Anesthetics, LocalNCT03839134
The Effectiveness of Soft Tissue Vibration in Reducing Pain of Local Anesthesia Injection in Adult Dental Patients
A study testing DentalVibe® Comfort Injection System and Lidocaine Epinephrine in people with Anesthetics, Local, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthetics, Local
- What is being tested?
- DentalVibe® Comfort Injection System and Lidocaine Epinephrine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Mar 2019to 5 Sep 2019
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status class I
- Planned for multiple dental treatments in the maxilla and mandible bilaterally
Who cannot join
- Patients <18 years old
- Pregnant ladies
- Smokers and alcoholics
- Patients on medications
- Drug abusers
- Never received dental treatment under local anesthesia before
- Patients with an acute infection with or without fever
- Patients with preoperative pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial.
The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).
- Conditions
- Anesthetics, Local
- Being tested
- DentalVibe® Comfort Injection System, Lidocaine Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DentalVibe® Comfort Injection SystemDevice
Also called DentalVibe
Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.
Lidocaine EpinephrineDrug
Also called Xylocaine 2% with Epinephrine
Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
| Study group | Role | What they receive |
|---|---|---|
| Pain of buccal injection with DentalVibe® | Experimental | DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection. Receives: Device: DentalVibe® Comfort Injection System; Drug: Lidocaine Epinephrine |
| Pain of buccal injection without DentalVibe® | Active comparator | Local anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. Receives: Drug: Lidocaine Epinephrine |
| Pain of palatal injection with DentalVibe® | Experimental | DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection. Receives: Device: DentalVibe® Comfort Injection System; Drug: Lidocaine Epinephrine |
| Pain of palatal injection without DentalVibe® | Active comparator | Local anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. Receives: Drug: Lidocaine Epinephrine |
| Pain of block injection with DentalVibe® | Experimental | DentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection. Receives: Device: DentalVibe® Comfort Injection System; Drug: Lidocaine Epinephrine |
| Pain of block injection without DentalVibe® | Active comparator | Local anesthesia (LA) injection for inferior alveolar nerve (IAN) block using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. Receives: Drug: Lidocaine Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain of needle penetration of buccal LA injection
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Measured: 1-2 seconds after mucosal penetration
Pain of anesthesia delivery during buccal LA infiltration
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Measured: 30 seconds after LA solution delivery
Pain of needle penetration of palatal LA injection
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Measured: 1-2 seconds after mucosal penetration
Pain of anesthesia delivery during palatal LA infiltration
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Measured: 30 seconds after LA solution delivery
Pain of needle penetration of IAN block LA injection
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Measured: 1-2 seconds after mucosal penetration
Pain of anesthesia delivery during IAN block LA injection
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Measured: 30 seconds after LA solution delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start20 Mar 2019
- Primary completion1 Aug 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetics, LocalStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ra'ed Salma, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Ra'ed G Salma, Principal investigator, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839134
- Sponsor's protocol ID
- FRP/2018/286
- Status last verified
- Sep 2019
- First submitted
- 30 Jan 2019
- Last updated
- 10 Sep 2019
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Automated Soft Tissue Vibration in Reducing Pain and Accelerating Action of Intraoral Local Anesthesia Injections in Adult Dental Patients. A Randomized Crossover Clinical Trial.
- ClinicalTrials.gov ID
- NCT03839134
- Acronym / sponsor ID
- FRP/2018/286
- Conditions
- Anesthetics, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 15 Feb 2019 (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.
The clinical trial will compare pain perception during dental local anesthesia injections with and without using soft tissue vibration device prior to injection. The primary goal is to test the effectiveness of such devices in pain/discomfort reduction during intraoral local anesthesia injections in various techniques (infiltration and block anesthesia).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pain of buccal injection with DentalVibe® | Experimental | Device: DentalVibe® Comfort Injection System, Drug: Lidocaine EpinephrineDentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) buccal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection. |
| Pain of buccal injection without DentalVibe® | Active comparator | Drug: Lidocaine EpinephrineLocal anesthesia (LA) for buccal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. |
| Pain of palatal injection with DentalVibe® | Experimental | Device: DentalVibe® Comfort Injection System, Drug: Lidocaine EpinephrineDentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) palatal injection. The LA to be used is Lidocaine 2% with Epinephrine dental injection. |
| Pain of palatal injection without DentalVibe® | Active comparator | Drug: Lidocaine EpinephrineLocal anesthesia (LA) for palatal infiltration using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. |
| Pain of block injection with DentalVibe® | Experimental | Device: DentalVibe® Comfort Injection System, Drug: Lidocaine EpinephrineDentalVibe® Comfort Injection System will be used prior and during the local anesthesia (LA) injection for inferior alveolar nerve (IAN) block. The LA to be used is Lidocaine 2% with Epinephrine dental injection. |
| Pain of block injection without DentalVibe® | Active comparator | Drug: Lidocaine EpinephrineLocal anesthesia (LA) injection for inferior alveolar nerve (IAN) block using Lidocaine Epinephrine dental injection. No tissue vibrations will be performed before or during the injection. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status class I
- Planned for multiple dental treatments in the maxilla and mandible bilaterally
Key exclusion criteria (8 listed)
- Patients <18 years old
- Pregnant ladies
- Smokers and alcoholics
- Patients on medications
- Drug abusers
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 |
|---|---|---|
| DentalVibe® Comfort Injection SystemAlso: DentalVibeSoft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection. | Device | Pain of block injection with DentalVibe®, Pain of buccal injection with DentalVibe®, Pain of palatal injection with DentalVibe® |
| Lidocaine EpinephrineAlso: Xylocaine 2% with EpinephrineDental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v). | Drug | Pain of block injection with DentalVibe®, Pain of block injection without DentalVibe®, Pain of buccal injection with DentalVibe®, Pain of buccal injection without DentalVibe®, Pain of palatal injection with DentalVibe®, Pain of palatal injection without DentalVibe® |
Primary outcome
Pain of needle penetration of buccal LA injection
Time frame: 1-2 seconds after mucosal penetration
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of anesthesia delivery during buccal LA infiltration
Time frame: 30 seconds after LA solution delivery
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of needle penetration of palatal LA injection
Time frame: 1-2 seconds after mucosal penetration
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of anesthesia delivery during palatal LA infiltration
Time frame: 30 seconds after LA solution delivery
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of needle penetration of IAN block LA injection
Time frame: 1-2 seconds after mucosal penetration
The pain of needle penetration will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
Pain of anesthesia delivery during IAN block LA injection
Time frame: 30 seconds after LA solution delivery
The pain during anesthesia solution delivery will be assessed using 10-point Graphic Rating Scale (GRS). The pain score will be compared to its counterpart pain score on the experimental side using DentalVibe® injection system.
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 10 Sep 2019.
- 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.
Ra'ed G Salma principal investigator
Riyadh Elm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DentalVibe® Comfort Injection System and Lidocaine Epinephrine in people with Anesthetics, Local, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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 2 inclusion and 8 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 10 Sep 2019. 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 Saudi Arabia. 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. 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 of needle penetration of buccal LA injection (time frame: 1-2 seconds after mucosal penetration). The study lists 6 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 10 Sep 2019.