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CTRI Number  CTRI/2018/05/013763 [Registered on: 08/05/2018] Trial Registered Prospectively
Last Modified On: 07/05/2018
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 clinical trail to study the effects of two tablets in patients with tooth ache during root canal treatment. 
Scientific Title of Study   COMPARATIVE CLINICAL EVALUATION OF EFFECT OF PREOPERATIVE ORAL TRAMADOL AND KETOROLAC ON THE SUCCESS OF INFERIOR ALVEOLAR NERVE BLOCK IN PATIENTS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS -A RANDOMIZED CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Miriyala Chaitanya 
Designation  Post graduate student 
Affiliation  narayana dental college and hospital 
Address  Department of conservative dentistry and endodontics,Narayana dental college, Chinthareddypalem, Nellore.
E.V.R.palli, Gudur , Nellore(D.T)
Nellore
ANDHRA PRADESH
524002
India 
Phone  9440612577  
Fax  09440612577  
Email  chaitugdc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr A Lavanya 
Designation  Professor 
Affiliation  Narayana dental college and hospital 
Address  Room no.4, first floor,Narayana dental college and hospital Chintareddy palem Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9346567413  
Fax    
Email  lavanyamds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suneel kumar Chinni 
Designation  Professor 
Affiliation   
Address  room no.4, First floor,Narayana dental college and hospital Chintareddy palem Nellore

Nellore
ANDHRA PRADESH
524003
India 
Phone  9966313666  
Fax    
Email  chinnisk@yahoo.com  
 
Source of Monetary or Material Support  
Narayana dental college and hospital, Chinthareddypalem, Nellore, (A.P),India. Pincode: 524003 
 
Primary Sponsor  
Name  Narayana dental college and hospital 
Address  First floor, Room no.4, Dept. of Conservative dentistry and Endodontics, narayana dental college and hospital,nellore. 
Type of Sponsor  Other [Private dental college 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 Chaitanya Miriyala  Narayana dental college  Room no.4, First floor, Narayana dental college chinthareddy palem,nellore.
Nellore
ANDHRA PRADESH 
9440612577

chaitugdc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  symptomatic irreversible pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  ketorolac  10mg tablet one hour before the start of root canal treatment  
Intervention  tramadol  50mg one tablet one hour start of Root canal treatment 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.The patients have not taken any analgesics for at least 12 hours before enrollment in the study.

2.Patients with symptomatic irreversible pulpitis of any mandibular posterior teeth.

3.Absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament.

 
 
ExclusionCriteria 
Details  1.Subjects under 18 years of age.
2.Known allergy, sensitivity, or contraindications to any opioid or non-opioid analgesic NSAIDs and local anesthetics.
3.History of active peptic ulcer within the preceding 12 months.
4.Pregnant or nursing women.
5.History of known or suspected drug abuse.
6.Patients who had taken NSAIDs within 12 hours before administration of the study drugs.
7.Patients with a history of significant medical conditions.
8.Patients unable to give informed consent.
9.Patients having pain in more than 1 mandibular posterior teeth
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Evaluation of pain during access opening of Root canal treatment after giving inferior alveolar nerve block  15 minutes 30 minutes 45 minutes After administration of inferior alveolar nerve block 
 
Secondary Outcome  
Outcome  TimePoints 
pain free root canal treatment  after 1hr 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   16/05/2018 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   will be published after completion of the study. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Irreversible pulpitis is a persistent inflammatory condition of the pulp, symptomatic or asymptomatic caused by a noxious stimulus. (Pain is usually spontaneous or caused by hot or cold stimulus that persists for several minutes to hours, lingers after the removal of the stimulus). Pain is a significant symptom of irreversible pulpits makes the patient to seek treatment as quickly as possible. The best treatment option for irreversible pulpitis is pulp therapy which is nothing but endodontic access preparation and removal of pulpal tissue.  

                The inflamed pulp have high sensitivity, so the treatment process of induces pain, the pain of both pulpitis and treatment may combine leading the patient unco-operative during the treatment .So the local anesthesia is of most important. Inferior alveolar nerve block is given for the mandibular posterior teeth. The problem is always obtaining a satisfactory anesthetic effect is not possible, which would make patient not comfortable and clinician not confident during the treatment, especially when inflamed teeth are involved.

                     The possible reasons could be 1. low ph of inflamed tissues at the injection site and less conversion of the local anesthetic agent to their non ionized fat soluble form which is necessary to penetrate the nerve sheath. 2. Nerves within the inflamed tissue have altered resting potentials so that excitable threshold decreases. 3. Increased tetredotoxin receptors at the inflamed tissue .4.various anatomies such as accessory innervations and cross innervations .5.Tachyphylaxis of anesthetic agent.

                       If we can supplement the IANB with an analgesic there can be increased patient co-operation and clinician comfort. Many clinical studies have compared various preoperative analgesic medications to supplement IANB. Tramadol has been reported as an effective analgesic for post endodontic pain.

                        The aim of the study is to compare the effect of both oral Ketorolac and oral Tramadol for the success of IANB with current clinical evidence.

Source of data

•      Patients visiting the Outpatient Department of Conservative Dentistry and Endodontics in Narayana Dental College and Hospital, Nellore, Andhra pradesh, with symptomatic irreversible pulpitis of the mandibular molars.

1.     70 teeth will be randomly assigned into 2 Groups with 35 in each Group.

2.    Patients will be checked clinically and radio-graphically to diagnose symptomatic irreversible pulpitis.

3.    Randomization and blinding of the tablets will be done. Either tramadol or ketorolac will be given to patient.

4.    Patients will be asked to wait for an hour to start of access preparation.

5.    IANB will be given before starting of the procedure. 

Prior to the treatment patients demographic details and thorough history of presenting illness will be recorded. Patient is examined by visual analogue scale in which patient will place a pencil mark at on scale from 0 to 10 where 0 is no pain and 10 is worst pain possible. Randomization and blinding of the tablets will be done. Either of tramadol or ketorolac will be given to patient and asked to wait for an hour. Starting the procedure by giving inferior alveolar nerve block with 2ml of 2% lignocaine with 1 in 80,000 dilution of adrenaline will be given, after 15 minutes the procedure will be started.

                During the treatment, while entering dentin, pulp and during removal of pulpal tissue if any pain felt by patient will be noted with visual analogue scale.  If the patient requires second block or intra -ligamentary and intra- pulpal injections such patients will be excluded 

 

 
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