Dental PainPhase 4NCT00846690
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel
A Phase 4 study testing benzocaine and TAC alternate gel in people with Dental Pain and Postoperative Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Pain, Postoperative Pain
- What is being tested?
- benzocaine and TAC alternate gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to May 2009
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Volunteers 18 years or older
- Ability to consent to participate in the research
- Ability to communicate a VAS score
- Generally healthy, ASA I and ASA II
- No known drug allergies
- Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence
Who cannot join
- Allergy or other contraindications to the topical anesthetics
- Inability to consent to participation in the study
- Use of analgesics prior to the procedure
- Vulnerable populations
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UT Pediatric Dentistry Clinic Houston Medical Center
6655 Travis Suite 460, Texas, 77030
Femme L Ambrosio, DDS, 858-603-6345, femme.l.ambrosio@uth.tmc.edu
Arthur H Jeske, DDS PhD, 7135004506, arthur.h.jeske@uth.tmc.edu
About this study
Official title: Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate
The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).
- Conditions
- Dental Pain, Postoperative Pain
- Being tested
- benzocaine, TAC alternate gel
- Keywords
- topical anesthetics, topical anesthesia, 20% benzocaine, TAC alternate gel, combination topical anesthetics, dental anesthesia
- Medical subject headings
- Toothache, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benzocaineDrug
Also called Hurricaine
20% benzocaine., topical placement onto site, minimal amount, for 1 minute
TAC alternate gelDrug
Also called 20% TAC alternate gel
use 1 pump, place topically onto site, leave for 1-3 minutes
| Study group | Role | What they receive |
|---|---|---|
| Benzocaine | Active comparator | serves as "active" control Receives: Drug: benzocaine |
| TAC | Experimental | serves as comparator Receives: Drug: TAC alternate gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale score
Measured: pre-op, insertion, every minute post-op for 10 minutes
Secondary outcomes (3)
blood pressure
Measured: three times pre-op, insertion, ten times post-op
oxygen saturation
Measured: three times pre-op, insertion, ten times post-op
heart rate
Measured: three times pre-op, insertion, ten times post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Femme L Ambrosio, DDS, Principal investigator, UT Health Science Center HoustonArthur H Jeske, DDS, PhD, Study chair, UT Health Science Center Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846690
- Sponsor's protocol ID
- HSC-DB-08-0484
- Status last verified
- Feb 2009
- First submitted
- 18 Feb 2009
- Last updated
- 19 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel for Control of Pain of Dental Needle Insertion in the Palate
- ClinicalTrials.gov ID
- NCT00846690
- Acronym / sponsor ID
- HSC-DB-08-0484
- Conditions
- Dental Pain, Postoperative Pain
- Keywords
- topical anesthetics, topical anesthesia, 20% benzocaine, TAC alternate gel, combination topical anesthetics, dental anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 19 Feb 2009 (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.
The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benzocaine | Active comparator | Drug: benzocaineserves as "active" control |
| TAC | Experimental | Drug: TAC alternate gelserves as comparator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteers 18 years or older
- Ability to consent to participate in the research
- Ability to communicate a VAS score
- Generally healthy, ASA I and ASA II
- No known drug allergies
Key exclusion criteria (4 listed)
- Allergy or other contraindications to the topical anesthetics
- Inability to consent to participation in the study
- Use of analgesics prior to the procedure
- Vulnerable populations
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 |
|---|---|---|
| benzocaineAlso: Hurricaine20% benzocaine., topical placement onto site, minimal amount, for 1 minute | Drug | Benzocaine |
| TAC alternate gelAlso: 20% TAC alternate geluse 1 pump, place topically onto site, leave for 1-3 minutes | Drug | TAC |
Primary outcome
visual analogue scale score
Time frame: pre-op, insertion, every minute post-op for 10 minutes
3 secondary outcomes
blood pressure
Time frame: three times pre-op, insertion, ten times post-op
oxygen saturation
Time frame: three times pre-op, insertion, ten times post-op
heart rate
Time frame: three times pre-op, insertion, ten times post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2009.
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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.
Femme L Ambrosio, DDS principal investigator
UT Health Science Center Houston
Arthur H Jeske, DDS, PhD study chair
UT Health Science Center Houston
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 benzocaine and TAC alternate gel in people with Dental Pain and Postoperative Pain, run by The University of Texas Health Science Center, Houston 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Feb 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Femme L Ambrosio, DDS (858 603-6345, femme.l.ambrosio@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale score (time frame: pre-op, insertion, every minute post-op for 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 19 Feb 2009.