MedPath

Pain free injection a novel technique

Phase 2/3
Completed
Conditions
Other and unspecified diseases ofpulp and periapical tissues,
Registration Number
CTRI/2022/09/045799
Lead Sponsor
NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL
Brief Summary

Dental pain management is one of the most critical aspects which might affect a patient’s quality of life. Injecting **L**ocal **A**naesthesia (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 **R**andomized **C**ontrol **T**rial which would include174 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, **W**ong **B**aker **F**acial **P**ain **R**ating **S**cale (WBFPRS) and **S**ounds, **E**ye, **M**otor 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
174
Inclusion Criteria

SUBJECTS REQUIRING BILATERAL TREATMENT PROCEDURES WITH LOCAL ANESTHESIA INJECTION(BLOCK/INFILTRATION) AND SUBJECTS FALLING UNDER THE CATEGORY OF ASA I AND ASA II.

Exclusion Criteria

SUBJECTS ALLERGIC TO LOCAL ANESTHETIC AGENTS.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
BIOFEEDBACKBASELINE,POST-INJECTION;POST-OPERATIVE
WONG BAKER FACIAL PAIN RATING SCALE(WBFPRS)BASELINE,POST-INJECTION;POST-OPERATIVE
SOUNDS, EYE, MOTOR SCALE(SEM)BASELINE,POST-INJECTION;POST-OPERATIVE
Secondary Outcome Measures
NameTimeMethod
TASTE ACCEPTANCEPOST-INJECTION

Trial Locations

Locations (1)

NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL

🇮🇳

Mahesana, GUJARAT, India

NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL
🇮🇳Mahesana, GUJARAT, India
DR RIYA THAKKAR
Principal investigator
7874956791
riyathakkar45@gmail.com
DR RUCHIR MEHTA
Principal investigator
8690735319
ruchir1904@gmail.com
DR UJJAVAL BHAVSAR
Principal investigator
8490088909
ujjavalbhavsar@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.