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CTRI Number  CTRI/2025/01/079023 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To Compare the Efficacy Of Preoperative Use Of Enzyme & Anti-Oxidant Based Painkiller Over A Plain Painkiller On The Nerve Block And Postoperative Pain Control In Root Canal Treatment Of Infected Molars. 
Scientific Title of Study   Comparative Efficacy Of Pre-Emptive Use Of Enzyme & Anti-Oxidant Based NSAID Over Plain NSAID On Inferior Alveolar Nerve Blockade And Postoperative Pain Control In Endodontic Treatment Of Molars With Symptomatic Pulpitis: A Randomized Controlled 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  Dr S Srija Mili 
Designation  PG Student 
Affiliation  MALLA REDDY DENTAL COLLEGE FOR WOMEN 
Address  Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Hyderabad
TELANGANA
500055
India 
Phone  08897300388  
Fax    
Email  ssmili401@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Swathi 
Designation  HOD, Proffesor 
Affiliation  MALLA REDDY DENTAL COLLEGE FOR WOMEN 
Address  Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Hyderabad
TELANGANA
500055
India 
Phone  09866021672  
Fax    
Email  drswathi.endo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Srija Mili 
Designation  PG Student 
Affiliation  MALLA REDDY DENTAL COLLEGE FOR WOMEN 
Address  Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055.
Hyderabad
TELANGANA
500055
India 
Phone  08897300388  
Fax    
Email  ssmili401@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama colony, Suraram, Hyderabad, Telangana, 500055, INDIA. 
 
Primary Sponsor  
Name  Malla Reddy Dental College for Women 
Address  Malla Reddy Dental College for Women,Venkatarama Colony, Suraram, Hyderabad, Telangana 500055 
Type of Sponsor  Private medical college 
 
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 S Srija Mili  MALLA REDDY DENTAL COLLEGE FOR WOMEN  Department of Conservative Dentistry and Endodontics, Room Number 107 and 108, Malla Reddy Dental College for Women, Venkatarama Colony, Suraram, Hyderabad, Telangana 500055.
Hyderabad
TELANGANA 
08897300388

ssmili401@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MALLA REDDY DENTAL COLLEGE FOR WOMEN INSTITUITIONAL ETHICS COMMITTEE  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, (2) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diclofenac sodium.  Diclofenac sodium 50mg to be given orally 60 minutes before the endodontic treatment. 
Intervention  Enzyme and Antioxidant based NSAID.  Composed of Bromelain 90mg, rutoside trihydrate 100mg, trypsin 48mg, diclofenac sodium 50mg to be given orally 60min before the endodontic treatment. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Mandibular molars diagnosed with Symptomatic Irreversible Pulpitis and Apical Periodontitis.
2. Had not taken any type of analgesic medication within the previous 12 h.
3. The absence of periapical radiolucency on radiographs, except for a widened periodontal ligament.
 
 
ExclusionCriteria 
Details  1. Patients allergic to diclofenac, bromelain, rutoside, trypsin, lidocaine or any other medication/ material used in study.
2. Diabetic, Hypertensive, Smoking, Pregnant or lactating women.
3. Any endocrine or infectious disease or had any systemic disease that contraindicate endodontic therapy.
4. Teeth with periodontal disease, necrotic tooth.
5. Radiographic images suggestive of internal or external resorptions.
6. Endodontic treatments not completed in a single session.
7. Failed to achieve adequate anesthesia (IANB).
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate the efficacy of the Enzyme and Antioxidant based NSAID as preoperative medication on the success of Inferior Alveolar Nerve Block.
 
NRS pain scale scored from 0 to 10, taken 15 minutes after the Inferior Alveolar Nerve Block. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare and evaluate the influence of the Enzyme and Antioxidant based NSAID as preoperative medication on the intensity of pain during the procedure and postoperative pain at 4 intervals i.e. at 6, 12, 24 and 48 hours.
 
NRS pain scale scored from 0 to 10 at 4 intervals i.e. at 6, 12, 24 and 48 hours. 
 
Target Sample Size   Total Sample Size="87"
Sample Size from India="87" 
Final Enrollment numbers achieved (Total)= "87"
Final Enrollment numbers achieved (India)="87" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Pain management during and after endodontic treatment is essential for both clinicians and patients. Thus, effective anesthesia and minimal postoperative pain is always considered to be of utmost importance during an endodontic treatment. 

Inferior alveolar nerve block (IANB) is preferred anesthetic technique for endodontic treatment of mandibular molars. However, success rate of IANB is quite low in patients with symptomatic irreversible pulpitis (SIP) in mandibular molars, ranging from 58% to 79%. Anesthetizing tooth with irreversible pulpitis poses a challenge as the voltage-gated sodium channels are resistant to local anesthetic relatively.  Anatomical variations, pulpal inflammation, failure of anesthetic technique and even anxiety caused by preoperative pain can explain anesthetic difficulty. 

In postoperative period following an endodontic procedure, approximately 47% of patients report moderate to severe pain, with a higher incidence between 6 and 24 h. The inflammatory process of the pulp involves pro-inflammatory chemical mediators, mainly prostaglandins, which have been shown to cause hyper-algesic effects in addition to inflammatory process. Although periapical inflammation has a significant influence on occurrence of postoperative pain, the presence of excruciating symptoms in preoperative period is one of the factors that can contribute to an increase in pain score. 

This study is an attempt to check whether additional factors like Bromelain, Trypsin (ENZYMES) and Rutoside trihydrate (ANTIOXIDANT) provide a synergistic action to the NSAID in pain control which indirectly provides its efficacy over nerve blockade

In the literature we have many studies proving the potency of various NSAIDs over the IANB success and postoperative pain, but there is a paucity of studies investigating an enzyme and antioxidant based NSAID’s efficacy over IANB success and pain control in endodontically treated molars, which forms the basis of this study research. 

The aim of the study is to compare and evaluate the efficacy of the Enzyme and Antioxidant based NSAID (Bromelain 90mg, rutoside trihydrate 100mg, trypsin 48mg, diclofenac sodium 50mg) and plain NSAID (Diclofenac sodium 50mg) as preoperative medication which is given 60 min before initiating the endodontic treatment and to assess its effect on the success of Inferior Alveolar Nerve Block, and to evaluate the influence of these drugs on the intensity of pain during the procedure and postoperative pain at 4 intervals i.e. 6, 12, 24 and 48 hours.

 

 
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