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CTRI Number  CTRI/2018/04/013077 [Registered on: 05/04/2018] Trial Registered Prospectively
Last Modified On: 12/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of time at which the patient starts feeling the numbness and its duration and quality after local anesthesia injection using computerised injection system 
Scientific Title of Study   A randomised split mouth clinical trial comparing anaesthetic efficacy of Articaine in inferior alveolar nerve block with conventional syringe versus computer controlled delivery technique 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Deshpande 
Designation  Post Graduate student 
Affiliation  Sinhgad Dental College and hospital Pune 
Address  Sinhgad Dental College and hospital 44/1 Off Sinhgad road Pune

Pune
MAHARASHTRA
411 041
India 
Phone  9423581305  
Fax    
Email  nehadeshpande9991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipali Shah 
Designation  Professor 
Affiliation  Sinhgad Dental College and hospital Pune 
Address  Sinhgad Dental College and hospital 44/1 Off Sinhgad road Pune

Pune
MAHARASHTRA
411 041
India 
Phone  9890195100  
Fax    
Email  dipali.nagda@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Dipali Shah 
Designation  Professor 
Affiliation  Sinhgad Dental College and hospital Pune 
Address  Sinhgad Dental College and hospital 44/1 Off Sinhgad road Pune

Pune
MAHARASHTRA
411 041
India 
Phone  9890195100  
Fax    
Email  dipali.nagda@yahoo.com  
 
Source of Monetary or Material Support  
Sinhgad dental college and hospital Pune 
 
Primary Sponsor  
Name  Dr Neha Deshpande 
Address  Sinhgad dental college and hospital 44/1 Off Sinhgad road Vadgaon Budruk Pune 411041 
Type of Sponsor  Other [Dr Neha Deshpande] 
 
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 Neha Deshpande  Sinhgad Dental college and hospital Pune  Department of Conservative Dentistry and endodontics Lower ground floor Room number 7 44/1 Off Sinhgad road Vadgaon Budruk Pune
Pune
MAHARASHTRA 		 9423581305

nehadeshpande9991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sinhgad Dental college and hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Contralateral vital permanent mandibular molars with asymptomatic apical periodontitis  
Patients  Bilateral mandibular molars with asymptomatic apical periodontitis ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional cartridge and needle and computer controlled local anaesthesia delivery system  Inferior alveolar nerve block administed using Conventional cartridge ans needle and computer controlled local anaesthesia delivery system on bilateral mandibular molars requiring endodontic treatment 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients willing to participate in the study
Age group : 20 - 45 years
Patients who require local anesthetic injections on at least 2 occassions on bilateral mandibular molars for endodontic procedures
Mandibular permanent molars, with fully formed roots (confirmed by periapical radiograph) with asymptomatic apical periodontitis and asymptomatic pulpitis
Pulp tests: Delayed response with Electric pulp tester(EPT)
Radiograph : Widening of PDL space with intact lamina dura
Patients would not have undergone any previous dental local anesthetic experience, in order to be not influenced by a positive or a negative memory
Patient would not have taken any medication for the past 2 weeks
 
 
ExclusionCriteria 
Details  Patients not willing to participate in the study
Pregnant patients
History of allergy to the components of the local anesthetic solutions
Patients who received local anesthesia before the experiment
Subjects with systemic diseases
Patients on any kind of medication
Patients with psychiatric illness
Unco-operative patients
Active sites of infection in the area of injection
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Anesthetic effect of 4% Articaine with 1:100,000 epinephrine  Onset: time when the patient starts feeling tingling sensation on the lip
Duration : time when the patient stops feeling any numbness

Duration :  
 
Secondary Outcome  
Outcome  TimePoints 
Effect of anesthesia or depth of anesthesia  Any pain during treatment is considered anesthesia failure 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/04/2018 
Date of Study Completion (India) 03/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The proposed study will be forwarded to Institutional Ethical Committee for its clearance.

100 adult patients in the age group of 20-45 years willing to participate in the study will be selected by simple random sampling from the Out Patient Department(OPD) at the Department of Conservative Dentistry and Endodontics, Sinhgad Dental college and hospital, Pune. Informed consent will be obtained from each patient.

100 patients in the age group of 20-45 years requiring local anesthesia for endodontic therapy in the mandibular molars with asymptomatic apical periodontitis with asymtomatic pulpitis would be selected

Mandibular molars with asymtomatic apical periodontitis and asymtomatic pulpitis,  radiographically showing intact lamina dura with widening of periodontal ligament space

The patients would be asked to pick up a chit to decide the local anesthesia delivery system to be used in the 1st appointment

Intervention 1 : Inferior alveolar nerve block would be  administered on one side of the arch using 4% Articaine with 1:100,000 epinephrine  with a 27 gauge 11/2 inch needle with the local anesthesia delivery technique according to the chit taken out by the patient, after a 60-seconds application of topical anesthetic gel (5% Lidocaine gel)

Enrolled patients would receive 1.7 mL 4%Articaine with 1:100,000 epinephrine (Septanest, Septodont,France)

All the injections would be given by the same operator and the second operator would note the readings like lip numbness, pain during injection, during access cavity preparation or the instrumentation procedure till the completion of endodontic treatment

Rate of delivery/ Speed of injection :

•         For conventional technique : 1ml/minute

•         For Computer-controlled anesthesia : 1ml/minute

The endodontic treatment would be completed and any pain during the procedure would be noted

Intervention 2 : After 1 week from the 1st appointment, inferior alveolar nerve block would be  administered on the other side of the arch in a similar way using the second local anesthesia delivery technique and endodontic procedure completed

Onset of action of the local anesthetic would be determined by asking the patient to report the start of lip numbness or tingling sensation

Absence of pain during access preparation or instrumentation  would be considered as anesthesia success

Pain at any point of the endodontic procedure is considered as anesthetic failure

If there is pain during endodontic procedure , a buccal infiltration or a second inferior alveolar nerve block would be administered

Duration of action of local anesthetic would be determined by asking the patient to record the time after which he/she stops feeling the numbness

 

 

1.     Injection by Conventional anesthetic technique: The inferior alveolar nerve block will be administered for one side mandibular molar with a 27-gauge, long (11/2 inch) needle.

2.     Injection by the CCLAD : No Pain III would be the equipment used for computer controlled local anesthesia delivery. The equipment comprises of disposable handpiece component and a computer control unit. Handpiece is an ultra-light pen like handle, which is linked to an anesthetic cartridge, with a plastic micro-tubing. Procedure would be followed as per the manufacturer’s instructions. The delivery of local anesthesia will be done under cruze control mode of the equipment at slow speed, regulated, by a pedal/foot control.

 
 
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