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
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pedo@npdch.edu.in].
- 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.
- 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. |