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Effect of Different Approaches of Delivering Local Dental Anesthesia on Pain Perception in Children.

NCT05338983 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-04-29

No results posted yet for this study

Summary

The aim of the study is to compare the efficacy of three different approaches of local anesthesia (LA) administration (Warm\[37°C\] LA, Buffered LA, and BUZZY device) on pain perception to young children ( 6-12 years old) using sound -eye -motor and Wong-Baker FPR scales.

Conditions

  • Pain
  • Local Anesthetics
  • Epinephrine
  • Vibration

Interventions

DRUG

Topical anesthetic

20% Benzocaine gel will be applied on the area of infiltration

DEVICE

Avent baby bottle warmer

Warming device

DRUG

Sodium bicarbonate

0.1ml of 8.4% of sodium bicarbonate will be removed from the 50ml vial by one ml insulin syringe , directly injected into the local anesthetic cartridge and will be shacked 5 times to mix the solution.

DEVICE

Buzzy device

Bee-shaped apparatus consisting of two parts: the main vibrating body of a bee and detachable ice wings. External application of Buzzy device during administration of dental anesthetic.

DRUG

Mepivacaine Hydrochloride

Mepivacaine HCL 2% with Epinephrine 1:100,000 Local Anesthetic. Local Dental anesthetic infiltration

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Sahar H Zidan · Dentist at Ministry of Health B.D.S (2013), Diploma (2016)

  • Nadia M Farrag · Professor of Pediatric Dentistry Faculty of Dentistry, Mansoura University

  • Ahmed H Wahba · Lecturer of Pediatric Dentistry Faculty of Dentistry Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-05-01
Completion
2023-06-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05338983 on ClinicalTrials.gov