Buccal Infiltration Inferior Alveolar Nerve Block ArticaineNCT04294745
Comparing Buccal Infiltration and Inferior Alveolar Nerve Block for Extraction of Mandibular Teeth
A study testing Buccal infiltration and Inferior alveolar nerve block in people with Buccal Infiltration Inferior Alveolar Nerve Block Articaine, run by Melaka Manipal Medical College at 1 site in Malaysia.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Buccal Infiltration Inferior Alveolar Nerve Block Articaine
- What is being tested?
- Buccal infiltration and Inferior alveolar nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Feb 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mandibular teeth
- grossly decayed teeth
- root stumps
- therapeutic extractions
- American society of anesthesiologist classification I \& II patients
Who cannot join
- patients allergic to local anesthesia
- infected teeth
- grade 2 and grade 3 mobile teeth
- patients already taking medications which influences the anaesthetic assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Buccal Infiltration and Inferior Alveolar Nerve Block With Articaine for Extraction of Mandibular Teeth- A Randomized Clinical Trial
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
- Being tested
- Buccal infiltration, Inferior alveolar nerve block
- Keywords
- Buccal infiltration inferior alveolar nerve block Articaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal infiltrationProcedure or surgery
Injection of local anaesthetic parallel to the Long axis of the tooth in the depth of buccal sulcus
Inferior alveolar nerve blockProcedure or surgery
Standard technique of mandibular nerve block
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Buccal infiltration of 4% Articaine Receives: Procedure: Buccal infiltration |
| Group B | Active comparator | Inferior alveolar nerve block of 4% Articaine Receives: Procedure: Inferior alveolar nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: During extraction
Requirement of rescue injection
whether a recue injection was given or not
Measured: During extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start1 Feb 2019
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buccal Infiltration Inferior Alveolar Nerve Block ArticaineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melaka Manipal Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdul Kalam Azad, Melaka Manipal Medical College
- Investigators
- Abdul R Ismail, Study director, Melaka Manipal Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294745
- Sponsor's protocol ID
- MMMC/FOD/AR/B7/E C-2019 (04)
- Status last verified
- Sep 2023
- First submitted
- 2 Mar 2020
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Buccal Infiltration and Inferior Alveolar Nerve Block With Articaine for Extraction of Mandibular Teeth- A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04294745
- Acronym / sponsor ID
- MMMC/FOD/AR/B7/E C-2019 (04)
- Keywords
- Buccal infiltration inferior alveolar nerve block Articaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Melaka Manipal Medical CollegeUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Buccal infiltrationBuccal infiltration of 4% Articaine |
| Group B | Active comparator | Procedure: Inferior alveolar nerve blockInferior alveolar nerve block of 4% Articaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mandibular teeth
- grossly decayed teeth
- root stumps
- therapeutic extractions
- American society of anesthesiologist classification I \& II patients
Key exclusion criteria (4 listed)
- patients allergic to local anesthesia
- infected teeth
- grade 2 and grade 3 mobile teeth
- patients already taking medications which influences the anaesthetic assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccal infiltrationInjection of local anaesthetic parallel to the Long axis of the tooth in the depth of buccal sulcus | Procedure or surgery | Group A |
| Inferior alveolar nerve blockStandard technique of mandibular nerve block | Procedure or surgery | Group B |
Primary outcome
Pain during injection using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain
Time frame: During injection
VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 10 (severe pain).
Pain during extraction using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain
Time frame: During extraction
VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 10 (severe pain).
Requirement of rescue injection
Time frame: During extraction
whether a recue injection was given or not
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: Yes
Related trials for Buccal Infiltration Inferior Alveolar Nerve Block Articaine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul R Ismail study director
Melaka Manipal Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal infiltration and Inferior alveolar nerve block in people with Buccal Infiltration Inferior Alveolar Nerve Block Articaine, run by Melaka Manipal Medical College at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during injection using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain (time frame: During injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.