Efficacy of Buprenorphine on Postoperative Endodontic Analgesia

NCT ID: NCT03268278

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

buprenorphine and local anesthetic

buprenorphine added to local anesthetic

Group Type ACTIVE_COMPARATOR

Buprenorphine

Intervention Type DRUG

Buprenorphine plus local anesthetic

lidocaine, epinephrine (Local anesthetic)

Intervention Type DRUG

2% lidocaine 1:100,000 epinephrine

sterile saline and local anesthetic

sterile saline (placebo) added to local anesthetic

Group Type PLACEBO_COMPARATOR

Sterile saline

Intervention Type DRUG

Placebo 1,8 ml

lidocaine, epinephrine (Local anesthetic)

Intervention Type DRUG

2% lidocaine 1:100,000 epinephrine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Buprenorphine

Buprenorphine plus local anesthetic

Intervention Type DRUG

Sterile saline

Placebo 1,8 ml

Intervention Type DRUG

lidocaine, epinephrine (Local anesthetic)

2% lidocaine 1:100,000 epinephrine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* persons with preoperative pain to percussion of a tooth with pulpal disease requiring endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the drugs being administered

Exclusion Criteria

* pregnancy, allergy to buprenorphine, allergy to local anesthetic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thomas A. Montagnese

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UHClevelandMCBupStudy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Methadone in Ambulatory Surgery
NCT02300077 COMPLETED NA
NSAIDS vs Opioids in Tibial Fractures
NCT05332314 UNKNOWN PHASE4