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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Symptomatic Irreversible Pulpitis
• Intervention / Treatment: Drug: Clonidine; Drug: Articaine Hydrochloride + Epinephrine

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 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 (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;
• Any diseases or condition that might interfere with the safe participation in the study; and
• Inability to undergo study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clonidine + articaine/epinephrine; 1.7mL of 4% articaine/epinephrine(1:100,000) + clonidine (15ug/ml)	Drug: Clonidine; Each patient will receive a buccal infiltration of 1.7mL of 1:100,000 clonidine.; Drug: Articaine Hydrochloride + Epinephrine; Each patient will receive a buccal infiltration of 1.7mL of 4% articaine with 1:100,000 epinephrine.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of success of IANB	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of dental anxiety	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.	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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Sympatholytics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Clonidine; Carticaine
• Other Study ID Numbers: 19-28605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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