| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
|
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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. |