Dental TraumaPhase 1NCT05912335
Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries
A Phase 1 study testing Topical anesthetic in people with Dental Trauma and Local Anesthesia, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs (local anesthetic) - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA (topical anesthetic available on the market) and placebo… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Trauma, Local Anesthesia, Oral Cavity Disease
- What is being tested?
- Topical anesthetic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jun 2021to 3 May 2022
- 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
- Healthy participants
- No lesions in the study area
- Have already been submitted to local anesthesia without intercurrence
Who cannot join
- Used any drugs that change the pain sensibility 1 week before
- Smokers
- Alcoholic
Trial locations and contacts
1 site in 1 country.
About this study
In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs (local anesthetic) - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA (topical anesthetic available on the market) and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).
Read the detailed description
Dental treatment presents numerous innovations, but the pain associated with the administration of local anesthesia (LA) continuous to be a traumatic procedure for many patients. Although we use topical anesthetics (TA) to reduce pain, the commercially available formulations are only effective in preventing the pain of the needle puncture.
This project aims to evaluate the clinical efficacy of xanthan-based hydrogels (2%) containing LAs encapsulated in nanostructured lipid carriers (CLN), reducing pain during puncture and injection of LA in the palatine mucosa. In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. The computerized Morpheus® anesthetic injector will be used in order to control the variables of volume and injection speed. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS). Hydrogels containing CLN are expected to have good mechanical properties and allow the permeation of LAs efficiently through the oral mucosal epithelium. In addition, they can improve the efficacy of topical anesthesia in order to perform a painless LA in the palatal mucosa.
- Conditions
- Dental Trauma, Local Anesthesia, Oral Cavity Disease
- Being tested
- Topical anesthetic
- Keywords
- Topical Anesthesia, Topical Formulation, Oral Mucosa, Lidocaine, Prilocaine, Nanostructured Lipid Carrier
- Medical subject headings
- Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical anestheticDrug
Also called Topical Formulation
The topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%) | Active comparator | Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed.
100 mg. Receives: Drug: Topical anesthetic |
| Xanthan hydrogel 2% | Placebo comparator | Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed.
100 mg. Receives: Drug: Topical anesthetic |
| Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC | Experimental | Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed.
100 mg. Local Anesthetic encapsulated in nanostructured lipid carriers (NLC) Receives: Drug: Topical anesthetic |
| Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) | Experimental | Applied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed.
100 mg. Receives: Drug: Topical anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic.
The blind investigator evaluated the values obtained on VAS, with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a a higher score means a worse outcome.
Measured: 2 minutes
Secondary outcomes (1)
Pain sensitivity assessment by Visual Analogue Scale after the injection of the local anesthetic.
The blind investigator evaluated the values obtained on VAS, with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a a higher score means a worse outcome.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start2 Jun 2021
- Primary completion20 Feb 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental TraumaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine, and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Franz Montan Braga Leite, DDS, MSc, PhD, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912335
- Sponsor's protocol ID
- CAAE: 45317521.9.0000.5418
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficiency of Xanthan Hydrogels Containing Local Anesthetics Encapsulated in Nanostructured Lipid Carries
- ClinicalTrials.gov ID
- NCT05912335
- Acronym / sponsor ID
- CAAE: 45317521.9.0000.5418
- Conditions
- Dental Trauma, Local Anesthesia, Oral Cavity Disease
- Keywords
- Topical Anesthesia, Topical Formulation, Oral Mucosa, Lidocaine, Prilocaine, Nanostructured Lipid Carrier
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 22 Jun 2023 (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.
In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs (local anesthetic) - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA (topical anesthetic available on the market) and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).
Detailed description
Dental treatment presents numerous innovations, but the pain associated with the administration of local anesthesia (LA) continuous to be a traumatic procedure for many patients. Although we use topical anesthetics (TA) to reduce pain, the commercially available formulations are only effective in preventing the pain of the needle puncture.
This project aims to evaluate the clinical efficacy of xanthan-based hydrogels (2%) containing LAs encapsulated in nanostructured lipid carriers (CLN), reducing pain during puncture and injection of LA in the palatine mucosa. In a crossover, randomized, placebo-controlled, double-blind study, 40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. The computerized Morpheus® anesthetic injector will be used in order to control the variables of volume and injection speed. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS). Hydrogels containing CLN are expected to have good mechanical properties and allow the permeation of LAs efficiently through the oral mucosal epithelium. In addition, they can improve the efficacy of topical anesthesia in order to perform a painless LA in the palatal mucosa.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- 40 volunteers will receive the following formulations: hydrogels containing LAs - lidocaine, and prilocaine (both at 2.5%) encapsulated in CLN (XAN-CLN) or not (XAN-CLN ), EMLA and placebo hydrogel. The formulations will be applied for 2 minutes, bilaterally on the palatal mucosa (first premolar region), in two distinct sessions. Soon after the removal of the topical formulation, an AL will be performed at the region using 0.3 mL of anesthetic solution at an injection speed of 1 mL/min. Pain resulting from needle insertion and LA injection will be measured using two visual analog scales (VAS).
| Arm | Type | Receives |
|---|---|---|
| Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%) | Active comparator | Drug: Topical anestheticApplied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg. |
| Xanthan hydrogel 2% | Placebo comparator | Drug: Topical anestheticApplied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg. |
| Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC | Experimental | Drug: Topical anestheticApplied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg. Local Anesthetic encapsulated in nanostructured lipid carriers (NLC) |
| Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) | Experimental | Drug: Topical anestheticApplied at palatal mucosa (first premolar region), for 2 minutes. After that, this formulation will be removed. 100 mg. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants
- No lesions in the study area
- Have already been submitted to local anesthesia without intercurrence
Key exclusion criteria (3 listed)
- Used any drugs that change the pain sensibility 1 week before
- Smokers
- Alcoholic
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 |
|---|---|---|
| Topical anestheticAlso: Topical FormulationThe topical anesthetic, or topical formulation, was applied to the palatal mucosa for 2 minutes. | Drug | Topical anesthetic available on the market - Lidocaine (2.5%), Prilocaine (2.5%), Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%), Xanthan hydrogel (2%), Lidocaine (2.5%), Prilocaine (2.5%) in NLC, Xanthan hydrogel 2% |
Primary outcome
Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic.
Time frame: 2 minutes
The blind investigator evaluated the values obtained on VAS, with a rule, the left far end mean 0, for no pain at all and the right far end mean 100 for maximum pain. Therefore, a a higher score means a worse outcome.
1 secondary outcome
Pain sensitivity assessment by Visual Analogue Scale after the injection of the local anesthetic.
Time frame: 2 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 22 Jun 2023.
- 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 Phase 1 study testing Topical anesthetic in people with Dental Trauma and Local Anesthesia, 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 22 Jun 2023. 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?
Pain sensitivity assessment by Visual Analogue Scale after the puncture of the needle of the local anesthetic. (time frame: 2 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 22 Jun 2023.