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CTRI Number  CTRI/2019/03/018244 [Registered on: 25/03/2019] Trial Registered Prospectively
Last Modified On: 24/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   oral analgesia for root canal treatment  
Scientific Title of Study   comparative evaluation of pre emptive and preventive analgesic effect of oral ibuprofen in single visit root canal treatment- A prospective randomised study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavalipurapu Venkata Teja 
Designation  postgraduate student 
Affiliation  saveetha dental college and hospitals, saveetha institute of medical and technical sciences 
Address  Department of conservative dentistry and endodontics Room no 21 162 poonamallee high road Velapanchavadi
Department of conservative dentistry and endodontics Room no 21 162 poonamallee high road Velapanchavadi
Chennai
TAMIL NADU
600077
India 
Phone  7397439814  
Fax    
Email  venkatteja77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sindhu Ramesh 
Designation  professor and head 
Affiliation  saveetha dental college and hospitals, saveetha institute of medical and technical sciences 
Address  Department of conservative dentistry and endodontics Room no 21 162 poonamallee high road Velapanchavadi
Department of conservative dentistry and endodontics Room no 21 162 poonamallee high road Velapanchavadi
Chennai
TAMIL NADU
600077
India 
Phone  98401363543  
Fax    
Email  drsinsushil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kavalipurapu Venkata Teja 
Designation  postgraduate student 
Affiliation  saveetha dental college and hospitals, saveetha institute of medical and technical sciences 
Address  Department of conservative dentistry and endodontics Room no 21 162 poonamallee high road Velapanchavadi
Department of conservative dentistry and endodontics Room no 21 162 poonamallee high road Velapanchavadi
Chennai
TAMIL NADU
600077
India 
Phone  7397439814  
Fax    
Email  venkatteja77@gmail.com  
 
Source of Monetary or Material Support  
Kavalipurapu Sai Vara Prasad (Father) house no 29-1382, east kakitya nagar, road no 8. meerudmut, hyderabad telangana  
 
Primary Sponsor  
Name  Kavalipurapu Sai Vara Prasad  
Address  Jeq-19, Godavari block, Mahindra Limited zaheerabad Medak Telangana  
Type of Sponsor  Other [Father] 
 
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 
Kavalipurapu Venkata Teja  saveetha dental college and hospitals, saveetha institute of medical and technical sciences   Department of conservative dentistry and endodontics Room no 21 162 poonamallee high road velapanchavadi,
Chennai
TAMIL NADU 
7397439814

venkatteja77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ibuprofen   600mg. oral route administration. duration is one hour prior to root canal treatment 
Comparator Agent  ibuprofen  dose 200 mg. oral route administration. drug to be taken three times a day for one day if there is pain postoperative to root canal treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  patients without any medical history
systemically healthy patients
teeth with symptomatic irreversible pulpitis 
 
ExclusionCriteria 
Details  patient under drug history
teeth with calcification
teeth with anatomical variation
teeth with incomplete root formation 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
primary outcome: Postoperative pain levels.
 
pre emptive and post operative analgesic intake during root canal treatment 
 
Secondary Outcome  
Outcome  TimePoints 
secondary outcome: Postoperative analgesic intake  pre emptive and post operative analgesic intake during root canal treatment 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/04/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/11/2019 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   .BACKGROUND
The pain is the primary reason for which most of the patients seek endodontic treatment frequently. Endodontic procedures play an important role in restoring and treating a tooth which is affected irreversibly by bacterial invasion and infection. It usually aims in the complete debridement of inflamed and necrotic pulp tissue from the root canal space and sealing it from the external environment. There is an effective relief in pain, preceding an appropriate and flawless endodontic procedure. However, the relief in the pain levels, may not be immediate and absolute. Although it is diminished to some extent, immediately following the root canal treatment in most of the patients, 30% of them still experience moderate to severe postoperative pain due to the residual effects of inflammation.So an endodontic procedure should consider both primary concerns of the patient and long term complications such as postoperative pain. Pain is usually at its worst in the first 24 hours postoperatively after an orthograde endodontic procedure and gradually the levels decrease in the subsequent 3 to 7 days 
Mechanical, thermal, chemical and immunological stimulation of afferent nociceptors, which synapse in the dorsal horn of spinal cord lead to direct sensation of thalamus and presents as pulpal and periapical pain The stimulation of nociceptors is prevalently by the endogenous inflammatory mediators such as bradykinin, calcitonin-gene related peptide, substance p, growth factors, cytokines, chemokines and arachidonic acid.These are generated as part of innate immune response following a tissue injury or destruction. Arachidonic acid metabolite is converted to prostaglandin by enzymes such as cyclooxygenase enzyme 1 and 2 (COX-1, COX-2). The converted prostaglandins in turn cause the sensitization of afferent nociceptors leading to decreased pain threshold . Therefore pharmacologic interventions mainly aim in targeting cyclooxygenases thereby limiting the prostaglandin production and limiting the sensitization of nerve fibres .
Perception of pain is highly subjective and variable experience. It is not only influenced by the treatment procedure being performed but multiple physical and psychological factors also play a role in perceiving pain. Conventional dental procedures are associated with pain postoperatively, but the incidence and severity is highest with root canal therapy. The main contributing reason for postoperative endodontic pain is because of the extrusion of canal contents, debris and microbes from root canal space to periapical area, leading to intense inflammatory response and infection. Various non-narcotic analgesics like NSAID`S are majorly used in treating the endodontic pain. The mechanism of action is mainly by inhibiting prostaglandin synthesis at the sites of inflammation. Several clinical studies have evaluated the use of NSAID`S for treating the postoperative pain in endodontics with conflicting results. Some studies state conclude the beneficial effect in administration of non-narcotic analgesics whereas others claim no efficient results(10),(11). Various other drugs that are used along with NSAID`S include opioids and combination of drugs for treating endodontic pain.
In many studies, the drugs were prescribed preoperatively and postoperatively to reduce the endodontic pain showed conflicting results. Pre-emptive analgesia is an anti-nociceptive treatment which amplifies the postoperative pain by preventing the processing of altered afferent input. As most of the patients presents with pain pre-operatively, have higher levels of inflammatory mediators being released. Thus, pre-treatment analgesia decreases the establishment of central sensitization, a mechanism by which spinal neurons increase their response to peripheral nociceptive impulse.

 Therefore the aim of this study to cocompare and evaluate the postoperative pain levels and analgesic intake on preoperative oral administration of NSAIDs in single visit root canal treatment.
 
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