NCT07048834

Brief Summary

In this study 60 adult patients will participate and divided into two groups (30 for each). The first group will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, while the second group will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration technique in posterior teeth area. Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin. After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction. Female patients who are breastfeeding or pregnant, those allergic to local anesthetics, lacking full mental ability, currently taking opioids, having an infection at the extraction site, or those under the influence of medicines that alter their perception of pain will be excluded from the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

11 months

First QC Date

May 21, 2025

Last Update Submit

July 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • visual analog scale (VAS)

    It usually is a horizontal line, 100 mm in length, anchored by word descriptors at each end, for example, that represent the severity of symptoms from 0 "no symptoms" to 10 "very severe symptoms." The patient marks on the line the point that the patient believes represents his or her perception of his or her current state.

    five minutes

Study Arms (2)

patients anesthetized by 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block.

OTHER

This group of (30 patients) will be anesthetized using 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block technique, Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin. After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction

Other: lidocaine local anesthetic drug

anesthetized by 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration.

OTHER

This group (of 30 patients) will be anesthetized using 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration technique in posterior teeth area. Then patients will wait for five minutes after receiving a local anesthetic injection before extraction could begin. After that every tooth's buccal, lingual, mesial, and distal surfaces will be examined using a disposable dental explorer. Then by visual analog scale (VAS) which provides accessible, sensitive, valid, and reliable means to measure a variety of subjective parameters the pain score will be registered during tooth extraction.

Other: articaine local anesthetic drug

Interventions

Lidocaine Nerve Block technique

patients anesthetized by 2 % lidocaine with 1:80,000 adrenaline by inferior alveolar nerve block.

Articaine Local Infusion technique

anesthetized by 4 % articaine with 1:100,000 adrenaline via buccal and lingual infiltration.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinically healthy patients

You may not qualify if:

  • Breastfeeding or pregnant
  • Allergic to local anaesthetics drugs
  • Lack full mental ability
  • Infection at the extraction site
  • Patient who currently taking opioids or under the influence of medicines that alter their perception of pain are not candidates for tooth extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahl Al Bayt University

Karbala, Iraq

Location

Related Publications (1)

  • Webster S Jr, Drum M, Reader A, Fowler S, Nusstein J, Beck M. How Effective Is Supplemental Intraseptal Anesthesia in Patients with Symptomatic Irreversible Pulpitis? J Endod. 2016 Oct;42(10):1453-7. doi: 10.1016/j.joen.2016.07.002.

    PMID: 27663614BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

May 21, 2025

First Posted

July 3, 2025

Study Start

March 15, 2021

Primary Completion

February 20, 2022

Study Completion

May 17, 2022

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Due to lack of participant consent for data Sharing. so, Individual participant data will not be shared due to the absence of specific provisions for broad external data sharing within the original informed consent documents signed by participants. Retrospective consent for such sharing is not feasible for this study population.

Locations