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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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