Buccal InfiltrationNCT06630819
Buccal Infiltration of Different Volumes of Articaine for Extraction.
A study testing 1.8 ml of 4% Articaine and 3.6 ml of 4% Articaine in people with Buccal Infiltration and Articaine, run by Qassim University at 2 sites in Saudi Arabia.
Trial summary
This study compares the effectiveness of two different volumes of buccal infiltration of Articaine for the extraction of mandibular posterior teeth. One group receives buccal infiltration of 1.8 ml of 4% Articaine and the other group receives buccal infiltration of 3.6 ml of 4% Articaine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Buccal Infiltration, Articaine, Anesthesia
- What is being tested?
- 1.8 ml of 4% Articaine and 3.6 ml of 4% Articaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 24 Nov 2024to 2 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II)
- Patients aged ≥ 18 years of age.
- Patients requiring extraction of mandibular posterior teeth including grossly decayed tooth, grade I mobile tooth, root stumps and indicated for therapeutic reasons.
- Patients not allergic to the drugs or anesthetic agents used in the surgery.
Who cannot join
- Acute infection at the extraction site.
- Patients indicated for surgical extraction of teeth.
- Patients already taking medications affecting pain assessment.
- Pregnant patients.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia2 sites, 2 recruiting
- Not yet recruiting
Qassim University
Buraidah, Al Qassim, 52719
Muhammad Atif S Agwan, 966-541651713, m.abdulsaleem@qu.edu.sa
Abdullah Ahmad A Aloyouni
- Recruiting
College of Dentistry, Qassim University
Buraidah, 52385
Muhammad Atif Agwan, 00966541651713, m.abdulsaleem@qu.edu.sa
About this study
Official title: Comparing the Effectiveness of Buccal Infiltration of Different Volumes of Articaine for Extraction of Mandibular Posterior Teeth- A Randomized Clinical Trial.
This study compares the effectiveness of two different volumes of buccal infiltration of Articaine for the extraction of mandibular posterior teeth. One group receives buccal infiltration of 1.8 ml of 4% Articaine and the other group receives buccal infiltration of 3.6 ml of 4% Articaine.
Read the detailed description
The most widely and commonly used injection method for the extraction of mandibular posterior teeth is the inferior alveolar nerve block (IANB) technique. However, various complications like pain during injection, transient facial nerve paralysis, trismus, hematoma, and paresthesia are associated with the inferior alveolar nerve block technique.
Local infiltration technique has been proven as a safer and less painful anesthetic injection technique compared to IANB. Unfortunately, the dense nature of cortical bone in the mandibular posterior region hinders sufficient diffusion of anesthetic solution during infiltration. Thus, to achieve an adequate anesthesia for a painless dental extraction of mandibular posterior teeth by infiltration technique, a strong and effective local anesthetic agent having a deeper penetrating property should be used.
Articaine is one of the most widely used local anesthetic agents. It is more potent and has shown more success rate than Lidocaine and Mepivacaine in providing anesthesia in mandibular and maxillary posterior teeth by buccal infiltration diffusibility.
This study compares the effectiveness of two different volumes of buccal infiltration of Articaine for the extraction of mandibular posterior teeth.
- Conditions
- Buccal Infiltration, Articaine, Anesthesia
- Being tested
- 1.8 ml of 4% Articaine, 3.6 ml of 4% Articaine
- Keywords
- Buccal infiltration, Articaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.8 ml of 4% ArticaineOther
Buccal infiltration of 1.8 ml of 4% Articaine
3.6 ml of 4% ArticaineOther
Buccal infiltration of 3.6 ml of 4% Articaine.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Buccal infiltration of 3.6 ml of 4% Articaine Receives: Other: 3.6 ml of 4% Articaine |
| Group B | Active comparator | Buccal infiltration of 1.8 ml of 4% Articaine Receives: Other: 1.8 ml of 4% Articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 100 (severe pain).
Measured: From reflection of mucoperiosteum till delivery of tooth out of socket.
Time of onset of anesthesia
It will be assessed by probing buccal and lingual soft tissue using a dental explorer every 2 minutes after infiltration using a standard digital stop clock.
Measured: upto 10 minutes
Presence or absence of pain
A 100 mm Numerical rating scale assessing intraoperative pain. Possible score ranges from 0 (no pain) to 100 (worst possible pain).
Measured: From reflection of mucoperiosteum till delivery of tooth out of socket.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start24 Nov 2024
- Primary completion2 May 2026 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buccal InfiltrationStudies 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
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Atif Saleem Agwan, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630819
- Sponsor's protocol ID
- 608/45/14624
- Status last verified
- May 2025
- First submitted
- 24 Sep 2024
- Last updated
- 29 May 2025
- 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 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Buccal Infiltration of Different Volumes of Articaine for Extraction of Mandibular Posterior Teeth- A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06630819
- Acronym / sponsor ID
- 608/45/14624
- Conditions
- Buccal Infiltration, Articaine, Anesthesia
- Keywords
- Buccal infiltration, Articaine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 2 May 2026 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 8 Oct 2024 (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 different volumes of buccal infiltration of Articaine for the extraction of mandibular posterior teeth. One group receives buccal infiltration of 1.8 ml of 4% Articaine and the other group receives buccal infiltration of 3.6 ml of 4% Articaine.
Detailed description
The most widely and commonly used injection method for the extraction of mandibular posterior teeth is the inferior alveolar nerve block (IANB) technique. However, various complications like pain during injection, transient facial nerve paralysis, trismus, hematoma, and paresthesia are associated with the inferior alveolar nerve block technique.
Local infiltration technique has been proven as a safer and less painful anesthetic injection technique compared to IANB. Unfortunately, the dense nature of cortical bone in the mandibular posterior region hinders sufficient diffusion of anesthetic solution during infiltration. Thus, to achieve an adequate anesthesia for a painless dental extraction of mandibular posterior teeth by infiltration technique, a strong and effective local anesthetic agent having a deeper penetrating property should be used.
Articaine is one of the most widely used local anesthetic agents. It is more potent and has shown more success rate than Lidocaine and Mepivacaine in providing anesthesia in mandibular and maxillary posterior teeth by buccal infiltration diffusibility.
This study compares the effectiveness of two different volumes of buccal infiltration of Articaine for the extraction of mandibular posterior 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 | Other: 3.6 ml of 4% ArticaineBuccal infiltration of 3.6 ml of 4% Articaine |
| Group B | Active comparator | Other: 1.8 ml of 4% ArticaineBuccal infiltration of 1.8 ml of 4% Articaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II)
- Patients aged ≥ 18 years of age.
- Patients requiring extraction of mandibular posterior teeth including grossly decayed tooth, grade I mobile tooth, root stumps and indicated for therapeutic reasons.
- Patients not allergic to the drugs or anesthetic agents used in the surgery.
Key exclusion criteria (4 listed)
- Acute infection at the extraction site.
- Patients indicated for surgical extraction of teeth.
- Patients already taking medications affecting pain assessment.
- Pregnant patients.
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 |
|---|---|---|
| 1.8 ml of 4% ArticaineBuccal infiltration of 1.8 ml of 4% Articaine | Other | Group B |
| 3.6 ml of 4% ArticaineBuccal infiltration of 3.6 ml of 4% Articaine. | Other | Group A |
Primary outcome
Intensity of pain
Time frame: From reflection of mucoperiosteum till delivery of tooth out of socket.
VAS scale is a validated scale measuring pain with possible score range from 0 (no pain) to 100 (severe pain).
Time of onset of anesthesia
Time frame: upto 10 minutes
It will be assessed by probing buccal and lingual soft tissue using a dental explorer every 2 minutes after infiltration using a standard digital stop clock.
Presence or absence of pain
Time frame: From reflection of mucoperiosteum till delivery of tooth out of socket.
A 100 mm Numerical rating scale assessing intraoperative pain. Possible score ranges from 0 (no pain) to 100 (worst possible pain).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1.8 ml of 4% Articaine and 3.6 ml of 4% Articaine in people with Buccal Infiltration and Articaine, run by Qassim University at 2 sites in Saudi Arabia.
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 4 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: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Atif S Agwan (966541651713, m.abdulsaleem@qu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: From reflection of mucoperiosteum till delivery of tooth out of socket.). 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 29 May 2025.