NCT04294745

Brief Summary

This study compares the effectiveness of two techniques of local anesthesia in the extraction of mandibular teeth. One group received inferior alveolar nerve block and the other group received buccal infiltration of 4% Articaine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

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

February 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

March 2, 2020

Last Update Submit

September 28, 2023

Conditions

Keywords

Buccal infiltration inferior alveolar nerve block Articaine

Outcome Measures

Primary Outcomes (3)

  • Pain during injection using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain

    VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 10 (severe pain).

    During injection

  • Pain during extraction using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain

    VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 10 (severe pain).

    During extraction

  • Requirement of rescue injection

    whether a recue injection was given or not

    During extraction

Study Arms (2)

Group A

EXPERIMENTAL

Buccal infiltration of 4% Articaine

Procedure: Buccal infiltration

Group B

ACTIVE COMPARATOR

Inferior alveolar nerve block of 4% Articaine

Procedure: Inferior alveolar nerve block

Interventions

Injection of local anaesthetic parallel to the Long axis of the tooth in the depth of buccal sulcus

Group A

Standard technique of mandibular nerve block

Group B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mandibular teeth
  • grossly decayed teeth
  • root stumps
  • therapeutic extractions
  • American society of anesthesiologist classification I \& II patients

You may not qualify if:

  • patients allergic to local anesthesia
  • infected teeth
  • grade 2 and grade 3 mobile teeth
  • patients already taking medications which influences the anaesthetic assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melaka Manipal Medical College

Malacca, 75150, Malaysia

Location

Study Officials

  • Abdul R Ismail

    Melaka Manipal Medical College

    STUDY DIRECTOR

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
Assistant Professor

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 4, 2020

Study Start

February 1, 2019

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
1 month
Access Criteria
Study protocol will be provided only if requested through a proper channel , dean of the college, with proper justification.

Locations