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Comparison Between the Dentapen and Vibraject

NCT06790433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-24

No results posted yet for this study

Summary

A split-mouth, controlled trial aimed to assess patient-reported pain levels during local anaesthesia administration to the buccal side of the maxillary posterior teeth using Vibraject-assisted injection and the Dentapen® system in its ramp-up mode.

Pain intensity was evaluated using the Visual Analogue Scale immediately following each injection, and heart rate measurements were recorded before and after each injection. Patient preferences for injection methods were also documented

Conditions

Interventions

DEVICE

Vibraject

The needle was advanced into the tissue until it was estimated to be over the root apex while remaining parallel to the tooth's long axis. The Vibraject was activated after aspiration to deposit the solution slowly at approximately 50 seconds. Following cartridge deposition, the operator adjusted the participant to an upright seated position

DEVICE

Dentapen

The needle was advanced into the tissue until it was estimated to be over the root apex while remaining parallel to the tooth's long axis (needle placement). The Dentapen was activated after aspiration to deposit the solution at a medium rate (1 mL/60 s) using the ramp-up mode. Following cartridge deposition, the operator adjusted the participant to an upright seated position

Sponsors & Collaborators

  • Riyadh Elm University

    lead OTHER

Principal Investigators

  • ِAmmar AbuMostafa, MSc · Riyadh Elm University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2023-12-30
Completion
2024-02-02

Countries

  • Saudi Arabia

Study Locations

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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 NCT06790433 on ClinicalTrials.gov