ClinicalTrials.gg
CompletedNCT04294745Updated Oct 2, 2023

Comparing Buccal Infiltration and Inferior Alveolar Nerve Block for Extraction of Mandibular Teeth

An interventional study of Buccal infiltration and Inferior alveolar nerve block in Buccal Infiltration Inferior Alveolar Nerve Block Articaine, sponsored by Melaka Manipal Medical College. Completed at 1 site in Malaysia. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-02.

Sponsored by Melaka Manipal Medical College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Feb 2019, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the detailed description

Inferior alveolar nerve block is the commonly used local anesthetic injection technique for extraction of mandibular teeth. Buccal infiltration technique alone is considered to be ineffective in treating mandibular teeth due to the thickness of buccal cortical plate. However, buccal infiltration, if provided with an agent with higher penetration capability, may be used instead of Inferior alveolar nerve block. Articaine, due to its thiophene ring, has higher liposolubility and bony diffusion than any other agent.

This study compares the effectiveness of inferior alveolar nerve block and buccal infiltration using 4% Articaine in the extraction of mandibular teeth

02

Conditions studied

  • Buccal Infiltration Inferior Alveolar Nerve Block Articaine

Keywords

  • Buccal infiltration inferior alveolar nerve block Articaine
03

In context

Lead sponsor

Melaka Manipal Medical College is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mandibular teeth
  • grossly decayed teeth
  • root stumps
  • therapeutic extractions
  • classification I \& II patients

Exclusion criteria

Exclusion Criteria:

  • patients allergic to local anesthesia
  • infected teeth
  • grade 2 and grade 3 mobile teeth
  • patients already taking medications which influences the anaesthetic assessment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Group A

    Buccal infiltration of 4% Articaine

    Procedure: Buccal infiltration

  • Active comparator
    Group B

    Inferior alveolar nerve block of 4% Articaine

    Procedure: Inferior alveolar nerve block

Interventions

  • ProcedureBuccal infiltration

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

  • ProcedureInferior alveolar nerve block

    Standard technique of mandibular nerve block

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: During injection

  2. 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).

    Time frame: During extraction

  3. Requirement of rescue injection

    whether a recue injection was given or not

    Time frame: During extraction

07

Study locations

1 site
  • Melaka Manipal Medical College
    Melaka, 75150, Malaysia
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04294745
Lead sponsor
Melaka Manipal Medical College
Responsible party
Abdul Kalam Azad (Assistant Professor, Melaka Manipal Medical College) — Principal investigator
First posted
Mar 4, 2020
Start date
Feb 1, 2019
Primary completion
Jan 30, 2020
Completion
Jan 30, 2020
Last update
Oct 2, 2023

Study contacts

Abdul R Ismail
study director · Melaka Manipal Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion