PainNCT03374982
Effect of the DentalVibe Injection System on Pain During Local Anesthesia Injections in Children
A study testing DentalVibe in people with Pain, run by University of Nebraska at 1 site in United States.
Trial summary
Title: Effect of the DentalVibe injection system on pain during local anesthesia injections in children. Purpose: The purpose of this study is to compare self-reported pain scale measurements using the Wong-Baker FACES pain rating scale from an experimental group (local anesthesia injection with DentalVibe system) and… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Pain
- What is being tested?
- DentalVibe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 20 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 5-11 who require dental treatment that requires bilateral local anesthesia on the maxilla or mandible. Subjects must understand and speak English.
Who cannot join
- No children with presence of medically or developmentally compromising conditions (autism, cerebral palsy, moderate/severe asthma); history of chronic disease (seizure disorder, cardiac disorder, hematological disease, endocrine disorder, liver disease, renal disease). Non-English speakers will be excluded. Subject who require oral sedation or general anesthesia for treatment due to behavior or medical history will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital & Medical Center Specialty Pediatric Center Dental Clinic
Omaha, Nebraska, 68114
About this study
Official title: Effect of the DentalVibe Injections System on Pain During Local Anesthesia Injections in Children
Title: Effect of the DentalVibe injection system on pain during local anesthesia injections in children.
Purpose: The purpose of this study is to compare self-reported pain scale measurements using the Wong-Baker FACES pain rating scale from an experimental group (local anesthesia injection with DentalVibe system) and a control group (traditional local anesthesia injection with DentalVibe system turned off) in children.
Read more
Eligibility: Children age 5-11 years old who require local anesthesia for bilateral dental treatment at University of Nebraska Medical Center (UNMC) pediatric dental clinic. Children must understand and speak English.
Interventions and evaluations: Each patient will have two separate restorative appointments where the DentalVibe will be used during local anesthetic injections. One appointment the DentalVibe will be turned on and one appointment the DentalVibe will be turned off. After each injection the child will be shown the Wong Baker FACES Pain Rating Scale and asked to pick a face associated with their level of hurt during the injection.
Follow-up: All children will be followed up with any necessary recommended dental treatment.
Read the detailed description
Up to 50 children between the ages of 5-11 years will participate in this randomized, controlled, cross-over, split-mouth study. There will be no gender restrictions used in this study. Participants will be recruited from a continuous sample of patient seen at the UNMC pediatric dental clinic and will be selected based on their need for dental treatment. Each child will have 2 separate dental appointments.
Written consent will be obtained from parent or guardian prior to first restorative appointment. Verbal consent will be obtained prior to second restorative appointment.
Dr. Marshall will be the provider for every patient. The same dental assistant will be used for each appointment. All treatment will be completed in the same private quiet room. Both Dr. Marshall and the dental assistant will wear the same color scrubs and black lab jackets during all appointments.
One appointment patient will receive local anesthetic dental injection with the DentalVibe turned on and at one appointment the child will receive local anesthetic dental injection with the DentalVibe off. Used strictly as a check/lip retractor. The child will be randomly assigned via a random number generator to either the DentalVibe on or off during the initial appointment. During the DentalVibe turned on appointment, the DentalVibe will be introduced to each child to make him/her familiar with the vibration sensation.
All patients will receive 5 mins of O2, then nitrous oxide (N2O) will be titrated up to 50%N2O/50%O2. When appointment is complete the child will receive 5 mins of 100% O2.
At both restorative appointment a cotton tip applicator with 20% Benzocaine topical anesthetic gel (Patterson) will be administered for 1 min. 2% Lidocaine hydrochloride (HCl) with 1:100,000epinepherine (Patterson Dental) will the be deposited using a medium-length (0.4mm) with 27-gauge short needles. Local anesthetic injections will be referred to as "sleepy juice." Buccal and lingual infiltration will perform on the maxilla. Mandibular blocks will be performed on the mandible. One cartridge of local anesthetic will be used at each appointment. After administration, patient will be shown the Wong Baker FACES pain rating scale and asked to rate the amount of discomfort experienced during the injection by pointing to the face or number. The following manuscript will be used:
"Each face represents a person who has no hurt, or some hurt, or a lot of hurt." "Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain." "Touch the face of the hurt you felt when I gave you the sleepy juice."
After child has rated pain Dr. Marshall will continue with restorative treatment. The same process will be followed at the second appointment. Appointments will be scheduled 3-4 weeks apart.
- Conditions
- Pain
- Being tested
- DentalVibe
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DentalVibeDevice
The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.
| Study group | Role | What they receive |
|---|---|---|
| DentalVibe turned On then turned Off | Experimental | DentalVibe will be turned on during local anesthetic injection at the first appointment. DentalVibe will be turned off during local anesthetic injection at the second appointment. Receives: Device: DentalVibe |
| DentalVibe turned Off and then turned On | Experimental | DentalVibe will be turned off during local anesthetic injection at the first appointment. DentalVibe will be turned on during local anesthetic injection at the second appointment. Receives: Device: DentalVibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported Pain Rating Using Wong-Baker FACES Scale
The scale includes pictures of facial expressions with correlating numerical scale of 0-10. 0 being no hurt and 10 being the worst hurt.
Measured: Immediately after local anesthetic delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start19 Feb 2018
- Primary completion3 Apr 2018
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized cross-over clinical trial wherein the study subject serves as his or her own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher H Johnson, DDS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374982
- Sponsor's protocol ID
- 0661-17-FB
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2017
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the DentalVibe Injections System on Pain During Local Anesthesia Injections in Children
- ClinicalTrials.gov ID
- NCT03374982
- Acronym / sponsor ID
- 0661-17-FB
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 3 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Title: Effect of the DentalVibe injection system on pain during local anesthesia injections in children.
Purpose: The purpose of this study is to compare self-reported pain scale measurements using the Wong-Baker FACES pain rating scale from an experimental group (local anesthesia injection with DentalVibe system) and a control group (traditional local anesthesia injection with DentalVibe system turned off) in children.
Eligibility: Children age 5-11 years old who require local anesthesia for bilateral dental treatment at University of Nebraska Medical Center (UNMC) pediatric dental clinic. Children must understand and speak English.
Interventions and evaluations: Each patient will have two separate restorative appointments where the DentalVibe will be used during local anesthetic injections. One appointment the DentalVibe will be turned on and one appointment the DentalVibe will be turned off. After each injection the child will be shown the Wong Baker FACES Pain Rating Scale and asked to pick a face associated with their level of hurt during the injection.
Follow-up: All children will be followed up with any necessary recommended dental treatment.
Detailed description
Up to 50 children between the ages of 5-11 years will participate in this randomized, controlled, cross-over, split-mouth study. There will be no gender restrictions used in this study. Participants will be recruited from a continuous sample of patient seen at the UNMC pediatric dental clinic and will be selected based on their need for dental treatment. Each child will have 2 separate dental appointments.
Written consent will be obtained from parent or guardian prior to first restorative appointment. Verbal consent will be obtained prior to second restorative appointment.
Dr. Marshall will be the provider for every patient. The same dental assistant will be used for each appointment. All treatment will be completed in the same private quiet room. Both Dr. Marshall and the dental assistant will wear the same color scrubs and black lab jackets during all appointments.
One appointment patient will receive local anesthetic dental injection with the DentalVibe turned on and at one appointment the child will receive local anesthetic dental injection with the DentalVibe off. Used strictly as a check/lip retractor. The child will be randomly assigned via a random number generator to either the DentalVibe on or off during the initial appointment. During the DentalVibe turned on appointment, the DentalVibe will be introduced to each child to make him/her familiar with the vibration sensation.
All patients will receive 5 mins of O2, then nitrous oxide (N2O) will be titrated up to 50%N2O/50%O2. When appointment is complete the child will receive 5 mins of 100% O2.
At both restorative appointment a cotton tip applicator with 20% Benzocaine topical anesthetic gel (Patterson) will be administered for 1 min. 2% Lidocaine hydrochloride (HCl) with 1:100,000epinepherine (Patterson Dental) will the be deposited using a medium-length (0.4mm) with 27-gauge short needles. Local anesthetic injections will be referred to as "sleepy juice." Buccal and lingual infiltration will perform on the maxilla. Mandibular blocks will be performed on the mandible. One cartridge of local anesthetic will be used at each appointment. After administration, patient will be shown the Wong Baker FACES pain rating scale and asked to rate the amount of discomfort experienced during the injection by pointing to the face or number. The following manuscript will be used:
"Each face represents a person who has no hurt, or some hurt, or a lot of hurt." "Face 0 doesn't hurt at all. Face 2 hurts just a little bit. Face 4 hurts a little bit more. Face 6 hurts even more. Face 8 hurts a whole lot. Face 10 hurts as much as you can imagine, although you don't have to be crying to have this worst pain." "Touch the face of the hurt you felt when I gave you the sleepy juice."
After child has rated pain Dr. Marshall will continue with restorative treatment. The same process will be followed at the second appointment. Appointments will be scheduled 3-4 weeks apart.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized cross-over clinical trial wherein the study subject serves as his or her own control.
| Arm | Type | Receives |
|---|---|---|
| DentalVibe turned On then turned Off | Experimental | Device: DentalVibeDentalVibe will be turned on during local anesthetic injection at the first appointment. DentalVibe will be turned off during local anesthetic injection at the second appointment. |
| DentalVibe turned Off and then turned On | Experimental | Device: DentalVibeDentalVibe will be turned off during local anesthetic injection at the first appointment. DentalVibe will be turned on during local anesthetic injection at the second appointment. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 5-11 who require dental treatment that requires bilateral local anesthesia on the maxilla or mandible. Subjects must understand and speak English.
Key exclusion criteria (1 listed)
- No children with presence of medically or developmentally compromising conditions (autism, cerebral palsy, moderate/severe asthma); history of chronic disease (seizure disorder, cardiac disorder, hematological disease, endocrine disorder, liver disease, renal disease). Non-English speakers will be excluded. Subject who require oral sedation or general anesthesia for treatment due to behavior or medical history will be excluded.
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 |
|---|---|---|
| DentalVibeThe DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration. | Device | DentalVibe turned Off and then turned On, DentalVibe turned On then turned Off |
Primary outcome
Self Reported Pain Rating Using Wong-Baker FACES Scale
Time frame: Immediately after local anesthetic delivery
The scale includes pictures of facial expressions with correlating numerical scale of 0-10. 0 being no hurt and 10 being the worst hurt.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Christopher H Johnson, DDS principal investigator
University of Nebraska
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 in people with Pain, run by University of Nebraska at 1 site in United States.
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 1 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 3 Jan 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 United States. 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?
Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self Reported Pain Rating Using Wong-Baker FACES Scale (time frame: Immediately after local anesthetic delivery). 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 3 Jan 2024.