Completed

Comparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial

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What is being tested

Lidocaine

+ Bupivacaine

Drug
Who is being recruted

Inflammation+3

+ Neurologic Manifestations

+ Pain

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 4
Interventional
Study Start: July 2008
See protocol details

Summary

Principal SponsorUniversity of Maryland
Last updated: January 27, 2026
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Study start date: July 1, 2008

Actual date on which the first participant was enrolled.

We hypothesize that the use of the LLA bupivacaine will promote local inflammation leading to increased pain and central sensitization as evaluated by increase in pain at later time points. Hence our main hypothesis to be evaluated and statistically tested for our primary endpoint (Aim 1) is: HO: There is no difference in mean levels of biochemical mediators of inflammation between groups. HA: The bupivacaine group has higher levels of biochemical mediators following surgery.

Official TitleComparison of Bupivacaine vs Lidocaine on Inflammatory Regulation Following Endodontic Surgery: A Double-Blind, Randomized, Controlled Clinical Trial
NCT01060774
Principal SponsorUniversity of Maryland
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InflammationNeurologic ManifestationsPainPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate
Male or female volunteers referred for endodontic surgery willing to undergo 2 visits: 1 surgical appointment, and 1 follow-up research-related appointment
Ages of 18 and older
Willing to undergo observation for 1/2 hour post-operatively
Willing to complete a 100 mm visual analog scale and record analgesic intake over 48 hrs period
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5 exclusion criteria prevent from participating
Allergy to or other contraindications to use of aspirin, sulfites, amide anesthetics, or acetaminophen
Chronic use of medications confounding the assessment of the inflammatory response or analgesia, for example, NSAIDS, COX-2 inhibitors, antihistamines, steroids, antidepressants
Medications contraindicated with bupivacaine: MAO inhibitors and anti-depressants
Diseases such as diabetes mellitus, liver disease, chronic infections, rheumatoid arthritis or any other systemic disease that compromises the immune system
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
2% lidocaine/1:200,000 epinephrine

Group II

Experimental
0.5% bupivacaine/1:200,000 epinephrine

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Maryland, Baltimore College of Dental Surgery

Baltimore, United StatesOpen University of Maryland, Baltimore College of Dental Surgery in Google Maps
CompletedOne Study Center