Irreversible Pulpitis (Toothache)NCT01868776
Effect of Buffered Numbing Solution on Patients With Toothaches
A study testing buffered lidocaine and nonbuffered lidocaine in people with Irreversible Pulpitis (Toothache), run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irreversible Pulpitis (Toothache)
- What is being tested?
- buffered lidocaine and nonbuffered lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2013
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a diagnosis of irreversible pulpitis (toothache) in a mandibular posterior tooth (back/bottom tooth) with moderate to severe pain
- ages 18 -65 years of age
- in good health (ASA I or II)
- able to grant informed consent.
Who cannot join
- allergy to lidocaine (numbing solution
- significant medical problem (ASA III or IV)
- have taken CNS depressants or analgesic medications within the last 24 hours
- pregnancy or lactating
- non-English speaking
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Dentistry, Postle Hall
Columbus, Ohio, 43210
About this study
Official title: Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Patients presenting with toothaches will be given either a buffered numbing solution or a nonbuffered numbing solution. Neither the patient nor the operator will know which solution they will receive. Root canal treatment will be performed on the tooth and the ability of the buffered versus non-buffered numbing solutions will be compared.
- Conditions
- Irreversible Pulpitis (Toothache)
- Being tested
- buffered lidocaine, nonbuffered lidocaine
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buffered lidocaineDrug
nonbuffered lidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| buffered lidocaine | Experimental | 4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate. Receives: Drug: buffered lidocaine |
| nonbuffered lidocaine | Active comparator | 4% lidocaine with 1:100,000 epinephrine Receives: Drug: nonbuffered lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)
Measured: pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection
Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.
100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm.
Measured: approximately 15 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Irreversible Pulpitis (Toothache)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Drum, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868776
- Sponsor's protocol ID
- buffered anesthetic toothache
- Status last verified
- Sep 2020
- First submitted
- 30 May 2013
- Last updated
- 6 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
DiFazio CA, Carron H, Grosslight KR, Moscicki JC, Bolding WR, Johns RA. Comparison of pH-adjusted lidocaine solutions for epidural anesthesia. Anesth Analg. 1986 Jul;65(7):760-4.
PubMed 3717616Zahl K, Jordan A, McGroarty J, Sorensen B, Gotta AW. Peribulbar anesthesia. Effect of bicarbonate on mixtures of lidocaine, bupivacaine, and hyaluronidase with or without epinephrine. Ophthalmology. 1991 Feb;98(2):239-42. doi: 10.1016/s0161-6420(91)32311-x.
PubMed 2008283Sinnott CJ, Garfield JM, Thalhammer JG, Strichartz GR. Addition of sodium bicarbonate to lidocaine decreases the duration of peripheral nerve block in the rat. Anesthesiology. 2000 Oct;93(4):1045-52. doi: 10.1097/00000542-200010000-00028.
PubMed 11020760Richtsmeier AJ, Hatcher JW. Buffered lidocaine for skin infiltration prior to hemodialysis. J Pain Symptom Manage. 1995 Apr;10(3):198-203. doi: 10.1016/0885-3924(94)00124-4.
PubMed 7629414Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.
PubMed 16384767Ackerman WE 3rd, Ware TR, Juneja M. The air-liquid interface and the pH and PCO2 of alkalinized local anaesthetic solutions. Can J Anaesth. 1992 Apr;39(4):387-9. doi: 10.1007/BF03009051.
PubMed 1314142
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT01868776
- Acronym / sponsor ID
- buffered anesthetic toothache
- Conditions
- Irreversible Pulpitis (Toothache)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Posted 29 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Patients presenting with toothaches will be given either a buffered numbing solution or a nonbuffered numbing solution. Neither the patient nor the operator will know which solution they will receive. Root canal treatment will be performed on the tooth and the ability of the buffered versus non-buffered numbing solutions will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buffered lidocaine | Experimental | Drug: buffered lidocaine4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate. |
| nonbuffered lidocaine | Active comparator | Drug: nonbuffered lidocaine4% lidocaine with 1:100,000 epinephrine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a diagnosis of irreversible pulpitis (toothache) in a mandibular posterior tooth (back/bottom tooth) with moderate to severe pain
- ages 18 -65 years of age
- in good health (ASA I or II)
- able to grant informed consent.
Key exclusion criteria (6 listed)
- allergy to lidocaine (numbing solution
- significant medical problem (ASA III or IV)
- have taken CNS depressants or analgesic medications within the last 24 hours
- pregnancy or lactating
- non-English speaking
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 |
|---|---|---|
| buffered lidocaine | Drug | buffered lidocaine |
| nonbuffered lidocaine | Drug | nonbuffered lidocaine |
Primary outcome
Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)
Time frame: pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection
Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.
Time frame: approximately 15 minutes after injection
100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3717616DiFazio CA, Carron H, Grosslight KR, Moscicki JC, Bolding WR, Johns RA. Comparison of pH-adjusted lidocaine solutions for epidural anesthesia. Anesth Analg. 1986 Jul;65(7):760-4.
- Background: PubMed 2008283Zahl K, Jordan A, McGroarty J, Sorensen B, Gotta AW. Peribulbar anesthesia. Effect of bicarbonate on mixtures of lidocaine, bupivacaine, and hyaluronidase with or without epinephrine. Ophthalmology. 1991 Feb;98(2):239-42. doi: 10.1016/s0161-6420(91)32311-x.
- Background: PubMed 11020760Sinnott CJ, Garfield JM, Thalhammer JG, Strichartz GR. Addition of sodium bicarbonate to lidocaine decreases the duration of peripheral nerve block in the rat. Anesthesiology. 2000 Oct;93(4):1045-52. doi: 10.1097/00000542-200010000-00028.
- Background: PubMed 7629414Richtsmeier AJ, Hatcher JW. Buffered lidocaine for skin infiltration prior to hemodialysis. J Pain Symptom Manage. 1995 Apr;10(3):198-203. doi: 10.1016/0885-3924(94)00124-4.
- Background: PubMed 16384767Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.
- Background: PubMed 1314142Ackerman WE 3rd, Ware TR, Juneja M. The air-liquid interface and the pH and PCO2 of alkalinized local anaesthetic solutions. Can J Anaesth. 1992 Apr;39(4):387-9. doi: 10.1007/BF03009051.
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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 study testing buffered lidocaine and nonbuffered lidocaine in people with Irreversible Pulpitis (Toothache), run by Ohio State University 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 4 inclusion and 6 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 6 Oct 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2015). 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?
Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia) (time frame: pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection). The study lists 2 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 NCT01868776, which also lists 6 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 6 Oct 2020.