| CTRI Number |
CTRI/2026/02/103066 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Three Drugs In The Form Of Dental Injections As Intervention To
Reduce Tooth Pain During Root Canal Treatment In Participants With Severe Toothache |
|
Scientific Title of Study
|
Comparative Evaluation Of Efficacy Of Intraligamentary Injection Using Articaine, Ketorolac
And Dexamethasone For Reduction Of Endodontic Pain In Symptomatic Irreversible Pulpitis: A
Randomized Double Blinded Clinical Study |
| 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 SAMALA ANUHYA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Room number 7, Department of
Conservative Dentistry and Endodontics at Kamineni Institute of Dental Sciences, Narketpally,
Nalgonda district, Telangana state, pincode:508254.
NARKETPALLY
Nalgonda
TELANGANA
508254
India |
| Phone |
8309396512 |
| Fax |
|
| Email |
drsamalaanuhya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. S JAYAPRADA REDDY |
| Designation |
MDS, PhD |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Room number 7, Department of
Conservative Dentistry and Endodontics at Kamineni Institute of Dental Sciences, Narketpally,
Nalgonda district, Telangana state, pincode:508254.
Nalgonda
TELANGANA
508254
India |
| Phone |
9703936020 |
| Fax |
|
| Email |
drsjayapradareddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAMALA ANUHYA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Room number 7, Department of
Conservative Dentistry and Endodontics at Kamineni Institute of Dental Sciences, Narketpally,
Nalgonda district, Telangana state, pincode:508254.
Nalgonda
TELANGANA
508254
India |
| Phone |
08309396512 |
| Fax |
|
| Email |
drsamalaanuhya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SAMALA ANUHYA |
| Address |
KAMINENI INSTITUTE OF DENTAL SCIENCES, Room number 7,Department of
Conservative Dentistry and Endodontics, Narketpally,
Nalgonda district, Telangana state, pincode:508254. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| S JAYAPRADA REDDY |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SAMALA ANUHYA |
Kamineni Institute of Dental Sciences |
Room number 7, Department of
Conservative Dentistry and Endodontics at Kamineni Institute of Dental Sciences, Narketpally,
Nalgonda district, Telangana state, pincode:508254.
Nalgonda
TELANGANA |
8309396512
drsamalaanuhya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kamineni Institutional Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
symptomatic irreversible pulpitits |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ARTICAINE |
THREE TO SIX MONTHS |
| Intervention |
DEXAMETHASONE |
THREE TO SIX MONTHS |
| Intervention |
KETEROLAC |
THREE TO SIX MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals with no systemic diseases.
Mandibular molars diagnosed as hot tooth with symptomatic irreversible pulpitis.
Carious exposed symptomatic mandibular molars.
A positive and prolonged response to cold tests and electric pulp tests.
|
|
| ExclusionCriteria |
| Details |
Patients with a history of known or suspected drug abuse, and patients taking any drugs that could have affected the pain perception.
Patients having active pain in more than one tooth were excluded from the study.
Teeth with fused roots, radiographic evidence of an extra root, large restorations with overhanging margins, full crowns.
Teeth with periodontal diseases and large peri-apical lesions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The aim of this randomized double-blinded clinical study was to evaluate and compare the efficacy of intra-ligamentary injection using articaine, ketorolac and dexamethasone for reduction of endodontic pain in patients with symptomatic irreversible pulpitis in permanent mandibular molars. |
Outcome for pain reduction will be assessed 5 mins after intervention with the drugs and heart rate will be monitored every minute upto 5 minutes after intervention with the drugs as intraligamenntary injection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate heart rate using finger pulse oximeter. |
At 15-second intervals until 5 minutes after intra-ligamentary injections. The timer for heart rate measurement started after the end of the distal injections. |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="81"
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)
|
19/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/02/2026 |
| 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 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
|
A total of 81 patients experiencing endodontic pain and requiring root canal treatment were enrolled after informed consent. Following baseline VAS assessment, all patients received a standard Inferior Alveolar Nerve Block using 2 percent Lignocaine with Adrenaline. Those who experienced pain during access cavity initiation were included. Participants were randomised via sealed envelopes into three groups to receive an intraligamentary injection of either articaine, dexamethasone, or ketorolac. The double-blind technique was employed, and injections were administered with back-pressure at the mesiobuccal and distobuccal line angles. Post-injection VAS scores were recorded upon pulpal chamber access. In cases of persistent pain, intrapulpal lignocaine was used. Standardised endodontic procedures followed, including rubber dam isolation, working length determination, rotary instrumentation, irrigation with EDTA and sodium hypochlorite, and obturation with gutta-percha and zinc oxide eugenol sealer using cold lateral compaction. Composite restoration completed the procedure. |