Underdosing of Local Anesthetics, Initial EncounterPhase 1NCT01307969
Formulations of Liposomal Local Anesthetics
A Phase 1 study testing Ropivacaine in people with Underdosing of Local Anesthetics, Initial Encounter, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Underdosing of Local Anesthetics, Initial Encounter
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2007to Jun 2007
- 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Formulations of Liposomal Local Anesthetics for Dental Anesthesia
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.
Read the detailed description
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.
- Being tested
- Ropivacaine
- Keywords
- liposomes, ropivacaine, dental anesthesia, dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called 0,5% ropivacaine encapsulated in liposomes, 0,5% ropivacaine with epinephrine 1:200.000, 2% lidocaine with epinephrine 1:100.000
1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.
| Study group | Role | What they receive |
|---|---|---|
| Anesthetic efficacy | Experimental | Local anesthetics were injected at the apex of the maxillary right canine. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
After anesthetic injection the pulpal response was assessed by an electrical pulp tester.
Measured: 100 minutes
Secondary outcomes (1)
Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
- Study completionJun 2007
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 Underdosing of Local Anesthetics, Initial EncounterStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 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
- Investigators
- Michelle Franz-Montan, PhD, Principal investigator, Researcher at Unicamp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307969
- Sponsor's protocol ID
- 164/2006
- Status last verified
- Feb 2011
- First submitted
- 16 Feb 2011
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franz-Montan M, de Paula E, Groppo FC, Ranali J, Volpato MC. Efficacy of liposome-encapsulated 0.5% ropivacaine in maxillary dental anaesthesia. Br J Oral Maxillofac Surg. 2012 Jul;50(5):454-8. doi: 10.1016/j.bjoms.2011.07.010. Epub 2011 Aug 9.
PubMed 21831487
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formulations of Liposomal Local Anesthetics for Dental Anesthesia
- ClinicalTrials.gov ID
- NCT01307969
- Acronym / sponsor ID
- 164/2006
- Keywords
- liposomes, ropivacaine, dental anesthesia, dentistry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 3 Mar 2011 (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 cross-over study aim to evaluate the efficacy of liposome-encapsulated ropivacaine formulation for dental anesthesia.
Detailed description
This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5% ropivacaine for dental anesthesia after maxillary infiltration.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthetic efficacy | Experimental | Drug: RopivacaineLocal anesthetics were injected at the apex of the maxillary right canine. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
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 |
|---|---|---|
| RopivacaineAlso: 0,5% ropivacaine encapsulated in liposomes, 0,5% ropivacaine with epinephrine 1:200.000, 2% lidocaine with epinephrine 1:100.0001,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine. | Drug | Anesthetic efficacy |
Primary outcome
After anesthetic injection the pulpal response was assessed by an electrical pulp tester.
Time frame: 100 minutes
1 secondary outcome
Duration of soft tissue anesthesia was measured as the time from beginning to end of lip and gingival numbness.
Time frame: 240 minutes
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 3 Mar 2011.
- Derived from this study: PubMed 21831487Franz-Montan M, de Paula E, Groppo FC, Ranali J, Volpato MC. Efficacy of liposome-encapsulated 0.5% ropivacaine in maxillary dental anaesthesia. Br J Oral Maxillofac Surg. 2012 Jul;50(5):454-8. doi: 10.1016/j.bjoms.2011.07.010. Epub 2011 Aug 9.
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.
Michelle Franz-Montan, PhD principal investigator
Researcher at Unicamp
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 Ropivacaine in people with Underdosing of Local Anesthetics, Initial Encounter, 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 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 Mar 2011. 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?
After anesthetic injection the pulpal response was assessed by an electrical pulp tester. (time frame: 100 minutes). 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 NCT01307969, 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 3 Mar 2011.