NCT05223075

Brief Summary

assess the effect of articaine versus lidocaine in only buccal infiltration of local anethesia in lower anterior teeth

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 23, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

January 23, 2022

Last Update Submit

February 14, 2023

Conditions

Pain

Keywords

buccal infiltrationlidocainearticaine

Outcome Measures

Primary Outcomes (1)

  • pain during extraction

    by (VAS) visual analouge scale

    during extraction

Study Arms (2)

articaine group

EXPERIMENTAL
Drug: articaine local anethesia with vasoconstrictor

lidocaine group

EXPERIMENTAL
Drug: lidocaine local anethesia with vasoconstrictor

Interventions

articaine local anethesia with vasoconstrictorDRUG

buccal infiltration only of articaine local anethesia during extraction of lower anterior teeth

articaine group
lidocaine local anethesia with vasoconstrictorDRUG

buccal infiltration only of lidocaine local anethesia during extraction of lower anterior teeth

lidocaine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • medically stable
  • years or older
  • patient with bilateral lower anterior teeth requiring non surgical removal

You may not qualify if:

  • grade 3 mobility
  • neurological disease
  • allergy to anethesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

Related Publications (1)

  • Al-Mahalawy H, El-Mahallawy Y, Abdelrahman HH, Refahee SM. Articaine versus Lidocaine in only buccal infiltration anesthesia for the extraction of mandibular anterior teeth. A prospective split-mouth randomized-controlled clinical study. BMC Oral Health. 2023 Aug 28;23(1):604. doi: 10.1186/s12903-023-03292-5.

    PMID: 37641122DERIVED

MeSH Terms

Conditions

Pain

Interventions

Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

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
PRINCIPAL INVESTIGATOR
PI Title
lecturer of oral and maxillofaciall surgery

Study Record Dates

First Submitted

January 23, 2022

First Posted

February 3, 2022

Study Start

November 11, 2022

Primary Completion

February 28, 2023

Study Completion

March 2, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

EG(1)