| CTRI Number |
CTRI/2026/01/101414 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A drug to assess pain in patients with Tooth ache |
|
Scientific Title of Study
|
Diclofenac sodium as an intra canal medicament in Patients with Symptomatic Irreversible Pulpitis: A Randomised Controlled 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 |
Dr Santhosh Kumar A |
| Designation |
Post graduate |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Department of Conservative Dentistry and Endodontics Chettinad Dental College and Research Institute, E Block, Rajiv Gandhi Salai, Kelambakkam, Chengalpattu, Tamil Nadu India, 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
6379114966 |
| Fax |
|
| Email |
santhoshkumarendodontist@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreeram SR |
| Designation |
Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Department of Conservative Dentistry and Endodontics Chettinad Dental College and Research Institute, E Block, Rajiv Gandhi Salai, Kelambakkam, Chengalpattu, Tamil Nadu India, 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9995622233 |
| Fax |
|
| Email |
drram101@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreeram SR |
| Designation |
Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Department of Conservative Dentistry and Endodontics Chettinad Dental College and Research Institute, E Block, Rajiv Gandhi Salai, Kelambakkam, Chengalpattu, Tamil Nadu India, 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
9995622233 |
| Fax |
|
| Email |
drram101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Dental College and Research Institute, E Block, Rajiv Gandhi Salai, Kelambakkam, Chengalpattu, Tamil Nadu, India, 603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College and Research Institute |
| Address |
Chettinad Dental College and Research Institute, E Block, Rajiv Gandhi Salai, Kelambakkam, Chengalpattu, Tamil Nadu India, 603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sreeram SR |
Chettinad Dental College and Research Institute |
Room number 10, Department of Conservative Dentistry and Endodontics, E Block, Rajiv Gandhi Salai, Kelambakkam, Chengalpattu, Tamil Nadu India, 603103
Chennai
TAMIL NADU |
9995622233
drram101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Chettinad Dental College and Research Institute (IHEC-CDCRI) |
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 |
| Comparator Agent |
Calcium hydroxide group |
Placement of Calcium Hydroxide as an intracanal medicament |
| Intervention |
Diclofenac group |
Placement of Diclofenac sodium as an intracanal medicament |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mandibular 1st and 2nd Molar Teeth with symptomatic apical periodontitis and Teeth with necrotic pulp that gave a negative response to vitality testing |
|
| ExclusionCriteria |
| Details |
I. Non restorable tooth
II. Presence of endo perio lesions
III. teeth associated with an acute or chronic apical abscess
IV. teeth with chronic periodontitis;
V. Teeth with anatomical difficulties, such as open apices;
VI. Teeth with calcified canals;
VII. Teeth with severe dilacerations;
VIII. Teeth with internal/external root resorption;
IX. Teeth with occlusal interferences;
X. Patients who are allergic to medications that are used in the study;
XI. Patients who are taking medicines that could influence pain perception;
XII. Patients that had serious medical illness; XIII. Patients with systemic disorders;
XIV. Patients with immunocompromised diseases such as AIDS or HBV |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain in patients with symptomatic apical periodontitis |
Base line, 4h hours, 48 hours, 72 hours, 96 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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 4 |
|
Date of First Enrollment (India)
|
06/02/2026 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Diclofenac sodium is a nonsteroidal anti-inflammatory
drug (NSAID) developed in the 1960s and widely used since the 1970s for its
analgesic, anti-inflammatory, and antipyretic effects. It works by inhibiting
COX enzymes, thereby reducing prostaglandin synthesis—key mediators of
inflammation and pain.
Recently Diclofenac has gained attention for its
Anti-microbial Properties, various in-vitro studies have been conducted
evaluating the antimicrobial efficiency of diclofenac sodium. However, there is
no proper clinical data available evaluating this antimicrobial effect in
in-vivo conditions which will implicate post operative pain has yet to be done.
Additionally, diclofenac exhibits antimicrobial properties, showing
effectiveness against resistant endodontic pathogens like Enterococcus
faecalis. This gives it an advantage over traditional medicaments like
calcium hydroxide as a potential intracanal medicament. Its anti-inflammatory
action helps reduce periapical inflammation, thereby minimizing post-operative
pain.
Moreover, its
analgesic effects may provide localized pain relief during root canal
procedures, enhancing patient comfort. Preliminary studies also suggest good
biocompatibility when used in endodontic settings. While promising, further
clinical research is needed to establish standardized protocols for its use.
Diclofenac’s combined anti-inflammatory, antimicrobial, and analgesic
properties make it a valuable candidate for improving outcomes in root canal
therapy. |