Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia

NCT05192902 | Completed

• 1 other identifier: CCLA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Perception

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Dental Anxiety (DA)

  Within 2 hours

Study Arms (2)

Student-administered

EXPERIMENTAL

Device: Computer-controlled Local Anaesthesia (CCLA); Device: Conventional Local Anaesthesia

Dentist-administered

PLACEBO COMPARATOR

Device: Computer-controlled Local Anaesthesia (CCLA); Device: Conventional Local Anaesthesia

Interventions

Computer-controlled Local Anaesthesia (CCLA) DEVICE

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.

Dentist-administered; Student-administered

Conventional Local Anaesthesia DEVICE

Conventional dental local anaesthetic injections.

Dentist-administered; Student-administered

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University of Giessen

Giessen, Hesse, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Dental Polyclinic

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 14, 2022
• Study Start: September 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)