Combination of Buffered Anesthetic to Treat Mandibular Molars
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| ClinicalTrials.gov Identifier: NCT06047366 |
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Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : May 2, 2024
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Sponsor:
Indiana University
Information provided by (Responsible Party):
Kenneth J. Spolnik DDS, Indiana University
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Brief Summary:
The purpose of this study is to determine whether a combination of anesthetics (numbing medicine) will adequately anesthetize teeth over a different combination. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Symptomatic Irreversible Pulpitis | Drug: Sodium bicarbonate Drug: Lidocaine w/ epi Drug: Articaine w/ epi Drug: Mepivacaine plain | Phase 4 |
60 human subjects with Symptomatic Irreversible Pulpitis (SIP) in mandibular molars will be randomly allocated into 2 groups. One group will receive a combination of: 1 cartridge of buffered 2% lidocaine w/ 1:100k epi via inferior alveolar nerve block (IANB) followed by 1 cartridge of 3% mepivacaine via IANB. This will be followed by 0.5 cartridges (0.9mL) of buffered 4% articaine with 1:100k epi via buccal infiltration and 0.5 cartridges of buffered 4% articaine with 1:100k epi via lingual infiltration. All IANB injections will include a lingual block. The second group will be provided an unbuffered version of the same combination. An electronic pulp tester (EPT) will be used to determine the vitality of the treated tooth. Endodontic treatment will be initiated after two consecutive EPT readings of 80, displaying pulpal anesthesia. Profound pulpal anesthesia is described by the patient's report on the visual analog scale after the pulpotomy.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | This study will be a single-center, controlled, randomized, double-blind (provider and subject), 2 treatment, 1 period, parallel study |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | A statistician will provide a two-product randomization scheme which will randomize each of the 60 subjects on the order of their entry into the study. The research assistants will be aware of and document this scheme, but the student researcher/PI will not know what type of anesthetic will be administered. |
| Primary Purpose: | Treatment |
| Official Title: | Buffered vs Unbuffered Local Anesthesia Using Lidocaine, Carbocaine, and Articaine in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis |
| Actual Study Start Date : | December 5, 2023 |
| Estimated Primary Completion Date : | October 2024 |
| Estimated Study Completion Date : | October 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Buffered
Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
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Drug: Sodium bicarbonate
Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
Other Name: Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solutio Drug: Lidocaine w/ epi Septodont's standard formulation of 2% lidocaine with epinephrine
Other Name: 2% lidocaine with 1:100,000 epinephrine Drug: Articaine w/ epi Septodont's standard formulation of 4% articaine with epinephrine
Other Name: 4% articaine with 1:100,000 epinephrine Drug: Mepivacaine plain Septodont's standard formulation of 3% mepivacaine
Other Name: 3% Mepivacaine |
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Active Comparator: Unbuffered
Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics
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Drug: Lidocaine w/ epi
Septodont's standard formulation of 2% lidocaine with epinephrine
Other Name: 2% lidocaine with 1:100,000 epinephrine Drug: Articaine w/ epi Septodont's standard formulation of 4% articaine with epinephrine
Other Name: 4% articaine with 1:100,000 epinephrine Drug: Mepivacaine plain Septodont's standard formulation of 3% mepivacaine
Other Name: 3% Mepivacaine |
Primary Outcome Measures :
- Visual analogue scale (VAS) Scores as Measures of Profoundness of Pulpal Anesthesia [ Time Frame: Up to 20 minutes post-drug administration ]Patient will report their comfort during treatment based on a VAS graphic. Visual analog scale (VAS) is based on a scale of 1-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment meaning there was inadequate anesthesia.
Secondary Outcome Measures :
- Onset of Pulpal Anesthesia [ Time Frame: Up to 20 minutes post-drug administration ]An electronic pulp tester will be used to assess anesthesia after anesthetic is administered
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Be between the ages of 18 and 80 years old
- Have the ability and willingness to independently consent to treatment and study participation
- Have an uncomplicated medical history (ASA I and II)
- Not be pregnant
- Have no allergies local anesthetics/sulfites (confirmed or self-reported)
- Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours)
- Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data
- Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study
Exclusion Criteria:
- A negative response to cold in the proposed treatment tooth
- A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047366
Contacts
| Contact: Kenneth Spolnik, DDS | 317-274-7280 | kspolnik@iu.edu | |
| Contact: Steven Magura, DDS | 2199297735 | sdmagura@iu.edu |
Locations
| United States, Indiana | |
| ndiana University School of Dentistry Graduate Endodontics Dept. | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Kenneth Spolnik, DDS 317-274-7280 kspolnik@iu.edu | |
| Contact: Steven Magura, DDS 2199297735 sdmagura@gmail.com | |
Sponsors and Collaborators
Indiana University
Investigators
| Study Chair: | Kenneth Spolnik, DDS | Program Director |
Publications:
| Responsible Party: | Kenneth J. Spolnik DDS, Department of Endodontics Chair, Indiana University |
| ClinicalTrials.gov Identifier: | NCT06047366 |
| Other Study ID Numbers: |
17799 |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | May 2, 2024 |
| Last Verified: | December 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Kenneth J. Spolnik DDS, Indiana University:
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lidocaine articaine mepivacaine buffered local anesthetic irreversible pulpitis |
Additional relevant MeSH terms:
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Pulpitis Dental Pulp Diseases Tooth Diseases Stomatognathic Diseases Lidocaine Epinephrine Racepinephrine Carticaine Mepivacaine Epinephryl borate Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents |
Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents |