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CTRI Number  CTRI/2022/09/045799 [Registered on: 23/09/2022] Trial Registered Prospectively
Last Modified On: 02/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Pain free injection a novel technique  
Scientific Title of Study   COMPARATIVE EVALUATION OF 2% LIGNOCAINE GEL AND 2% AMITRIPTYLINE GEL IN REDUCING PAIN DURING ADMINISTRATION OF LOCAL ANAESTHESIA – A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchir Mehta 
Designation  POST GRADUATE STUDENT 
Affiliation  Narsinhbhai Patel Dental college and hospital 
Address  4,SIDDHACHAKRA APPARTMENT, NR.PUNCHSHIL BUS-STOP,
OPP.VISHWAKOSH BHAVAN, USHMANPURA,AHMEDABAD
Ahmadabad
GUJARAT
380013
India 
Phone  8690735319  
Fax    
Email  ruchir1904@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shoba Fernandes 
Designation  PROFESSOR AND HEAD 
Affiliation  Narsinhbhai Patel Dental college and hospital 
Address  A/103 SHARAN RESIDENCY-2,NEW CG ROAD,
NEAR DHANVIHAR RESIDENCY,CHANDKHEDA VILLAGE
Ahmadabad
GUJARAT
382424
India 
Phone  7567622346  
Fax    
Email  vshobaf@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shoba Fernandes 
Designation  PROFESSOR AND HEAD 
Affiliation  Narsinhbhai Patel Dental college and hospital 
Address  A/103 SHARAN RESIDENCY-2,NEW CG ROAD,
NEAR DHANVIHAR RESIDENCY,CHANDKHEDA VILLAGE
Ahmadabad
GUJARAT
382424
India 
Phone  7567622346  
Fax    
Email  vshobaf@gmail.com  
 
Source of Monetary or Material Support  
NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL,SANKALCHAND PATEL UNIVERSITY,AMBAJI GANDHINAGAR LINK ROAD , NEAR KAMANA CHAR RASTA,VISNAGAR, GUJARAT,INDIA-384315 
 
Primary Sponsor  
Name  NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL  
Address  SANKALCHND PATEL UNIVERSITY,AMBAJI-GANDHINAGAR LINK ROAD,NEAR KAMANA CHAR RASTA,VISNAGAR,NORTH GUJARAT-384315 
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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR RIYA THAKKAR  NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL   ROOM NO.5, DEPARTMENT OF COSERVATIVE AND ENDODONTICS, NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL SANKALCHAND PATEL VIDYADHAM AMBAJI GANDHINAGAR LINK ROAD NEAR KAMANA CHAR RASTA VISNAGAR 384315 NORTH GUJARAT
Mahesana
GUJARAT 
7874956791
02765233008
riyathakkar45@gmail.com 
DR RUCHIR MEHTA  NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL   ROOM NO.8, DEPARTMENT OF PEDIATRIC AND PRVENTIVE DENTISTRY, NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL SANKALCHAND PATEL VIDYADHAM AMBAJI GANDHINAGAR LINK ROAD NEAR KAMANA CHAR RASTA VISNAGAR 384315 NORTH GUJARAT
Mahesana
GUJARAT 
8690735319
02765233008
ruchir1904@gmail.com 
DR UJJAVAL BHAVSAR  NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL   ROOM NO.2, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL SANKALCHAND PATEL VIDYADHAM AMBAJI GANDHINAGAR LINK ROAD NEAR KAMANA CHAR RASTA VISNAGAR 384315 NORTH GUJARAT
Mahesana
GUJARAT 
8490088909
02765233008
ujjavalbhavsar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AMITRIPTYLINE GEL   2% w/v GEL OF 0.5 ML QUANTITY WILL BE APPLIED FOR 3 MINUTES IN CONTINUOUS MANNER AT THE SITE OF NEEDLE INSERTION 
Comparator Agent  LIGNOCAINE GEL  2% w/v GEL OF 0.5 ML QUANTITY WILL BE APPLIED FOR 3 MINUTES IN CONTINUOUS MANNER AT THE SITE OF NEEDLE INSERTION 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  SUBJECTS REQUIRING BILATERAL TREATMENT PROCEDURES WITH LOCAL ANESTHESIA INJECTION(BLOCK/INFILTRATION)
AND SUBJECTS FALLING UNDER THE CATEGORY OF ASA I AND ASA II

 
 
ExclusionCriteria 
Details  SUBJECTS ALLERGIC TO LOCAL ANESTHETIC AGENTS
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
BIOFEEDBACK
SOUNDS, EYE, MOTOR SCALE(SEM)
WONG BAKER FACIAL PAIN RATING SCALE(WBFPRS)
 
BASELINE,POST-INJECTION;POST-OPERATIVE 
 
Secondary Outcome  
Outcome  TimePoints 
TASTE ACCEPTANCE  POST-INJECTION 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
Final Enrollment numbers achieved (Total)= "174"
Final Enrollment numbers achieved (India)="174" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/09/2022 
Date of Study Completion (India) 01/04/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pedo@npdch.edu.in].

  6. For how long will this data be available start date provided 14-01-2024 and end date provided 14-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Dental pain management is one of the most critical aspects which might affect a patient’s quality of life. Injecting Local Anaesthesia (LA) in patients is an anxiety evoking procedure. Application of novel tricyclic antidepressants instead of conventional amide anaesthetics would be the revolutionary step in the field of topical anaesthesia. The aim is to evaluate the efficacy of 2% amitriptyline and 2% lignocaine gels in reducing pain during administration of local anaesthesia among population of Visnagar, Gujarat, India. It is a split mouth triple blind Randomized Control Trial which would include 174 patients aged 4-70 years requiring LA administration for pulpectomy, Root canal treatment, extraction and stainless-steel crown procedures. Each group will receive 0.5 ml gel prior to LA administration in subsequent visits. Evaluation criteria would comprise of biofeedback, taste acceptance, Wong Baker Facial Pain Rating Scale (WBFPRS) and Sounds, Eye, Motor scale (SEM).Suitable statistical analysis would be performed as per study design. A novel approach of 2% amitriptyline gel would be a gamechanger for dentists in painless needle insertion and vanish the trypanophobia among patients.

 
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