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Clinical Trials/NCT05192902
NCT05192902
Completed
Not Applicable

Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia: Randomized Controlled Trial

University of Giessen1 site in 1 country60 target enrollmentSeptember 1, 2019
ConditionsPain Perception

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain Perception
Sponsor
University of Giessen
Enrollment
60
Locations
1
Primary Endpoint
Pain on Puncture (PoP)
Status
Completed
Last Updated
last year

Overview

Brief Summary

This single-blind two-arm randomized control trial (RCT) aims to evaluate the pain perception during and following administration of dental local anaesthesia using two different systems; i.e. computer-controlled (CCLA) and conventional.

Detailed Description

The administration of local anaesthesia (LA) is associated with pain, fear and anxiety. Computer-controlled LA (CCLA) aims to control the administration speed and reduce pain, fear and anxiety. This randomised control trial (RCT) aims to compare the pain perception after CCLA and conventional LA, and it uses dental students as both test and operator group versus an experienced dentist as an additional operator of the LA.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
December 31, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sameh Attia

Head of the Dental Polyclinic

University of Giessen

Eligibility Criteria

Inclusion Criteria

  • Dental students at the Faculty of Medicine, University of Giessen enrolled in the course of Local Anaesthesia.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pain on Puncture (PoP)

Time Frame: Within 2 hours

Self-reported pain intensity on puncture using visual analogue scale (0 = no pain- 10 = the worse pain)

Pain during Delivery (PdD)

Time Frame: Within 2 hours

Self-reported pain intensity during delivery of the anaesthetic solution sing visual analogue scale (0 = no pain- 10 = the worse pain)

Secondary Outcomes

  • Dental Anxiety (DA)(Within 2 hours)

Study Sites (1)

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