Pain After Buffered Vs Non Buffered Articaine

July 31, 2024 updated by: Cleveland Dental Institute

A Comparison of Pain Response During Administration of Buffered Articaine Versus Non-buffered Articaine Local Anesthetics for Dental Treatment in Adult

Pain after buffered versus non buffered articaine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44128
        • Recruiting
        • Clevland Dental Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males and females, age- 18 to 60 yrs.
  • Medically free.
  • Need a dental treatment in the upper anterior region.

Exclusion Criteria:

  • Periodontally affected teeth.
  • Radiographic bone loss.
  • Upnormal length of the teeth.

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buffered articaine
Drug: Buffered articaine
Injecting buffered articaine in maxillary anterior region and evaluate pain response.
Active Comparator: non buffered articaine
Drug: Non buffered articaine
Injecting non buffered articaine in maxillary anterior region and evaluate pain response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rate Scale (NRS)
Time Frame: Immediate
Pain during injection of buffered versus non-buffered articaine local anesthetic will be measured using NRS from 0 to 10, where 0 is no pain and 10 is the most unbearable pain .
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Dental Institute

Investigators

  • Study Chair: Ahmed H Khalifa, PhD, Cleveland Dental Institute
  • Principal Investigator: Waleed Elmallah, PhD, Cleveland Dental Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Estimated)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDIOS00010

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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