NCT06538233

Brief Summary

Pain after buffered versus non buffered articaine.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

August 5, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

July 17, 2024

Last Update Submit

July 31, 2024

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Numerical Rate Scale (NRS)

    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

Study Arms (2)

Buffered articaine

EXPERIMENTAL
Drug: Buffered articaine

non buffered articaine

ACTIVE COMPARATOR
Drug: Non buffered articaine

Interventions

Buffered articaineDRUG

Injecting buffered articaine in maxillary anterior region and evaluate pain response.

Buffered articaine
Non buffered articaineDRUG

Injecting non buffered articaine in maxillary anterior region and evaluate pain response.

non buffered articaine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clevland Dental Institute

Cleveland, Ohio, 44128, United States

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed H Khalifa, PhD

    Cleveland Dental Institute

    STUDY CHAIR

  • Waleed Elmallah, PhD

    Cleveland Dental Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavanpreet Kaur, Resident

CONTACT

2163551155p.kaur@cdiohio.org

Jana Aboul-Hassan, Resident

CONTACT

7262054266j.aboulhassan@cdiohio.org

Study Design

Study Type
interventional
Phase
phase 2
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

July 17, 2024

First Posted

August 5, 2024

Study Start

January 1, 2024

Primary Completion

October 31, 2024

Study Completion

January 31, 2025

Last Updated

August 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)