Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia

Not Applicable

Completed

• Conditions: Pain Perception
• Interventions: Device: Computer-controlled Local Anaesthesia (CCLA); Device: Conventional Local Anaesthesia

• Registration Number: NCT05192902
• Lead Sponsor: University of Giessen

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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-31
• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-01
• Study First Posted: 2022-01-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dentist-administered	Conventional Local Anaesthesia	-
Dentist-administered	Computer-controlled Local Anaesthesia (CCLA)	-
Student-administered	Conventional Local Anaesthesia	-
Student-administered	Computer-controlled Local Anaesthesia (CCLA)	-

Primary Outcome Measures

Name	Time	Method
Pain on Puncture (PoP)	Within 2 hours	Self-reported pain intensity on puncture using visual analogue scale (0 = no pain- 10 = the worse pain)
Pain during Delivery (PdD)	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 Outcome Measures

Name	Time	Method
Dental Anxiety (DA)	Within 2 hours	Assessed by the Dental Anxiety Scale (DAS)- Four questions survey with five possible answers. Each answer has a score: a = 1, b = 2, c = 3, d = 4, e = 5 Total possible = 20. Anxiety rating: 9 - 12 = moderate anxiety/ 13 - 14 = high anxiety/ 15 - 20 = severe anxiety

Trial Locations

Locations (1)

University of Giessen; 🇩🇪 Gießen, Hessen, Germany