Anesthesia of Mucous MembranePhase 4NCT01951820
Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis
A Phase 4 study testing Pliaglis, Benzocaine and Articaine in people with Anesthesia of Mucous Membrane, run by University of Michigan at 1 site in United States.
Trial summary
The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia of Mucous Membrane
- What is being tested?
- Pliaglis, Benzocaine and Articaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal healthy adults 18+ yrs old requiring root canal treatment of maxillary molars
- Patients with healthy mucosal tissues, and who do not have pain on palpation at injection site
- Ability to use and understand a VAS score
- Ability to use and understand a VAS score
- No know allergies to topical anesthetics being used
Who cannot join
- Allergy or other contraindications to topical anesthetics
- Allergy to epinephrine or local anesthetics
- Broken/unhealthy mucosal tissues and pain on palpation at injection site
- Patients needing endodontic therapy on maxillary anterior teeth
- Inability to consent to participate in the study
- Patients who have used analgesics within 6 hours of appointment time
- Pregnant and nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Dental School
Ann Arbor, Michigan, 48109
About this study
Official title: Comparison of Efficacy of Two Topical Anesthetics: Benzocaine Versus Pliaglis for Control of Pain Associated With Dental Needle Insertion in the Palate, A Double Blind Study
The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.
Read the detailed description
This project will be a double blind study comparing the efficacy of two different topical anesthetics used to reduce the pain associated with insertion of dental needles on the palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.
In order to complete a number of different dental procedures, it is often necessary to provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are often uncomfortable and even painful. In an effort to increase patient comfort, a topical anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of the hard palate as part of the initial step in standard local anesthetic injection. At the injection site and prior to the needle stick, the mucosa will be topically anesthetized by using one of the two different test compounds (Benzocaine or Pliaglis). After the injection, patients will be asked to score the level of discomfort associated with the needle stick.
The purpose of the project is to determine if there is a clinical difference in the level of pain felt upon needle stick, between the two different topical anesthetics.
- Conditions
- Anesthesia of Mucous Membrane
- Being tested
- Pliaglis, Benzocaine, Articaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PliaglisDrug
Also called lidocaine and tetracaine
Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.
BenzocaineDrug
Also called Hurricaine
Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.
ArticaineDrug
Also called Septocaine
Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed
| Study group | Role | What they receive |
|---|---|---|
| Benzocaine | Active comparator | Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Receives: Drug: Benzocaine; Drug: Articaine |
| Pliaglis | Experimental | Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. Receives: Drug: Pliaglis; Drug: Articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale
The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).
Measured: 2.5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anesthesia of Mucous MembraneStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Endodontists
- Responsible party
- Principal investigator, Brian Royle, University of Michigan
- Investigators
- Brian l Royle, DDS, Principal investigator, University of Michigan department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951820
- Sponsor's protocol ID
- HUM00075036
- Status last verified
- Jun 2016
- First submitted
- 22 Aug 2013
- Last updated
- 22 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Two Topical Anesthetics: Benzocaine Versus Pliaglis for Control of Pain Associated With Dental Needle Insertion in the Palate, A Double Blind Study
- ClinicalTrials.gov ID
- NCT01951820
- Acronym / sponsor ID
- HUM00075036
- Conditions
- Anesthesia of Mucous Membrane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Association of Endodontists
- Study start
- Aug 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Posted 22 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.
Detailed description
This project will be a double blind study comparing the efficacy of two different topical anesthetics used to reduce the pain associated with insertion of dental needles on the palatal mucosa. The two topical anesthetics being compared are 20% Benzocaine, and Pliaglis.
In order to complete a number of different dental procedures, it is often necessary to provide local anesthesia of the palate. Intraoral injections into the palatal mucosa are often uncomfortable and even painful. In an effort to increase patient comfort, a topical anesthetic is often used prior to the injection. Test subjects undergoing routine endodontic treatment on maxillary teeth will have a 27- gauge dental needle inserted into the mucosa of the hard palate as part of the initial step in standard local anesthetic injection. At the injection site and prior to the needle stick, the mucosa will be topically anesthetized by using one of the two different test compounds (Benzocaine or Pliaglis). After the injection, patients will be asked to score the level of discomfort associated with the needle stick.
The purpose of the project is to determine if there is a clinical difference in the level of pain felt upon needle stick, between the two different topical anesthetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzocaine | Active comparator | Drug: Benzocaine, Drug: ArticaineBenzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. |
| Pliaglis | Experimental | Drug: Pliaglis, Drug: ArticainePliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- normal healthy adults 18+ yrs old requiring root canal treatment of maxillary molars
- Patients with healthy mucosal tissues, and who do not have pain on palpation at injection site
- Ability to use and understand a VAS score
- Ability to use and understand a VAS score
- No know allergies to topical anesthetics being used
Key exclusion criteria (7 listed)
- Allergy or other contraindications to topical anesthetics
- Allergy to epinephrine or local anesthetics
- Broken/unhealthy mucosal tissues and pain on palpation at injection site
- Patients needing endodontic therapy on maxillary anterior teeth
- Inability to consent to participate in the study
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 |
|---|---|---|
| PliaglisAlso: lidocaine and tetracaineApply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic. | Drug | Pliaglis |
| BenzocaineAlso: HurricaineApply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic. | Drug | Benzocaine |
| ArticaineAlso: SeptocaineInjection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed | Drug | Benzocaine, Pliaglis |
Primary outcome
Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale
Time frame: 2.5 minutes
The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Anesthesia of Mucous Membrane
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
RecruitingPhase 3
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
ENT Disorder, Nasal Procedures
Not yet recruiting
ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation
Bacterial Transmission, Intubation Intratracheal
Recruiting
Comparison of Conventional Buccal Nerve Block Versus Buccal Nerve Trunk Block During Extraction of Posterior Mandibular Teeth
Pain (Visceral, Somatic, or Neuropathic)
Not yet recruiting
Insertion of a Transoesophageal Echocardiography Probe Using McGRATH
Echocardiography, Transesophageal, Cardiac Surgery
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.
Brian l Royle, DDS principal investigator
University of Michigan department of Endodontics
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 Pliaglis, Benzocaine and Articaine in people with Anesthesia of Mucous Membrane, run by University of Michigan 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 5 inclusion and 7 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 Jul 2016. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale (time frame: 2.5 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 Jul 2016.