NCT06766981

Brief Summary

Checking the effectiveness of the infiltration technique of local anesthetic agent as an alternative to inferior dental nerve block during tooth extraction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 9, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

January 4, 2025

Last Update Submit

April 5, 2025

Conditions

Tooth Extraction

Keywords

Local AnesthesiaInferior Dental Nerve BlockInfiltration Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Verbal Pain Rating Scale

    Pain during tooth extraction will be measured immediately after the procedure is completed using a verbal rating scale. The zero rate will be given when the patient feels no pain; the rating degree will increase as the pain severity becomes more severe. According to the following scale: 0 No hurt 1. Slight pain 2. Moderate pain 3. Intense pain 4. Extremely painful

    during the intervention/procedure/surgery

Study Arms (2)

Block

ACTIVE COMPARATOR

This group will receive a conventional inferior alveolar nerve block (IANB) technique with 2% lidocaine with epinephrine (1:80,000) for tooth extraction.

Procedure: Inferior Alveolar Nerve Block

Infiltration

EXPERIMENTAL

This group will receive 4% articaine with 1:100,000 epinephrine as lingual and buccal infiltration for tooth extraction

Procedure: Infiltration with Articain 4%

Interventions

Infiltration with Articain 4%PROCEDURE

The experimental group of patients that are diagnosed for tooth extraction of mandibular 1st. molar will undergo extraction using an infiltration technique for local anaesthesia. In contrast to the conventional group that will receive Inferior alveolar nerve block

Infiltration
Inferior Alveolar Nerve BlockPROCEDURE

This group will receive a conventional inferior alveolar nerve block (IANB) technique with 2% lidocaine with epinephrine (1:80,000) for tooth extraction.

Also known as: Regional Anaesthesia
Block

Eligibility Criteria

Age18 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The systemic condition must be normal.
  • Patient has no cardiovascular, metabolic, or transmitted disease.
  • The patient has a Mandibular 1st. Molar tooth indicated for extraction.
  • The tooth is non-restorable.

You may not qualify if:

  • Chronic cardiovascular condition, metabolic, or infectious disease.
  • Pregnant women.
  • The tooth is restorable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

College of Dentistry, University of Babylon

Hillah, Babylon, 00964, Iraq

Location

College of Dentistry/University of Babylon

Hillah, Babylon, 00964, Iraq

Location

Related Publications (2)

  • Bataineh AB, Nusair YM, Al-Rahahleh RQ. Comparative study of articaine and lidocaine without palatal injection for maxillary teeth extraction. Clin Oral Investig. 2019 Aug;23(8):3239-3248. doi: 10.1007/s00784-018-2738-x. Epub 2018 Nov 12.

    PMID: 30417227BACKGROUND

  • Madden VJ, Kamerman P, Leake HB, Catley MJ, Heathcote LC, Moseley GL. The Sensation and Pain Rating Scale: easy to use, clear to interpret, and responsive to clinical change. medRxiv [Preprint]. 2024 Jan 9:2023.09.08.23295128. doi: 10.1101/2023.09.08.23295128.

    PMID: 37732279BACKGROUND

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The interventional group will undergo tooth extraction under the infiltration anaesthesia technique
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lect.Dr

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 9, 2025

Study Start

January 10, 2025

Primary Completion

February 10, 2025

Study Completion

March 1, 2025

Last Updated

April 9, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Study DATA will be provided on request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
after research publishment
Access Criteria
other researchers

Locations

IR(2)