Pain PerceptionNCT05192902
Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia
A study testing Conventional Local Anaesthesia in people with Pain Perception, run by University of Giessen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Perception
- What is being tested?
- Conventional Local Anaesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dental students at the Faculty of Medicine, University of Giessen enrolled in the course of Local Anaesthesia.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Computer-controlled Local Anaesthesia (CCLA), Conventional Local Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Conventional Local AnaesthesiaDevice
Conventional dental local anaesthetic injections.
| Study group | Role | What they receive |
|---|---|---|
| Student-administered | Experimental | Not described Receives: Device: Computer-controlled Local Anaesthesia (CCLA); Device: Conventional Local Anaesthesia |
| Dentist-administered | Placebo comparator | Not described Receives: Device: Computer-controlled Local Anaesthesia (CCLA); Device: Conventional Local Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on Puncture (PoP)
Self-reported pain intensity on puncture using visual analogue scale (0 = no pain- 10 = the worse pain)
Measured: 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)
Measured: Within 2 hours
Secondary outcomes (1)
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
Measured: Within 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Sep 2019
- Primary completion30 Jun 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Attia, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192902
- Sponsor's protocol ID
- CCLA
- Status last verified
- May 2024
- First submitted
- 14 Dec 2021
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception Following Computer-Controlled vs. Conventional Dental Anesthesia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05192902
- Acronym / sponsor ID
- CCLA
- Conditions
- Pain Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dental students at the Faculty of Medicine, University of Giessen enrolled in the course of Local Anaesthesia.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dentist-administered, Student-administered |
| Conventional Local AnaesthesiaConventional dental local anaesthetic injections. | Device | Dentist-administered, Student-administered |
Primary outcome
Pain on Puncture (PoP)
Time frame: Within 2 hours
Self-reported pain intensity on puncture using visual analogue scale (0 = no pain- 10 = the worse pain)
Pain during Delivery (PdD)
Time frame: Within 2 hours
Self-reported pain intensity during delivery of the anaesthetic solution sing visual analogue scale (0 = no pain- 10 = the worse pain)
1 secondary outcome
Dental Anxiety (DA)
Time frame: Within 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Local Anaesthesia in people with Pain Perception, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on Puncture (PoP) (time frame: Within 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.