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