Dental Anesthesia EfficacyPhase 1NCT01073371
Anesthetic Efficacy of Liposomal Prilocaine in Maxillary Infiltration Anesthesia
A Phase 1 study testing Prilocaine in people with Dental Anesthesia Efficacy, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anesthesia Efficacy
- What is being tested?
- Prilocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Nov 2009
- Phase
- Phase 1
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good health
- no history of allergy to the components of the local anesthetic formulations tested
- maxillary canine, lateral incisor, and first premolar responsible to electric stimulation
Who cannot join
- intake of any medication that would alter pain perception
- history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar
- systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Anesthetics New Formulations: From Development to Clinical Tests
This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
- Conditions
- Dental Anesthesia Efficacy
- Being tested
- Prilocaine
- Keywords
- Liposome, Prilocaine, Dental anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrilocaineDrug
Also called Citocaína®
1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine
| Study group | Role | What they receive |
|---|---|---|
| liposome-encapsulated 3% prilocaine | Active comparator | Not described Receives: Drug: Prilocaine |
| 3% plain prilocaine | Active comparator | Not described Receives: Drug: Prilocaine |
| 3% prilocaine with 0,03IU/mL felypressin | Active comparator | Not described Receives: Drug: Prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia success, onset and duration of pulpal and gingival anesthesia.
Measured: 10 minutes
Secondary outcomes (1)
Injection pain - Visual Analogue Scale
Measured: 1 minute after the injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startJul 2008
- Primary completionAug 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Anesthesia EfficacyStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Eneida de Paula, PhD, Study director, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073371
- Sponsor's protocol ID
- 131843/2008-7
- Status last verified
- Jun 2008
- First submitted
- 19 Feb 2010
- Last updated
- 23 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthetics New Formulations: From Development to Clinical Tests
- ClinicalTrials.gov ID
- NCT01073371
- Acronym / sponsor ID
- 131843/2008-7
- Conditions
- Dental Anesthesia Efficacy
- Keywords
- Liposome, Prilocaine, Dental anesthesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jul 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 23 Feb 2010 (estimated)
- 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.
This blinded randomized, crossover, three period study aim to evaluate the anesthetic efficacy of liposome-encapsulated 3% prilocaine compared to 3% plain prilocaine and 3% prilocaine with 0,03IU/mL felypressin, after 1.8mL infiltration in the buccal sulcus of the maxillary right canine, in 32 volunteers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| liposome-encapsulated 3% prilocaine | Active comparator | Drug: Prilocaine |
| 3% plain prilocaine | Active comparator | Drug: Prilocaine |
| 3% prilocaine with 0,03IU/mL felypressin | Active comparator | Drug: Prilocaine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good health
- no history of allergy to the components of the local anesthetic formulations tested
- maxillary canine, lateral incisor, and first premolar responsible to electric stimulation
Key exclusion criteria (3 listed)
- intake of any medication that would alter pain perception
- history of trauma or sensitivity, caries, restorations, periodontal disease and endodontic treatment in the maxillary canine, lateral incisor, and first premolar
- systemic disease
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 |
|---|---|---|
| PrilocaineAlso: Citocaína®1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine | Drug | 3% plain prilocaine, 3% prilocaine with 0,03IU/mL felypressin, liposome-encapsulated 3% prilocaine |
Primary outcome
Anesthesia success, onset and duration of pulpal and gingival anesthesia.
Time frame: 10 minutes
1 secondary outcome
Injection pain - Visual Analogue Scale
Time frame: 1 minute after the injections
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 23 Feb 2010.
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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.
Eneida de Paula, PhD study director
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prilocaine in people with Dental Anesthesia Efficacy, run by University of Campinas, Brazil 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 3 inclusion and 3 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 23 Feb 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Anesthesia success, onset and duration of pulpal and gingival anesthesia. (time frame: 10 minutes). 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 23 Feb 2010.