Local Anesthesia With Needle-free Injection System

Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth


Lead Sponsor: Sinem yildirim

Source Okan University
Brief Summary

The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).

Overall Status Completed
Start Date June 1, 2018
Completion Date June 15, 2019
Primary Completion Date May 15, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Wong-Baker Faces Pain Rating Scale (PRS) 1 year
Face, Legg, Cry, Consolability Scale (FLACC) 1 year
Enrollment 60

Intervention Type: Device

Intervention Name: Comfort-in injection system

Description: local anesthesia during dental treatment

Arm Group Label: experimental

Intervention Type: Other

Intervention Name: conventional injection with dental needle

Description: for local anesthesia during dental treatment

Arm Group Label: conventional injection



Inclusion Criteria:

- In need of treatment of right and left molar teeth of mandible,

- Does not have any systemic disorder,

- High level of communication that can provide logical answers to the questions we ask

- With parental consent,

- Volunteers who want to participate in the research

- 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria:

- No need for treatment of right and left molar teeth of mandible,

- Has a systemic condition

- Low level of communication that cannot provide reasonable answers to the questions we ask

- Without parental consent

- Do not want to participate voluntarily in the research

- Do not attend a check-in

- Patients not in the 6-12 age group

Gender: All

Minimum Age: 6 Years

Maximum Age: 12 Years

Healthy Volunteers: Accepts Healthy Volunteers

Facility: Okan University Faculty of Dentistry
Location Countries


Verification Date

July 2019

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Okan University

Investigator Full Name: Sinem yildirim

Investigator Title: Assistant Professor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: experimental

Type: Experimental

Description: local anesthesia applyed with Comfort in system

Label: conventional injection

Type: Active Comparator

Description: local anesthesia applyed with conventional syringe

Acronym anesthesia
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov