| CTRI Number |
CTRI/2026/01/102332 [Registered on: 28/01/2026] 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
|
Doxycycline as an intra canal medicament in Patients
with Symptomatic Irreversible Pulpitis: A Randomized 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
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 (5 days) |
| Intervention |
Doxycycline group |
Placement of Doxycycline as an intracanal medicament (5 days) |
|
|
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, 4 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)
|
27/02/2026 |
| 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
|
Successful endodontic therapy hinges on the effective
elimination of microorganisms from the root canal system, particularly in cases
involving infected root canals. Despite mechanical instrumentation and
irrigation, complete disinfection remains a challenge due to the complex
anatomy of the root canal and the presence of resistant microbial biofilms. As
a result, intracanal medicaments are employed to enhance microbial control
between treatment sessions.
Doxycycline, a broad-spectrum, semi-synthetic
tetracycline antibiotic, has emerged as a promising intracanal medicament due
to its potent antimicrobial activity, substantivity, and anti-collagenase
properties. Unlike calcium hydroxide, doxycycline is
effective against a wide range of both aerobic and anaerobic bacteria and
demonstrates superior penetration into dentinal tubules. Moreover, its capacity
to inhibit matrix metalloproteinases contributes to the preservation of
periapical tissues and supports the healing process. When used within the canal, doxycycline not only
targets a broad range of endodontic pathogens but also aids in the preservation
of dentinal collagen, promoting periapical healing.
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. |