Administration, Topical DrugPhase 1NCT01054547
Topical Formulations of Liposomal Local Anesthetics
A Phase 1 study testing Ropivacaine in people with Administration, Topical Drug and Administration, Topical, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations. Read more about this study
- Who is it for?
- Ages 18 to 43 yearsHealthy volunteers can take part
- Conditions the study is for
- Administration, Topical Drug, Administration, Topical, Anesthetic Drugs
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Apr 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 43 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: Local Anesthetic Activity of Liposomal Formulations in Dentistry
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.
Read the detailed description
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.
- Being tested
- Ropivacaine
- Keywords
- topical anesthetic, liposomal ropivacaine, dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Topical anesthesia in the palatal mucosa
100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
RopivacaineDrug
Also called Topical anesthesia in the buccal mucosa.
100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal ropivacaine, topical | Placebo comparator | The topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa. Receives: Drug: Ropivacaine |
| Liposomal ropivacaine, palatal mucosa | Placebo comparator | Topical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester.
Measured: 10 minutes
Secondary outcomes (1)
The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact).
Measured: 10 seconds after removal of topical formulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startSep 2006
- Primary completionDec 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Administration, Topical DrugStudies 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, Care provider, Investigator
- Enrolment
- 80 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054547
- Sponsor's protocol ID
- 093/2006
- Status last verified
- May 2006
- First submitted
- 20 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposome-encapsulated ropivacaine for intraoral topical anesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Dec;110(6):800-4. doi: 10.1016/j.tripleo.2010.07.005.
PubMed 21112538Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23.
PubMed 21106282
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthetic Activity of Liposomal Formulations in Dentistry
- ClinicalTrials.gov ID
- NCT01054547
- Acronym / sponsor ID
- 093/2006
- Keywords
- topical anesthetic, liposomal ropivacaine, dentistry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 22 Jan 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 cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.
Detailed description
This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal ropivacaine, topical | Placebo comparator | Drug: RopivacaineThe topical anesthetics were applied at the region of right and left maxillary lateral incisors at the buccal mucosa. |
| Liposomal ropivacaine, palatal mucosa | Placebo comparator | Drug: RopivacaineTopical formulations were applied at the palatal mucosa at the right canine region and efficacy of topical formulations was accessed through insertion of a 30 gauge needle and injection of anesthetic solution. |
Who may qualify
- Ages
- 18 to 43 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: Topical anesthesia in the palatal mucosa100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes. | Drug | Liposomal ropivacaine, palatal mucosa |
| RopivacaineAlso: Topical anesthesia in the buccal mucosa.100 mg of the following formulations: Liposome-encapsulated 1 and 2% ropivacaine gel, liposome placebo gel and 20% benzocaine gel were applied once during 30 minutes. | Drug | Liposomal ropivacaine, topical |
Primary outcome
After topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester.
Time frame: 10 minutes
1 secondary outcome
The efficacy of the topical anesthetics was measured after a simulation of a local anesthesia in the application site (insertion of a 30 gauge needle until periosteum contact).
Time frame: 10 seconds after removal of topical formulation
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 22 Jan 2010.
- Derived from this study: PubMed 21112538Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposome-encapsulated ropivacaine for intraoral topical anesthesia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Dec;110(6):800-4. doi: 10.1016/j.tripleo.2010.07.005.
- Derived from this study: PubMed 21106282Franz-Montan M, de Paula E, Groppo FC, Silva AL, Ranali J, Volpato MC. Liposomal delivery system for topical anaesthesia of the palatal mucosa. Br J Oral Maxillofac Surg. 2012 Jan;50(1):60-4. doi: 10.1016/j.bjoms.2010.10.018. Epub 2010 Nov 23.
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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 Phase 1 study testing Ropivacaine in people with Administration, Topical Drug and Administration, Topical, 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 22 Jan 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. Some participants in this study may receive a placebo. 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 topical application of the local anesthetic formulations at the oral mucosa, their influence on pulpal response was assessed by an electrical pulp tester. (time frame: 10 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 NCT01054547, which also lists 2 linked publications.
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 22 Jan 2010.