Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia

• Sponsor: University of Giessen (Other)
• Overall Status: Completed
• CT.gov ID: NCT05192902
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 16
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Perception	Device: Computer-controlled Local Anaesthesia (CCLA); Device: Conventional Local Anaesthesia	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia: Randomized Controlled Trial
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pain on Puncture (PoP) [Within 2 hours]

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

2. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Giessen	Gießen	Hessen	Germany

Sponsors and Collaborators

• University of Giessen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sameh Attia, Head of the Dental Polyclinic, University of Giessen
• ClinicalTrials.gov Identifier: NCT05192902
• Other Study ID Numbers: CCLA
• First Posted: Jan 14, 2022
• Last Update Posted: Jan 14, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Anesthetics

Study Results

No Results Posted as of Jan 14, 2022