NCT06302907

Brief Summary

The aim of the present study was to evaluate the pain during local anesthetic buccal infiltration for the maxillary canines after adding Sodium Bicarbonate 8.4% during local anesthesia.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 14, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

March 1, 2024

Last Update Submit

March 7, 2024

Conditions

Local Anesthetic Complication

Keywords

Upper canine infiltrationLidocaineSodium bicarbonate

Outcome Measures

Primary Outcomes (1)

  • Pain on injection

    \- Pain was measured on a visual analogue scale (VAS) starting from 0 which represents (no pain at all) and ending with 10 which represents (the most severe pain)

    one week

Study Arms (2)

Buffered LA

ACTIVE COMPARATOR

AA buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site

Procedure: Buffered Local anaesthesiaProcedure: Unbuffered Local anaesthesia

Unbuffered LA

ACTIVE COMPARATOR

an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.

Procedure: Buffered Local anaesthesiaProcedure: Unbuffered Local anaesthesia

Interventions

Buffered Local anaesthesiaPROCEDURE

A buffered 2% lidocaine with 1:80000 epinephrine and sodium bicarbonate 8.4% was used for one site

Buffered LAUnbuffered LA
Unbuffered Local anaesthesiaPROCEDURE

an unbuffered 2% lidocaine with 1: 80000 epinephrine for the other site at the same appointment.

Buffered LAUnbuffered LA

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Caries free with no restorations, periapical lesions, or history of trauma at the site of injection.
  • Willingness to participate in the study and ability to describe and evaluate their pain.
  • No painkillers, or sedatives taken for at least 24 hours so that pain assessment isn't affected.

You may not qualify if:

  • allergy to local anesthetics.
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Wataniya Private University

Hama, Hama Government, 00000, Syria

Location

Study Officials

  • Tarek A Agwa, Senior Lect

    Al Wataniya Private University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 12, 2024

Study Start

January 14, 2023

Primary Completion

September 10, 2023

Study Completion

June 30, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)