Anesthesia, DentalPhase 4NCT03318952
Articaine vs Lidocaine for Pediatric Dental Procedures
A Phase 4 study testing lidocaine and articaine in people with Anesthesia, Dental and Pain, Postoperative, run by Boston University at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of two types of local anesthesia (articaine and lidocaine) for infiltration anesthesia during restorative dental procedures on lower teeth in pediatric patients. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Anesthesia, Dental, Pain, Postoperative
- What is being tested?
- lidocaine and articaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2022to Jun 2023
- Phase
- Phase 4
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients receiving dental care at Boston Medical Center Pediatric Dental Clinic, Boston University Pediatric Oral Health Center, and East Boston Neighborhood Health Center Pediatric Dental Clinic
- Patients needing similar restorative dental procedures to primary molar teeth on both sides of the maxillary arch or upper arch
- Boys and girls between ages 4 to 14 years
- English speaking and be able to understand verbal assent.
Who cannot join
- Patients for whom the use of articaine is contraindicated such as patients with Acetylcholine esterase deficiency
- Patients for whom the use of lidocaine is contraindicated in patients taking metronidazole
Trial locations and contacts
1 site in 1 country.
United States1 site
BU Henry M. Goldman School of Dental Medicine
Boston, Massachusetts, 02118
About this study
Official title: Efficacy of Articaine vs. Lidocaine When Used for Local Infiltration in Pediatric Dental Procedures
The purpose of this study is to compare the efficacy of two types of local anesthesia (articaine and lidocaine) for infiltration anesthesia during restorative dental procedures on lower teeth in pediatric patients. The patients will require similar dental operative procedures on both right and left sides of the mandible in order to qualify for this study. The study will require at least two dental appointments, where a randomized, cross-over study methodology will be utilized. All subjects will be treated by the same dentist. The comfort of the patient will be assessed at various points during the procedure using the Wong-Baker Faces Scale.
Read the detailed description
This study will compare articaine to lidocaine with overall quality of anesthesia. When administering lidocaine, the investigator will follow standard of care by administering a buccal infiltration injection followed by 2-3 interpapillary injections, one at each gingival papilla where the rubber dam clamp will be placed and possibly more if needed in areas where dental treatment will be provided. A single buccal infiltration injection of articaine will be administered, with the hypothesis that articaine is a stronger anesthestic and will deliver palatal anesthesia with a single injection, eliminating the interpapillary injections required for lidocaine to achieve adequate soft tissue anesthesia. The comfort of the patient during multiple steps of the dental treatment will be recorded. A randomized, cross-over methodology will be used. This study seeks to find whether adequate anesthesia in the mandible can be achieved with a single injection of articaine in the buccal aspect of the jaw instead of having to administer multiple injections of lidocaine, which can increase patient anxiety and discomfort. By decreasing the number of injections needed for children during dental treatment while providing adequate local anesthesia, dentists can provide more comfortable care to their pediatric patients.
Specific Aims/ Hypothesis
-Specific Aim 1: To compare articaine to lidocaine with achieving effective local anesthesia in the mandible and upper arch of pediatric dental patients.
Hypothesis: The solubility of articaine will provide more effective anesthetic delivery through the soft and hard tissue of the mandible following buccal infiltration, eliminating the need for multiple injections.
-Specific Aim 2: To identify which type of anesthetic provides the best patient experience by way of measuring patient comfort at various stages of the dental procedure.
Hypothesis: The patient will have an equally comfortable experience during the dental procedure when articaine or lidocaine is used.
- Conditions
- Anesthesia, Dental, Pain, Postoperative
- Being tested
- lidocaine, articaine
- Keywords
- lidocaine injection, articaine injections, pediatric dental anesthesia, post dental procedure pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
Also called local anesthetic
A buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed of 2% lidocaine with 1:100,000 epinephrine will be administered.
articaineDrug
Also called local anesthetic
A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered
| Study group | Role | What they receive |
|---|---|---|
| lidocaine then articaine | Experimental | For the first dental procedure 2% lidocaine with 1:100,000 epinephrine will be administered with a buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed. For the second dental procedure a single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered. Receives: Drug: lidocaine; Drug: articaine |
| articaine then lidocaine | Experimental | For the first dental procedure a single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered. For the second dental procedure 2% lidocaine with 1:100,000 epinephrine will be administered with a buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed. Receives: Drug: lidocaine; Drug: articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during anesthesia injection using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Measured: Anesthesia injection is usually about 10 min before the dental procedure starts.
Pain during rubber dam placement using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Measured: Rubberdam placement is usually about 5 min before the dental procedure starts.
Pain during tooth preparation using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Measured: Tooth preparation occurs during the dental procedure.
Pain during pulp opening using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Measured: Pulp opening occurs during the dental procedure.
Pain during restoration placement using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Measured: Restoration placement is at the end of the dental procedure, approximately 1 hour.
Secondary outcomes (2)
Additional injections of local anesthetic at the first visit
The number of extra injections to achieve anesthesia will be documented for each participant.
Measured: At the completion of the first visit, approximately 1 hour.
Additional injections of local anesthetic at the second visit
The number of extra injections to achieve anesthesia will be documented for each participant.
Measured: At the completion of the second visit, approximately 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study startSep 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: The research did not start and the PI transitioned to another institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, DentalStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayapriyaa Shanmugham, BDS MPH DrPH, Principal investigator, BU Henry M. Goldman School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318952
- Sponsor's protocol ID
- H-33755
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2017
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Articaine vs. Lidocaine When Used for Local Infiltration in Pediatric Dental Procedures
- ClinicalTrials.gov ID
- NCT03318952
- Acronym / sponsor ID
- H-33755
- Conditions
- Anesthesia, Dental, Pain, Postoperative
- Keywords
- lidocaine injection, articaine injections, pediatric dental anesthesia, post dental procedure pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research did not start and the PI transitioned to another institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Oct 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.
The purpose of this study is to compare the efficacy of two types of local anesthesia (articaine and lidocaine) for infiltration anesthesia during restorative dental procedures on lower teeth in pediatric patients. The patients will require similar dental operative procedures on both right and left sides of the mandible in order to qualify for this study. The study will require at least two dental appointments, where a randomized, cross-over study methodology will be utilized. All subjects will be treated by the same dentist. The comfort of the patient will be assessed at various points during the procedure using the Wong-Baker Faces Scale.
Detailed description
This study will compare articaine to lidocaine with overall quality of anesthesia. When administering lidocaine, the investigator will follow standard of care by administering a buccal infiltration injection followed by 2-3 interpapillary injections, one at each gingival papilla where the rubber dam clamp will be placed and possibly more if needed in areas where dental treatment will be provided. A single buccal infiltration injection of articaine will be administered, with the hypothesis that articaine is a stronger anesthestic and will deliver palatal anesthesia with a single injection, eliminating the interpapillary injections required for lidocaine to achieve adequate soft tissue anesthesia. The comfort of the patient during multiple steps of the dental treatment will be recorded. A randomized, cross-over methodology will be used. This study seeks to find whether adequate anesthesia in the mandible can be achieved with a single injection of articaine in the buccal aspect of the jaw instead of having to administer multiple injections of lidocaine, which can increase patient anxiety and discomfort. By decreasing the number of injections needed for children during dental treatment while providing adequate local anesthesia, dentists can provide more comfortable care to their pediatric patients.
Specific Aims/ Hypothesis
-Specific Aim 1: To compare articaine to lidocaine with achieving effective local anesthesia in the mandible and upper arch of pediatric dental patients.
Hypothesis: The solubility of articaine will provide more effective anesthetic delivery through the soft and hard tissue of the mandible following buccal infiltration, eliminating the need for multiple injections.
-Specific Aim 2: To identify which type of anesthetic provides the best patient experience by way of measuring patient comfort at various stages of the dental procedure.
Hypothesis: The patient will have an equally comfortable experience during the dental procedure when articaine or lidocaine is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine then articaine | Experimental | Drug: lidocaine, Drug: articaineFor the first dental procedure 2% lidocaine with 1:100,000 epinephrine will be administered with a buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed. For the second dental procedure a single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered. |
| articaine then lidocaine | Experimental | Drug: lidocaine, Drug: articaineFor the first dental procedure a single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered. For the second dental procedure 2% lidocaine with 1:100,000 epinephrine will be administered with a buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients receiving dental care at Boston Medical Center Pediatric Dental Clinic, Boston University Pediatric Oral Health Center, and East Boston Neighborhood Health Center Pediatric Dental Clinic
- Patients needing similar restorative dental procedures to primary molar teeth on both sides of the maxillary arch or upper arch
- Boys and girls between ages 4 to 14 years
- English speaking and be able to understand verbal assent.
Key exclusion criteria (2 listed)
- Patients for whom the use of articaine is contraindicated such as patients with Acetylcholine esterase deficiency
- Patients for whom the use of lidocaine is contraindicated in patients taking metronidazole
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 |
|---|---|---|
| lidocaineAlso: local anestheticA buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed of 2% lidocaine with 1:100,000 epinephrine will be administered. | Drug | articaine then lidocaine, lidocaine then articaine |
| articaineAlso: local anestheticA single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered | Drug | articaine then lidocaine, lidocaine then articaine |
Primary outcome
Pain during anesthesia injection using the Wong-Baker faces scale
Time frame: Anesthesia injection is usually about 10 min before the dental procedure starts.
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Pain during rubber dam placement using the Wong-Baker faces scale
Time frame: Rubberdam placement is usually about 5 min before the dental procedure starts.
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Pain during tooth preparation using the Wong-Baker faces scale
Time frame: Tooth preparation occurs during the dental procedure.
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Pain during pulp opening using the Wong-Baker faces scale
Time frame: Pulp opening occurs during the dental procedure.
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Pain during restoration placement using the Wong-Baker faces scale
Time frame: Restoration placement is at the end of the dental procedure, approximately 1 hour.
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
2 secondary outcomes
Additional injections of local anesthetic at the first visit
Time frame: At the completion of the first visit, approximately 1 hour.
Additional injections of local anesthetic at the second visit
Time frame: At the completion of the second visit, approximately 1 hour.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Related publication.Link provided by the sponsor.
- Related publication.Link provided by the sponsor.
- Related publication.Link provided by the sponsor.
- Related publication.Link provided by the sponsor.
- Related publication.Link provided by the sponsor.
- 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.
Jayapriyaa Shanmugham, BDS MPH DrPH principal investigator
BU Henry M. Goldman School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine and articaine in people with Anesthesia, Dental and Pain, Postoperative, run by Boston University 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 3 Nov 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 during anesthesia injection using the Wong-Baker faces scale (time frame: Anesthesia injection is usually about 10 min before the dental procedure starts.). The study lists 5 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 3 Nov 2022.