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

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04186299

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Evaluation of success of IANB [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

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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Elham Shadmehr, DDS, MS, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04186299

Other Study ID Numbers:

19-28605

First Posted:

Dec 4, 2019

Last Update Posted:

Jun 16, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2021