/12/099956 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF LASER ASSISTED ARTICAINE LOCAL ANESTHESIA IN SINGLE VISIT ROOT CANAL TREATMENT FOR MANDIBULAR MOLAR WITH SYMPTOMATIC IRREVERSIBLE PULPITIS A RANDOMISED CLINICAL TRIAL. |
|
Scientific Title of Study
|
EFFECT OF LASER ASSISTED ARTICAINE LOCAL ANESTHESIA IN SINGLE-VISIT ROOT CANAL TREATMENT FOR MANDIBULAR MOLAR WITH SYMPTOMATIC IRREVERSIBLE PULPITIS: 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 |
JENCY ABARNA S |
| Designation |
POST GRADUATE |
| Affiliation |
INDIRA GANDHI ISTITUTE OF DENTAL SCIENCE |
| Address |
Department of conservative dentistry and endodontics, NO.3,INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE , PILLAYARKUPPAM., Pondicherry.
Department of conservative dentistry and endodontics, NO.3,INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE , PILLAYARKUPPAM., Pondicherry.
Pondicherry
PONDICHERRY
621601
India |
| Phone |
9788031310 |
| Fax |
|
| Email |
sylviajency@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Dhanavel C |
| Designation |
Head of the department |
| Affiliation |
INDIRA GANDHI ISNTITUTE OF DENTAL SCIENCE |
| Address |
Department of conservative dentistry and endodontics, NO.3,INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE , PILLAYARKUPPAM., Pondicherry.
Department of conservative dentistry and endodontics, NO.3,INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE, PILLAYARKUPPAM., Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9944717497 |
| Fax |
|
| Email |
drdhanavelods@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Dhanavel C |
| Designation |
Head of the department |
| Affiliation |
INDIRA GANDHI ISNTITUTE OF DENTAL SCIENCE |
| Address |
Department of conservative dentistry and endodontics, NO.3,INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE, PILLAYARKUPPAM, Pondicherry.
Department of conservative dentistry and endodontics, NO.3, INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE, PILLAYARKUPPAM, Pondicherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9944717497 |
| Fax |
|
| Email |
drdhanavelods@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of conservative dentistry and endodontics, INDIRA GANDHI INSTITUTE OF DENTAL SCIENCE, PUDUCHERRY. |
|
|
Primary Sponsor
|
| Name |
Dr JENCY ABARNA S |
| Address |
66/ A Antony Samy Illam
TV Nagar,
Lalgudi.
Pincode-621601 |
| Type of Sponsor |
Other [self funding ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Investigator JENCY ABARNA S |
66/ A antony samy illam tv nagar , lalgudi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JENCY ABARNA S |
Indira gandhi institute of dental sciences |
NO.23-Department of conservative dentistry and endodontics ,ECR ROAD,PILLAYKUPPAM
607402
Pondicherry
PONDICHERRY |
09788031310
sylviajency@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
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 |
| Intervention |
1.980 nm diode laser Irradiation
2.suppplemental anaesthsia with 4% articaine |
group 14% articaine, followed by adjunctive 980 nm diode laser irradiation group 2 supplemental 0.2 ml intraligamentary and 0.9 ml buccal infiltration anesthesia without laser application |
| Comparator Agent |
IANB with 980nm Diode laser |
Group 1 (Laser Group): Patients received Inferior Alveolar Nerve Block (IANB) using 4% articaine with 1:100,000 epinephrine. Additionally, a 980 nm diode laser (INDILASER) was applied directly to the pulp chamber and within the root canals. Laser settings were 1.5 watts power, continuous mode, applied for 60 to 180 seconds per canal. Root canal treatment was initiated immediately after laser application.
Group 2 (Control Group): Patients received standard IANB with articaine and epinephrine, followed by supplemental 0.2 ml intraligamentary and 0.9 ml buccal infiltration anesthesia without laser application. Root canal treatment was then performed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with normal general health willing to participate in this study
2 Patients aged 18-45 yrs
3 Mandibular molars with symptoms of irreversible pulpitis
4 Case that is ideal to perform single visit root canal technique.
5 Moderate to severe pain
6 Lingering response to cold pulp sensibility test
|
|
| ExclusionCriteria |
| Details |
1 Patients with systemic diseases or condition that hindering single visit root canal treatment.
2 Pregnant patients or nursing mothers.
3 Allergic to local anaesthesia.
4 Presence of any periapical radiolucency on radiographs.
5 Pain symptoms not indicative of irreversible pulpitis or no pain
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of intraoperative pain control between diode laser group and articaine injection group during single visit root canal treatment of mandibular molar with sympromatic irreversible pupitis. |
Comparison of intraoperative pain control between diode laser group and articaine injection group during single visit root canal treatment of mandibular molar with sympromatic irreversible pupitis. it does not include weeks or months as it is single visit RCT, the time line is mostly baseline and post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the intraoperative pain scores measured during the root canal procedure using the Visual Analog Scale (VAS) & the recording of physiological parameters such as pulse rate. These measures supplement the primary outcome of anesthetic success by assessing patient comfort & systemic response during treatment. The study compares the effectiveness of 980 nm diode laser adjunct anesthesia versus conventional anesthesia methods in reducing pain intensity & physiological stress during endodontic therapy for symptomatic irreversible pulpitis within around 3 months of time in the upcoming year |
The secondary outcome (intraoperative pain & pulse rate) was recorded continuously during root canal treatment & immediately post-operatively, within 3 months of time period |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 |
|
Date of First Enrollment (India)
|
14/01/2026 |
| 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="3"
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 study is a double-blind randomized controlled clinical trial conducted at the Department of Conservative Dentistry and Endodontics, IGIDS, SBV Puducherry, to compare the anesthetic efficacy of inferior alveolar nerve block (IANB) using 4% articaine with 1:100,000 epinephrine versus adjunctive 980 nm diode laser irradiation in patients with symptomatic irreversible pulpitis of mandibular molars undergoing single-visit root canal treatment. Sixty-four patients aged 18–45 years with moderate to severe pain were randomized into two groups. Outcomes assessed included pulpal anesthesia success using the Visual Analog Scale (VAS), intraoperative pain intensity, and physiological parameters. The trial aims to determine whether laser-assisted anesthesia enhances pain control and anesthesia efficacy in challenging inflamed pulpal tissue scenarios, ensuring safer and more effective endodontic management. |