Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Perception
• Intervention / Treatment: Device: Computer-controlled Local Anaesthesia (CCLA); Device: Conventional Local Anaesthesia

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Gießen, Hessen, Germany
      • University of Giessen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Student-administered	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.
Placebo Comparator: Dentist-administered	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on Puncture (PoP)	Self-reported pain intensity on puncture using visual analogue scale (0 = no pain- 10 = the worse pain)	Within 2 hours
Pain during Delivery (PdD)	Self-reported pain intensity during delivery of the anaesthetic solution sing visual analogue scale (0 = no pain- 10 = the worse pain)	Within 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Anxiety (DA)	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	Within 2 hours

Collaborators and Investigators

• Sponsor: University of Giessen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 1, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CCLA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No