Pediatric DentistryNCT03176446
Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment
A study testing Local anesthesia with traditional technique, Local anesthesia with computerized technique and Local anesthesia with DentalVibe technique in people with Pediatric Dentistry and Local Anesthesia, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
Trial summary
Fear and dental anxiety are often associated with the use of needles and syringes for local anesthesia, and painful perception during the administration of local anesthetics is often the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in childhood, through experience misconduct. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Dentistry, Local Anesthesia, Pain Management
- What is being tested?
- Local anesthesia with traditional technique, Local anesthesia with computerized technique and Local anesthesia with DentalVibe technique
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2017to 1 Mar 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of both sexes, aged between 5 and 12 years, requiring dental treatment under local anesthesia in the first permanent molars or deciduous maxilla.
Who cannot join
- The person responsible does not authorize the participation of the child as a research volunteer.
- Be using pain modulating drugs.
- Be using anxiety modulating drugs.
- Patients with a history of hypersensitivity to local anesthetics.
- Patients with a history of systemic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Fear and dental anxiety are often associated with the use of needles and syringes for local anesthesia, and painful perception during the administration of local anesthetics is often the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in childhood, through experience misconduct. The objective of this study is to evaluate the pain and anxiety related to 4 different modalities of anesthesia in children. Will be selected volunteers aged between 5 and 12 years who need restorative dental treatment in posterior teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia: conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological and behavioral criteria. For the physiological evaluation will be measured the blood pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong Baker Faces. The results will be submitted to parametric and non-parametric statistical analysis, according to the data obtained in the different evaluation criteria.
- Conditions
- Pediatric Dentistry, Local Anesthesia, Pain Management
- Being tested
- Local anesthesia with traditional technique, Local anesthesia with computerized technique, Local anesthesia with DentalVibe technique, Topic anesthesia, Local anesthetic
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthesia with traditional techniqueDevice
Also called Traditional anesthesia, Conventional anesthesia
Puncture with short needle in the region of the apical third of the tooth to be anesthetized Injection of local anesthetic, with speed 1ml / min
Local anesthesia with computerized techniqueDevice
Also called Computerized anesthesia
Puncture with short needle in the region of the apical third of the tooth to be anesthetized according to the recommendations of the manufacturer Injection of local anesthetic with computerized anesthesia equipment, with speed 0.5 ml / min
Local anesthesia with DentalVibe techniqueDevice
Also called DentalVibe anesthesia
Use of DentalVibe in the apical region of the tooth to be anesthetized according to the manufacturer's guidelines Puncture with short needle enters the tips of the DentalVibe Injection of local anesthetic with traditional carpule, with speed 1 ml / min
Topic anesthesiaDrug
Also called Topical anesthesia
Application of topical anesthetic for 60 seconds with benzocaine
Local anestheticDrug
Also called Anesthetic
2% lidocaine with epinephrine 1: 100000 1.8 mL
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The children anesthesia will be traditional technique Receives: Device: Local anesthesia with traditional technique; Drug: Topic anesthesia; Drug: Local anesthetic |
| Computerized Group | Active comparator | The children anesthesia will be computerized technique Receives: Device: Local anesthesia with computerized technique; Drug: Topic anesthesia; Drug: Local anesthetic |
| DentalVibe Group | Active comparator | The children anesthesia will be DentalVibe technique Receives: Device: Local anesthesia with DentalVibe technique; Drug: Topic anesthesia; Drug: Local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-perception of pain
The pain will be analyzed by the Wong Baker Faces scales
Measured: Immediately after anesthesia
Pain Behavior
The pain will be analyzed by the FLACC
Measured: During the anesthetic procedure
Self-perception of pain
The pain will be analyzed by the Visual Analogue Scale (0-10). 0- no pain, 10- severe pain
Measured: Immediately after anesthesia
Secondary outcomes (8)
SCARED Questionnaire
Children will be evaluated for the anxiety behavior prior to any anesthesia by answering the SCARED questionnaire
Measured: Before anesthesia
Corah Questionnaire
Children will be evaluated for the dentistry anxiety prior to any anesthesia
Measured: Before anethesia
VPT modified
Children will be evaluated for the anxiety after to any anesthesia
Measured: Before anethesia and immediately after anesthesia
Blood pressure
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of blood pressure
Measured: Immediately before anesthesia, during anesthesia
Respiratory rate
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of respiratory rate
Measured: Immediately before anesthesia, during anesthesia
Heart rate
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of heart rate
Measured: Immediately before anesthesia, during anesthesia
Oxygen saturation
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of oxygen saturation
Measured: Immediately before anesthesia, during anesthesia
Salivary cortisol
The physiological response of anxiety to local dental anesthesia will be evaluated by parameters of salivary cortisol
Measured: Immediately before anesthesia, during anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Oct 2017
- Primary completion30 Nov 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DentistryStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The total sample is divided into two subgroups, with 105 children aged 5 to 8 years and 105 children aged 9 to 12 years. The analysis is more sensitive and specific to each subgroup. The results of each subgroup will be analyzed in isolation and give rise to two different papers.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Ponta Grossa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscila de Camargo Smolarek, Universidade Estadual de Ponta Grossa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176446
- Sponsor's protocol ID
- 64773417.3.0000.5689
- Status last verified
- Apr 2020
- First submitted
- 12 May 2017
- Last updated
- 30 Apr 2020
- Results posted
- 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 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment
- ClinicalTrials.gov ID
- NCT03176446
- Acronym / sponsor ID
- 64773417.3.0000.5689
- Conditions
- Pediatric Dentistry, Local Anesthesia, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Universidade Estadual de Ponta GrossaUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Jun 2017 (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.
Fear and dental anxiety are often associated with the use of needles and syringes for local anesthesia, and painful perception during the administration of local anesthetics is often the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in childhood, through experience misconduct. The objective of this study is to evaluate the pain and anxiety related to 4 different modalities of anesthesia in children. Will be selected volunteers aged between 5 and 12 years who need restorative dental treatment in posterior teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia: conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological and behavioral criteria. For the physiological evaluation will be measured the blood pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong Baker Faces. The results will be submitted to parametric and non-parametric statistical analysis, according to the data obtained in the different evaluation criteria.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The total sample is divided into two subgroups, with 105 children aged 5 to 8 years and 105 children aged 9 to 12 years. The analysis is more sensitive and specific to each subgroup. The results of each subgroup will be analyzed in isolation and give rise to two different papers.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Local anesthesia with traditional technique, Drug: Topic anesthesia, Drug: Local anestheticThe children anesthesia will be traditional technique |
| Computerized Group | Active comparator | Device: Local anesthesia with computerized technique, Drug: Topic anesthesia, Drug: Local anestheticThe children anesthesia will be computerized technique |
| DentalVibe Group | Active comparator | Device: Local anesthesia with DentalVibe technique, Drug: Topic anesthesia, Drug: Local anestheticThe children anesthesia will be DentalVibe technique |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of both sexes, aged between 5 and 12 years, requiring dental treatment under local anesthesia in the first permanent molars or deciduous maxilla.
Key exclusion criteria (5 listed)
- The person responsible does not authorize the participation of the child as a research volunteer.
- Be using pain modulating drugs.
- Be using anxiety modulating drugs.
- Patients with a history of hypersensitivity to local anesthetics.
- Patients with a history of systemic diseases.
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 anesthesia with traditional techniqueAlso: Traditional anesthesia, Conventional anesthesiaPuncture with short needle in the region of the apical third of the tooth to be anesthetized Injection of local anesthetic, with speed 1ml / min | Device | Control Group |
| Local anesthesia with computerized techniqueAlso: Computerized anesthesiaPuncture with short needle in the region of the apical third of the tooth to be anesthetized according to the recommendations of the manufacturer Injection of local anesthetic with computerized anesthesia equipment, with speed 0.5 ml / min | Device | Computerized Group |
| Local anesthesia with DentalVibe techniqueAlso: DentalVibe anesthesiaUse of DentalVibe in the apical region of the tooth to be anesthetized according to the manufacturer's guidelines Puncture with short needle enters the tips of the DentalVibe Injection of local anesthetic with traditional carpule, with speed 1 ml / min | Device | DentalVibe Group |
| Topic anesthesiaAlso: Topical anesthesiaApplication of topical anesthetic for 60 seconds with benzocaine | Drug | Computerized Group, Control Group, DentalVibe Group |
| Local anestheticAlso: Anesthetic2% lidocaine with epinephrine 1: 100000 1.8 mL | Drug | Computerized Group, Control Group, DentalVibe Group |
Primary outcome
Self-perception of pain
Time frame: Immediately after anesthesia
The pain will be analyzed by the Wong Baker Faces scales
Pain Behavior
Time frame: During the anesthetic procedure
The pain will be analyzed by the FLACC
Self-perception of pain
Time frame: Immediately after anesthesia
The pain will be analyzed by the Visual Analogue Scale (0-10). 0- no pain, 10- severe pain
8 secondary outcomes
SCARED Questionnaire
Time frame: Before anesthesia
Corah Questionnaire
Time frame: Before anethesia
VPT modified
Time frame: Before anethesia and immediately after anesthesia
Blood pressure
Time frame: Immediately before anesthesia, during anesthesia
Respiratory rate
Time frame: Immediately before anesthesia, during anesthesia
Heart rate
Time frame: Immediately before anesthesia, during anesthesia
Oxygen saturation
Time frame: Immediately before anesthesia, during anesthesia
Salivary cortisol
Time frame: Immediately before anesthesia, during anesthesia
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 30 Apr 2020.
- 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 Local anesthesia with traditional technique, Local anesthesia with computerized technique and Local anesthesia with DentalVibe technique in people with Pediatric Dentistry and Local Anesthesia, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
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 5 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 30 Apr 2020. 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 Brazil. 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?
Self-perception of pain (time frame: Immediately after anesthesia). The study lists 3 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 30 Apr 2020.