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

NCT04186299 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 19-28605
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of dental anxiety

  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.

Study Arms (2)

Clonidine + articaine/epinephrine

EXPERIMENTAL

1.7mL of 4% articaine/epinephrine(1:100,000) + clonidine (15ug/ml)

Drug: Clonidine; Drug: Articaine Hydrochloride + Epinephrine

articaine/epinephrine

ACTIVE COMPARATOR

1.7mL of 4% articaine with 1:100,000 epinephrine

Drug: Articaine Hydrochloride + Epinephrine

Interventions

Clonidine DRUG

Each patient will receive a buccal infiltration of 1.7mL of 1:100,000 clonidine.

Clonidine + articaine/epinephrine

Articaine Hydrochloride + Epinephrine DRUG

Each patient will receive a buccal infiltration of 1.7mL of 4% articaine with 1:100,000 epinephrine.

Clonidine + articaine/epinephrine; articaine/epinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Interventions

Clonidine; Carticaine; Epinephrine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Sulfur Compounds; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Elham Shadmehr, DDS, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 4, 2019
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share