Pain ManagementNCT03445182
Effectiveness of DentalVibe in Reducing Injection Pain and Anxiety During Local Anaesthesia in Children
A study testing Local anaesthesia with conventional syringe and Local anaesthesia with conventional syringe + Dentalvibe in people with Pain Management and Local Anaesthesia, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial summary
The aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing injection pain and anxiety associated with local anaesthesia in paediatric patients. The clinical trial is a randomized split-mouth assignment. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Local Anaesthesia
- What is being tested?
- Local anaesthesia with conventional syringe and Local anaesthesia with conventional syringe + Dentalvibe
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Apr 2018to 10 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- Children, requiring local anaesthesia infiltration for extraction of two primary upper jaw molars bilaterally.
- Indications for extraction of primary molars: over-retention - in case of delayed physiological change and tendency of eruption of the permanent tooth; orthodontic reasons - tooth removed to prevent or correct malocclusion; advanced root resorption and imminent physiological tooth replacement; teeth with a severely damaged clinical crown (from trauma or caries and its complications); teeth with failed pulpotomy, acute or chronic diffuse periodontitis, endangering the germ of the permanent tooth.
- Obtained informed consent from parents or gave-givers to participate in the study.
Who cannot join
- Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events.
- Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- Patients with allergy to local anesthetics of the amide group.
- Children, who are first time ever dental patients.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Faculty of Dental Medicine, Medical University - Plovdiv
Plovdiv, 4000
About this study
Official title: Effectiveness of DentalVibe Comfort System in Reducing Injection Pain and Anxiety During Local Anaesthesia in Paediatric Patients
The aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing injection pain and anxiety associated with local anaesthesia in paediatric patients.
The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for extraction of two primary maxillary molars bilaterally. Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, where as DV is allocated to either first or second local anaesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on VAS. Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anaesthesia method - CS or CS+DV.
Read the detailed description
Achieving local anaesthesia in children is one of the critical aspects of pain management.
In recent years, several innovative dental appliances have been developed on the concept to reduce the pain of needle injection by applying pressure, vibration, microoscillations or a combination of them.
Тhe aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing injection pain and anxiety associated with local anaesthesia in paediatric patients.
The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 8-12 years old requiring local anesthetic infiltration for extraction of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after CFSS-DS measurement of dental fear prior to each. Local anaethetic is delivered through buccal infiltration with conventional syringe, where as DentalVibe Comfort System Injection is allocated to either first or second local anaesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anaesthesia method - traditional infiltration or DentalVibe-assisted injection.
- Conditions
- Pain Management, Local Anaesthesia
- Being tested
- Local anaesthesia with conventional syringe, Local anaesthesia with conventional syringe + Dentalvibe
- Keywords
- pain control, paediatric dental patients, local anaesthesia, dentalvibe
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anaesthesia with conventional syringeProcedure or surgery
Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
Local anaesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL
Local anaesthesia with conventional syringe + DentalvibeDevice
Buccal infiltration in posterior maxillary region. The tip of the DentalVibe device is placed in the mucobuccal fold above the tooth to be anesthetized. The device is activated for 5 s. A 27 gauge short needle is inserted as close as possible to the inner side of the prong while the vibration is still on.
Local anaesthetic infiltration speed 1ml/min. After injection the needle is withdrawn and vibration continues for another 5 s.
Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Local anaesthesia with conventional syringe Receives: Procedure: Local anaesthesia with conventional syringe |
| DentalVibe group | Active comparator | Local anaesthesia with conventional syringe + DentalVibe Receives: Device: Local anaesthesia with conventional syringe + Dentalvibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain felt during injection using visual analogue scale
Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
Measured: Immediately after local anaesthetic delivery
Secondary outcomes (5)
Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
Evaluated by the outcomes assessor. The FLACC scale has five criteria - Faces, Legs, Activity, Cry, Consolability, which are each assigned a score of 0, 1 or 2. Total score of scale is summed in range 0 to 10, where: 0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
Measured: During local anaesthesia procedure
Self-reported anxiety during injection evaluated on FIS
The Facial Image Scale (FIS) comprises a row of five faces from very unhappy (score 5) to very happy (score 1).
Measured: Immediately after local anaesthetic delivery
Heart rate dynamics of the patient
Patient's left index finger is connected to a portable recording pulse oximeter for children.
Measured: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
Assessment of self-reported dental fear on CFSS-DS questionnaire
Assessment will be performed prior to both visits. The Children's Fear Survey Schedule - Dental Subscale (CFSS-DS) questionnaire consists of 15 items related to different aspects of dental treatment, including fear of injections, scored as follows: Not afraid = 1; a little afraid = 2; fairly afraid = 3; quite afraid = 4; and very afraid = 5. Total score: 15 to 75. Children with CFSS-DS ≥32 are defined as dentally anxious.
Measured: Prior to each visit
Patient preference to local anaesthesia method
One week after the second dental visit, the patient is reached by a phone call and asked: "Which method do you prefer to put your tooth to sleep? With the vibrating device or without it?"
Measured: One week after second procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Apr 2018
- Primary completion10 Jun 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Crossover
- Model description
- Randomized Intervention Model: Split-mouth assignment
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ani Beltcheva, Study director, Medical University - Plovdiv, Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445182
- Sponsor's protocol ID
- PlovdivMU1
- Status last verified
- Jun 2021
- First submitted
- 20 Feb 2018
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Veneva E, Cholakova R, Raycheva R, Belcheva A. Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial. BMJ Open. 2019 Jul 2;9(7):e029460. doi: 10.1136/bmjopen-2019-029460.
PubMed 31270121
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of DentalVibe Comfort System in Reducing Injection Pain and Anxiety During Local Anaesthesia in Paediatric Patients
- ClinicalTrials.gov ID
- NCT03445182
- Acronym / sponsor ID
- PlovdivMU1
- Conditions
- Pain Management, Local Anaesthesia
- Keywords
- pain control, paediatric dental patients, local anaesthesia, dentalvibe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 26 Feb 2018 (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 aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing injection pain and anxiety associated with local anaesthesia in paediatric patients.
The clinical trial is a randomized split-mouth assignment. Included patients are 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for extraction of two primary maxillary molars bilaterally. Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, where as DV is allocated to either first or second local anaesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on VAS. Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anaesthesia method - CS or CS+DV.
Detailed description
Achieving local anaesthesia in children is one of the critical aspects of pain management.
In recent years, several innovative dental appliances have been developed on the concept to reduce the pain of needle injection by applying pressure, vibration, microoscillations or a combination of them.
Тhe aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing injection pain and anxiety associated with local anaesthesia in paediatric patients.
The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 8-12 years old requiring local anesthetic infiltration for extraction of two primary maxillary molars bilaterally.
Eligible patients undergo two single-visit treatments after CFSS-DS measurement of dental fear prior to each. Local anaethetic is delivered through buccal infiltration with conventional syringe, where as DentalVibe Comfort System Injection is allocated to either first or second local anaesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on visual analogue scale. Secondary outcome measures: self-reported anxiety during injection on Facial Image Scale; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anaesthesia method - traditional infiltration or DentalVibe-assisted injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Intervention Model: Split-mouth assignment
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Local anaesthesia with conventional syringeLocal anaesthesia with conventional syringe |
| DentalVibe group | Active comparator | Device: Local anaesthesia with conventional syringe + DentalvibeLocal anaesthesia with conventional syringe + DentalVibe |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
- Children, requiring local anaesthesia infiltration for extraction of two primary upper jaw molars bilaterally.
- Indications for extraction of primary molars: over-retention - in case of delayed physiological change and tendency of eruption of the permanent tooth; orthodontic reasons - tooth removed to prevent or correct malocclusion; advanced root resorption and imminent physiological tooth replacement; teeth with a severely damaged clinical crown (from trauma or caries and its complications); teeth with failed pulpotomy, acute or chronic diffuse periodontitis, endangering the germ of the permanent tooth.
- Obtained informed consent from parents or gave-givers to participate in the study.
Key exclusion criteria (4 listed)
- Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events.
- Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
- Patients with allergy to local anesthetics of the amide group.
- Children, who are first time ever dental patients.
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 |
|---|---|---|
| Local anaesthesia with conventional syringeBuccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized. Local anaesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL | Procedure or surgery | Control group |
| Local anaesthesia with conventional syringe + DentalvibeBuccal infiltration in posterior maxillary region. The tip of the DentalVibe device is placed in the mucobuccal fold above the tooth to be anesthetized. The device is activated for 5 s. A 27 gauge short needle is inserted as close as possible to the inner side of the prong while the vibration is still on. Local anaesthetic infiltration speed 1ml/min. After injection the needle is withdrawn and vibration continues for another 5 s. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL | Device | DentalVibe group |
Primary outcome
Pain felt during injection using visual analogue scale
Time frame: Immediately after local anaesthetic delivery
Self-reported pain by the patient immediately after local anaesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.
5 secondary outcomes
Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale
Time frame: During local anaesthesia procedure
Self-reported anxiety during injection evaluated on FIS
Time frame: Immediately after local anaesthetic delivery
Heart rate dynamics of the patient
Time frame: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.
Assessment of self-reported dental fear on CFSS-DS questionnaire
Time frame: Prior to each visit
Patient preference to local anaesthesia method
Time frame: One week after second procedure
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 4 Jun 2021.
- Derived from this study: PubMed 31270121Veneva E, Cholakova R, Raycheva R, Belcheva A. Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial. BMJ Open. 2019 Jul 2;9(7):e029460. doi: 10.1136/bmjopen-2019-029460.
- 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.
Ani Beltcheva study director
Medical University - Plovdiv, Bulgaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anaesthesia with conventional syringe and Local anaesthesia with conventional syringe + Dentalvibe in people with Pain Management and Local Anaesthesia, run by Plovdiv Medical University at 1 site in Bulgaria.
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 4 inclusion and 4 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 4 Jun 2021. 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 Bulgaria. 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 felt during injection using visual analogue scale (time frame: Immediately after local anaesthetic delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445182, which also lists 1 linked publication.
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 4 Jun 2021.