NCT05192902

Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain Perception

Interventions

Type	Name	Description
DEVICE	Computer-controlled Local Anaesthesia (CCLA)	The computer-controlled local anesthetic injector Calaject®, (Rønvig Dental MFG, Daugaard, Denmark), which is designed to reduce the pain of performing local anaesthesia. The principle of this device is based on the fact that the less pressure and flow of a local anaesthetic injection, the less painful will be the procedure. Each device has an installed pressure sensor as well as a three-button display that allows choosing the most appropriate program in terms of different speeds and pressure. According to the anaesthesia technique, the manufacture recommends program I for intraligamentary and palatally injections, program II for infiltration and III for alveolar nerve block techniques. Conventional carpules and needles can be used in a pen-shaped part connecting to the main unit. The administration of the anaesthetic can be achieved using a foot control pedal which is adapted to the main unit, the speed of injection is related to acoustic signals.
DEVICE	Conventional Local Anaesthesia	Conventional dental local anaesthetic injections.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-06-30
• Completion: 2020-12-31
• First posted: 2022-01-14
• Last updated: 2024-05-13

Locations

1 site across 1 country: Germany