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The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block

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ClinicalTrials.gov Identifier: NCT04186299
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Elham Shadmehr, DDS, MS, University of California, San Francisco

Brief Summary:
Articaine/epinephrine and lidocaine/epinephrine are the most common routine local anesthetic agents currently used in dentistry. However, their anesthetic efficacy and pain control in patients with symptomatic irreversible pulpitis via inferior alveolar nerve block is very low. The aim of this study is to investigate the efficacy of clonidine versus articaine/epinpephrine as a local anesthetic agent for a buccal infiltration after IANB administration with lidocaine for (1) successful IANB, (2) hemodynamic stability, and (3) reducing dental anxiety for endodontic treatment in mandibular molars diagnosed with symptomatic irreversible pulpitis.

Condition or disease Intervention/treatment Phase
Symptomatic Irreversible Pulpitis Drug: Clonidine Drug: Articaine Hydrochloride + Epinephrine Phase 4

Detailed Description:
Articaine/epinephrine and lidocaine/epinephrine are the most common routine local anesthetic agents currently used in dentistry. However, their anesthetic efficacy and pain control in patients with symptomatic irreversible pulpitis via inferior alveolar nerve block is very low. The aim of this study is to investigate the efficacy of clonidine versus articaine/epinpephrine as a local anesthetic agent for a buccal infiltration after IANB administration with lidocaine for (1) successful IANB, (2) hemodynamic stability, and (3) reducing dental anxiety for endodontic treatment in mandibular molars diagnosed with symptomatic irreversible pulpitis. 100 patients with first or second mandibular molars diagnosed with symptomatic irreversible pulpitis will be enrolled. Patients will randomly receive either 1.7mL of clonidine (1:100,000) or 1.7mL of 4% articaine with epinephrine (1:100,000) using buccal infiltration technique after administration of 1.7mL of 2% lidocaine with epinephrine (1:100,000) using an IANB technique. 15 minutes after injection, lip numbness will be checked. Those who reported lip numbness will be checked for pulpal anesthesia. Those who achieve profound pulpal anesthesia will be included in the study. Patient's pain score will be recorded using a Heft-Parker visual analog scale before, during and after endodontic treatment. Success in IANB is defined as no or mild pain upon endodontic access cavity preparation and initial canal instrumentation. The hemodynamic parameters and pain management will be measured before and after root canal treatment with specific intervals. Patient's dental anxiety level will be measured by VAS-Anxiety preoperatively, before IANB administration, before endodontic treatment and after the treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Buccal Infiltration Administration of Clonidine on the Success Rate of Inferior Alveolar Nerve Block on Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Clinical Trial
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Experimental: Clonidine
1.7mL of 1:100,000 clonidine
Drug: Clonidine
Each patient will receive a buccal infiltration of 1.7mL of 1:100,000 clonidine.

Active Comparator: articaine/epinephrine
1.7mL of 4% articaine with 1:100,000 epinephrine
Drug: Articaine Hydrochloride + Epinephrine
Each patient will receive a buccal infiltration of 1.7mL of 4% articaine with 1:100,000 epinephrine.




Primary Outcome Measures :
  1. Evaluation of success of IANB [ Time Frame: The pain level is recorded as the extent of access is achieved within dentin and while entering the pulp chamber or during initial file placement. Data of each patient will be recorded through study completion, an average of 4 hours. ]
    The patients will be instructed to rate any pain felt during the procedure. If they feel pain, the treatment will be stopped immediately and they rate their pain using the Heft-Parker Visual Analogue Scale (VAS). The success of the IANB is defined as the ability to penetrate dentin, enter the pulp and advance instruments into the coronal part of the canal pulp without pain or with mild pain. The VAS consists of four categories of scales on a 170mm VAS line. No pain corresponds to 0mm. Mild pain is defined as greater than 0mm and less than or equal to 54mm. Moderate pain is defined as greater 54mm and less than or equal to 114mm. Severe pain is defined as greater than 114mm. At each step, when patients report moderate to severe pain, the IANB is considered to have failed.


Secondary Outcome Measures :
  1. Evaluation of dental anxiety [ Time Frame: The initial measurement is obtained before treatment, and 5 and 30 minutes after administration of anesthesia. Data of each patient are recorded by the end of the visit, which takes an average of 4 hours. ]
    Patients are instructed to rate their dental anxiety level on a VAS-Anxiety. The VAS consists of four categories of scales on a 10cm VAS line. No anxiety corresponds to 0cm. Mild anxiety is defined as greater than 0cm and less than 5.1cm. Moderate anxiety is defined as greater than or equal to 5.1cm and less than 7.0cm. Severe anxiety is defined as greater than or equal to 7.0cm.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be at least 18 years of age;
  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Must be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial (American Society of Anesthesiologists classification 1); and
  • Have a diagnosis of symptomatic irreversible pulpitis and normal or symptomatic apical periodontitis for their mandibular first or second molar.

Exclusion Criteria:

  • Active signs of oral infections or inflammation;
  • History of addiction or use of beta blockers;
  • Use of medications that could affect anesthetic assessment (analgesics or opioids at least one week before treatments);
  • Allergies or contraindications to the use of clonidine, epinephrine or ibuprofen;
  • Pregnant or nursing per subject report;
  • No response to cold testing, periradicular pathosis (other than a widened periodontal ligament), or no vital coronal pulp tissue upon access cavity preparation (partial necrosis);
  • Any diseases or condition that might interfere with the safe participation in the study; and
  • Inability to undergo study procedures

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): NCT04186299


Contacts
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Contact: Daphne Chung 415-349-0773 yoojung.chung@ucsf.edu
Contact: Elham Shadmehr, DDS, MS 415-514-3546 Elham.Shadmehr@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Elham Shadmehr, DDS, MS University of California, San Francisco

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Responsible Party: Elham Shadmehr, DDS, MS, DDS., MS., Assistant Clinical Professor of Preventive & Restorative Dental Science, School of Dentistry, UCSF, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04186299    
Other Study ID Numbers: 19-28605
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Clonidine
Epinephrine
Racepinephrine
Carticaine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Analgesics
Sensory System Agents
Antihypertensive Agents
Sympatholytics
Adrenergic alpha-2 Receptor Agonists
Anesthetics, Local