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Dental AnesthesiaPhase 4NCT01474382

Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients

A Phase 4 study testing OraVerse in people with Dental Anesthesia and Anesthesia, Local, run by Novocol Pharmaceutical of Canada, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg. Read more about this study

Who is it for?
Ages 2 to 5 yearsHealthy volunteers can take part
What is being tested?
OraVerse
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
7 sitesUnited States
Study dates
Feb 2012to Aug 2014
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 2 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female, 2 to 5 years of age
  • Sufficiently healthy as determined by the Investigator to receive routine dental care
  • Requires a restorative procedure (restoration/filling) in a single quadrant of the mouth
  • Requires local anesthesia with lidocaine 2% with 1:100,000 epinephrine administered by submucosal injection
  • For subjects undergoing mandibular procedures, require an inferior alveolar nerve block for the restorative procedure
  • Dental procedure(s) completed within 60 minutes of injection of local anesthetic
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  • For subjects 4 and 5 years of age, can be trained in standardized lip/tongue palpation procedure and pFAB
  • Subjects who are trainable in pFAB and standardized lip/tongue palpation procedure have either:
  • normal pFAB at baseline prior to administration of local anesthetic and
  • at least one abnormal function (smiling, speaking, drinking or drooling) at the completion of the dental procedure OR
  • normal lip sensation at baseline prior to administration of local anesthetic and
  • numbness of the relevant lip quadrant at completion of the dental procedure
  • Subjects give written or verbal assent, as capable and appropriate, and parent(s) or legal guardian(s) give written informed consent

Who cannot join

  • Weight less than 10 kg
  • Weight less than 15 kg if 4 or 5 years of age
  • History or presence of any condition that contraindicates routine dental care or use of local anesthetic
  • Requires more than ¼ cartridge of local anesthetic if weight is ≥ 10 kg and < 15 kg, more than ½ cartridge of local anesthetic if weight is ≥ 15 kg and < 30 kg, and more than 1 cartridge of local anesthetic if weight is ≥ 30 kg, excluding supplemental injections
  • Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, nitrous oxide or topical benzocaine
  • Has used any investigational drug and/or participated in any clinical study within 30 days of study drug administration
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  • Has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (STA)
  • Any use of commercial OraVerse™ within 30 days of study drug administration
  • Use of opioid or opioid-like analgesics within 24 hours prior to administration of local anesthetic
  • Requires the use of local anesthetic other than lidocaine 2% with 1:100,000 epinephrine to perform the scheduled dental procedure
  • Requires the use of general anesthesia or sedatives except for nitrous oxide to perform the scheduled dental procedure
  • Any condition which in the opinion of the Investigator increases the risk to the subject of participating in this study or decreases the likelihood of compliance with the protocol

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Indiana University School of Dentistry

    Indianapolis, Indiana, 46202

  • University of Pennsylvania School of Dental

    Philadelphia, Pennsylvania, 19104-6030

  • University of Pittsburgh School of Dental Medicine

    Pittsburgh, Pennsylvania, 15261

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • University of California, San Francisco

    San Francisco, California, 94143

  • Center for Pediatric Dentistry

    Seattle, Washington, 98115

Other trials in United States

About this study

Official title: A Phase 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures

The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.

Read the detailed description

This Phase 4 clinical study is designed as a multicenter, randomized, double-blinded, controlled study to evaluate the safety and efficacy of OraVerse in approximately 150 children 2 to 5 years of age. OraVerse or sham injection is administered at the completion of a dental procedure requiring local anesthesia with lidocaine 2% with 1:100,000 epinephrine. The dental procedure(s) comprising restoration/fillings shall be performed in a single quadrant of the mouth.

The primary endpoint is safety and tolerability of OraVerse as measured by adverse events, vital signs, oral cavity assessments, nerve injury, and analgesics for intraoral pain. Secondary objectives in subjects 4 and 5 years of age include the safety and tolerability of OraVerse as measured by pain assessments using W-B PRS and evaluation of efficacy assessed by a pediatric Functional Assessment Battery (pFAB) and standardized lip and tongue palpation procedure.

Being tested
OraVerse, Sham injection
Keywords
OraVerse, Safety, Efficacy, Pediatric, Reversal of dental anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OraVerseDrug

    1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight

  • Sham injectionOther

    No drug administered, simulation of injection used in same manner as drug

Study groups in NCT01474382
Study groupRoleWhat they receive
OraVerseExperimentalOraVerse in doses of either 1/4, 1/2 or 1 cartridge (1.8mL)
Receives: Drug: OraVerse
Sham injectionSham comparatorDentist simulates injection with dental syringe
Receives: Other: Sham injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events

    Measured: Up to 3 days

  2. Clinically significant changes in vital signs

    Blood pressure and pulse

    Measured: Up to 3 days

  3. Clinically significant changes in oral cavity assessments

    Measured: Up to 3 days

  4. Nerve injury

    Measured: Up to 3 days

  5. Analgesics required for intraoral pain

    Measured: Up to 3 days

Secondary outcomes (4)

  1. incidence, severity and duration of intraoral pain as measured by W-B PRS

    Wong-Baker Pain Rating Scale used to assess subject pain

    Measured: Up to 3 days

  2. Time to normal function

    Measured by pediatric Functional Assessment Battery (pFAB) to determine when speaking, eating, drinking, drooling return to baseline

    Measured: Up to 3 days

  3. Time to normal lip sensation

    Measures time to normal lip and tongue sensation using standardized lip/tongue palpation procedure

    Measured: Up to 3 days

  4. Time to normal tongue sensation

    Measures time to normal tongue sensation using standardized lip/tongue palpation procedure

    Measured: Up to 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

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
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01474382
Sponsor's protocol ID
PHE-11-001
Status last verified
Aug 2014
First submitted
11 Nov 2011
Last updated
29 Aug 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Hersh EV, Moore PA, Papas AS, Goodson JM, Navalta LA, Rogy S, Rutherford B, Yagiela JA; Soft Tissue Anesthesia Recovery Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in adolescents and adults. J Am Dent Assoc. 2008 Aug;139(8):1080-93. doi: 10.14219/jada.archive.2008.0311.

    PubMed 18682623

  • Moore PA, Hersh EV, Papas AS, Goodson JM, Yagiela JA, Rutherford B, Rogy S, Navalta L. Pharmacokinetics of lidocaine with epinephrine following local anesthesia reversal with phentolamine mesylate. Anesth Prog. 2008 Summer;55(2):40-8. doi: 10.2344/0003-3006(2008)55[40:POLWEF]2.0.CO;2.

    PubMed 18547152

  • Tavares M, Goodson JM, Studen-Pavlovich D, Yagiela JA, Navalta LA, Rogy S, Rutherford B, Gordon S, Papas AS; Soft Tissue Anesthesia Reversal Group. Reversal of soft-tissue local anesthesia with phentolamine mesylate in pediatric patients. J Am Dent Assoc. 2008 Aug;139(8):1095-104. doi: 10.14219/jada.archive.2008.0312.

    PubMed 18682624

  • Laviola M, McGavin SK, Freer GA, Plancich G, Woodbury SC, Marinkovich S, Morrison R, Reader A, Rutherford RB, Yagiela JA. Randomized study of phentolamine mesylate for reversal of local anesthesia. J Dent Res. 2008 Jul;87(7):635-9. doi: 10.1177/154405910808700717.

    PubMed 18573982

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing OraVerse in people with Dental Anesthesia and Anesthesia, Local, run by Novocol Pharmaceutical of Canada, Inc. at 7 sites 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 13 inclusion and 12 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 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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. 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 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?

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?

Incidence and severity of adverse events (time frame: Up to 3 days). The study lists 5 primary outcomes in all. 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 NCT01474382, which also lists 4 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 29 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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