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CTRI Number  CTRI/2026/02/104383 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This study compares pain during dental injections using different anaesthetic solution given with a regular syringe and a Star Pen device in patients with painful lower back teeth. Also two different techniques is also used. Pain felt during the dental procedure is also evaluated. 
Scientific Title of Study   Comparative assessment of pain during administration of inferior alveolar nerve block with 2 percent lignocaine with 1:80000 adrenaline using conventional needle syringe and star pen and intraligamentary injection with 4 percent articaine with 1:100000 adrenaline using star pen and subsequently intraoperative pain in mandibular molar with symptomatic irreversible pulpitis of patient aged 18 to 50 years: A Randomized controlled trial. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rutuja Shah 
Designation  PG student 
Affiliation  MGVS KBH Dental College and Hospital, Nashik 
Address  MGV,S KBH Dental college and hospital Mumbai Agra highway panchavati Nashik India 422003
Mumbai Agra highway panchavati Nashik India 422003
Nashik
MAHARASHTRA
422003
India 
Phone  9067605427  
Fax    
Email  shahrutujaj22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Swapnil Kolhe 
Designation  Professor 
Affiliation  MGV,S KBH Dental college and hospital nashik 
Address  MGV,S KBH Dental college and hospital nashik

Nashik
MAHARASHTRA
422003
India 
Phone  9822198233  
Fax    
Email  endoswapnil33@gmail.com  
 
Details of Contact Person
Public Query  
Name  Swapnil Kolhe 
Designation  Professor 
Affiliation  MGV,S KBH Dental college and hospital nashik 
Address  MGV,S KBH Dental college and hospital nashik

Nashik
MAHARASHTRA
422003
India 
Phone  9822198233  
Fax    
Email  endoswapnil33@gmail.com  
 
Source of Monetary or Material Support  
Self. Rutuja Shah MGVs KBH Dental College, panchavti Nashik 422003 India  
 
Primary Sponsor  
Name  Rutuja shah 
Address  Fifth floor 502 department of conservative dentistry and endodontics. MGVS KBH dental college and hospital Nashik. India 422003 
Type of Sponsor  Other [self] 
 
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 Rutuja shah  MGVs KBH Dental College and Hospital Nashik  Fifth floor department number 502 conservative dentistry and endodontics. Mumbai Agra highway, panchavati, Nashik Maharashtra India 422003
Nashik
MAHARASHTRA 		 9067605427

shahrutujaj22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KBH Dental College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1. Lignocaine 2percent with 1:80000 adrenaline 2. Articiane 4 percent with 1:100000 adrenaline   These two different local anaesthesia is used int his study. 
Intervention  1. Manual syringe 2. Starpen  In this study manual syringe of 5 ml is used to give anaesthesia and in other two groups Starpen is used which is a battery operated device. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Mandibular molar with a diagnosis of acute / symptomatic irreversible pulpitis.
2.Mandibular molar with a diagnosis of acute/ symptomatic apical periodontitis.
 
 
ExclusionCriteria 
Details  1. Patients with any systemic disease and under NSAID or/and CNS acting drugs.
2. Intra and/or Extra- oral swelling.
3. Teeth with immature root apex.
4. Periodontally compromised teeth.
5. Pregnant patient.
Teeth with root resorption or calcified canals.
Retreatment cases.
Teeth with periapical pathology i.e. granuloma or radicular cyst
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare pain during administration of local anesthesia in three groups:
1. 2 percent lignocaine with 1:80,000 adrenaline via inferior alveolar nerve block using a conventional syringe.
2. 2 percent lignocaine with 1:80,000 adrenaline via inferior alveolar nerve block using a Star Pen.
3. 4percent articaine with 1:100,000 adrenaline via intraligamentary injection using a Star Pen. 		 60 second 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the intraoperative pain after administration of 2 percent lignocaine with 1:80000 adrenaline by inferior alveolar nerve block technique using conventional needle syringe on visual analogue scale.
2. To evaluate the intraoperative pain after administration of 2 percent lignocaine with 1:80000 adrenaline by inferior alveolar nerve block technique using star pen on visual analogue scale.
3. To evaluate the intraoperative pain after administration of 4 percent articaine with 1:100000 adrenaline by intraligamentary injection technique using star-pen on visual analogue scale.
4. To compare the intraoperative pain after administration of 2 percent lignocaine with 1:80000 adrenaline by inferior alveolar nerve block technique using conventional needle syringe & star pen & 4 percent articaine with 1:100000 adrenaline by intraligamentary injection technique during root canal treatment.
 		 20 minutes 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   10/03/2026 
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="1"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Group I: Administration of 2 perecnt lignocaine with 1:80000 adrenaline by

               inferior alveolar nerve block technique.

              The teeth will be anaesthetized with 2 percent lignocaine with    

              1:80000 epinephrine using conventional needle syringe.

               and 26 guage needle will be used.

Group II:  Administration of 2% lignocaine with 1:80000 adrenaline by  

                  inferior alveolar nerve block technique.

                 The teeth will be anesthetized with 2 percent lignocaine with

                 1:80000 epinephrine using star pen.

GroupI III: Administration of 4% articaine with 1:100,000 adrenaline by

                  intraligamentary injection technique (n=10). 

                  Teeth will be anaesthetized with 4 perecnt articaine with 1: 100000

                  epinephrine.

Patient will be administered 1.8ml of either 2 percent lignocaine with 1:80000 adrenaline or 4 percent articaine with 1:100000 adrenaline. Immediately after administration pain will be recorded using VAS. After administration of local anaesthesia will wait for 5 min. After 5 min, Access cavity preparation will be started using a round bur and safe end bur and canals will be located.

10k hand file will be inserted in each canal. Working length will be measured using electronic apex locator. Pulp extirpation will be done and temporary dressing will be given.

All patients will be evaluated by questionnaire based on a visual analogue scale following treatment to record their pain rating during treatment. The data will be collected based on the responses obtained by visual analogue scale. All patients will be explained the procedure to fill the visual analogue scale in advance.
 
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