Drug EffectPhase 2IANBNCT05840913
Different Volumes of Articaine for Inferior Alveolar Nerve Block in Irreversible Pulpitis
A Phase 2 study testing Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge in people with Drug Effect and Pulpitis - Irreversible, run by Armed Forces Institute of Dentistry, Pakistan at 2 sites in Pakistan.
Trial summary
This is a randomized controlled trial comparing the anaesthetic efficacy of 1.8 and 3.6 mL of Articaine for inferior alveolar nerve block when treating mandibular molars with Irreversible Pulpitis Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Effect, Pulpitis - Irreversible
- What is being tested?
- Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Dec 2023to 31 Jul 2024
- Phase
- Phase 2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients, including age group 18-55 years old
- Mandibular first molar tooth with symptomatic irreversible pulpitis
- Normal periapical radiographic appearance
- Moderate pain on Heft-Parker VAS ( > 54 mm and < 114 mm )
- Lingering pain or prolonged response to the cold testing (more than 10 seconds)
- Positive response to electric pulp testing
Who cannot join
- Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit
- History of allergy to 4% articaine or epinephrine
- Patients with systemic diseases
- Pregnant or lactating patients
- Teeth with severe periodontal disease
- Teeth with periapical radiolucency
- Any type of medication that could potentially interact with the anesthetic solution (antihypertensives)
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Armed Forces Institue Of Dentistry
Rawalpindi, Punjab Province, 46000
Armed Forces Institute of Dentistry
Rawalpindi, Punjab Province, 46000
About this study
Official title: Comparison of Anaesthetic Effectiveness of Different Volumes of Articaine for Inferior Alveolar Nerve Block in Molar Teeth with Symptomatic Irreversible Pulpitis
This is a randomized controlled trial comparing the anaesthetic efficacy of 1.8 and 3.6 mL of Articaine for inferior alveolar nerve block when treating mandibular molars with Irreversible Pulpitis
Read the detailed description
An informed written consent of the patients will be obtained. (Annex-A).
Demographic details (including name, age, gender, contact) will be obtained on data collection forms. (Annex-B).
The principal investigator will perform the local anesthetic injection and the participants will be assigned to one of the groups.
Group 1: 1.8 mL articaine Group 2: 3.6 mL articaine
Before starting the treatment i.e. before administration of the anesthetic solution, each participant will receive an explanation regarding the Heft-Parker visual analog pain scale (VAS) and asked to rate their pain on a self-report questionnaire.
A topical anesthetic gel (20% Benzocaine; Premier, Philadelphia, PA) will passively placed at the injection site with a cotton tip applicator for 1 minute before injection.
A conventional IANB will administered using an aspirating syringe with a side-loading cartridge system (Dena Instruments; Forgeman Instruments Co, Sialkot, Pakistan) and a 27-G 31-mm needle (C-K ject; CK Dental, Kor-Kyungji-do, Korea).
All injections will be given by one clinician in both groups. Group 2 participants will receive 2 cartridges of the anesthetic solution and group 1 will receive a cartridge of the anesthetic solution followed by a mock injection.
The rest of the procedure will be performed by a second investigator. Ten minutes after injection, the participants will be asked whether they have lip numbness. Any patient without lip numbness at this stage will excluded from study.
Fifteen minutes after the administration of the IANB, the teeth will be re-evaluated with electric pulp testing. On positive response, participants will be again asked to rate their pain using the VAS on the questionnaire.
If higher than mild pain is reported, supplemental anesthesia (intraperiodontal ligament or intrapulpal injection) will be used to provide patient comfort throughout the treatment.
Then teeth under study will be isolated with a rubber dam, and caries removed followed by the preparation of an endodontic access cavity. The participants will be informed to stop the practitioner at any stage of treatment if they feel more than mild pain by raising their hand.
At the end of each stage of treatment (access cavity preparation, pulp chamber opening, root canal instrumentation), the practitioner will stop work and ask the participants to rate their pain if they do not raise their hand during treatment.
The success will be defined as the ability to undertake pulp access and canal instrumentation with no or mild pain whereas moderate or severe pain will considered as failure of anesthesia.
- Conditions
- Drug Effect, Pulpitis - Irreversible
- Being tested
- Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental CartridgeDrug
Also called Orabloc 4% Articaine 1:100,000 1.8 ml
Local anesthetic injection for intra- operative pain control
| Study group | Role | What they receive |
|---|---|---|
| 1.8 ml group | Experimental | Participants in this group will be given 1 cartridge of articaine solution pre-operatively to endodontic treatment Receives: Drug: Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge |
| 3.6 ml group | Experimental | Participants in this group will be given 2 cartridges of articaine solution pre-operatively to endodontic treatment Receives: Drug: Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Control
Pain was recorded on a self-report questionnaire using the visual analog pain scale (VAS) VAS was used for gauging pain before the administration of the anesthetic solution, after the cold test was performed, and during the endodontic therapy.
The VAS scores were designated as; 0= no pain 1-3= mild pain 4-7= moderate pain 8-10= severe pain
Measured: 30 to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Dec 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kanza Zafar, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Kanza Zafar, BDS, Principal investigator, AFID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840913
- Sponsor's protocol ID
- Articaine Efficacy for IANB
- Acronym
- IANB
- Status last verified
- Oct 2024
- First submitted
- 9 Apr 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anaesthetic Effectiveness of Different Volumes of Articaine for Inferior Alveolar Nerve Block in Molar Teeth with Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05840913
- Acronym / sponsor ID
- IANB / Articaine Efficacy for IANB
- Conditions
- Drug Effect, Pulpitis - Irreversible
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 3 May 2023 (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 is a randomized controlled trial comparing the anaesthetic efficacy of 1.8 and 3.6 mL of Articaine for inferior alveolar nerve block when treating mandibular molars with Irreversible Pulpitis
Detailed description
An informed written consent of the patients will be obtained. (Annex-A).
Demographic details (including name, age, gender, contact) will be obtained on data collection forms. (Annex-B).
The principal investigator will perform the local anesthetic injection and the participants will be assigned to one of the groups.
Group 1: 1.8 mL articaine Group 2: 3.6 mL articaine
Before starting the treatment i.e. before administration of the anesthetic solution, each participant will receive an explanation regarding the Heft-Parker visual analog pain scale (VAS) and asked to rate their pain on a self-report questionnaire.
A topical anesthetic gel (20% Benzocaine; Premier, Philadelphia, PA) will passively placed at the injection site with a cotton tip applicator for 1 minute before injection.
A conventional IANB will administered using an aspirating syringe with a side-loading cartridge system (Dena Instruments; Forgeman Instruments Co, Sialkot, Pakistan) and a 27-G 31-mm needle (C-K ject; CK Dental, Kor-Kyungji-do, Korea).
All injections will be given by one clinician in both groups. Group 2 participants will receive 2 cartridges of the anesthetic solution and group 1 will receive a cartridge of the anesthetic solution followed by a mock injection.
The rest of the procedure will be performed by a second investigator. Ten minutes after injection, the participants will be asked whether they have lip numbness. Any patient without lip numbness at this stage will excluded from study.
Fifteen minutes after the administration of the IANB, the teeth will be re-evaluated with electric pulp testing. On positive response, participants will be again asked to rate their pain using the VAS on the questionnaire.
If higher than mild pain is reported, supplemental anesthesia (intraperiodontal ligament or intrapulpal injection) will be used to provide patient comfort throughout the treatment.
Then teeth under study will be isolated with a rubber dam, and caries removed followed by the preparation of an endodontic access cavity. The participants will be informed to stop the practitioner at any stage of treatment if they feel more than mild pain by raising their hand.
At the end of each stage of treatment (access cavity preparation, pulp chamber opening, root canal instrumentation), the practitioner will stop work and ask the participants to rate their pain if they do not raise their hand during treatment.
The success will be defined as the ability to undertake pulp access and canal instrumentation with no or mild pain whereas moderate or severe pain will considered as failure of anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.8 ml group | Experimental | Drug: Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental CartridgeParticipants in this group will be given 1 cartridge of articaine solution pre-operatively to endodontic treatment |
| 3.6 ml group | Experimental | Drug: Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental CartridgeParticipants in this group will be given 2 cartridges of articaine solution pre-operatively to endodontic treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy patients, including age group 18-55 years old
- Mandibular first molar tooth with symptomatic irreversible pulpitis
- Normal periapical radiographic appearance
- Moderate pain on Heft-Parker VAS ( > 54 mm and < 114 mm )
- Lingering pain or prolonged response to the cold testing (more than 10 seconds)
Key exclusion criteria (7 listed)
- Patients who have taken analgesic or anti-inflammatory drugs within 6 hours before treatment visit
- History of allergy to 4% articaine or epinephrine
- Patients with systemic diseases
- Pregnant or lactating patients
- Teeth with severe periodontal disease
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 |
|---|---|---|
| Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental CartridgeAlso: Orabloc 4% Articaine 1:100,000 1.8 mlLocal anesthetic injection for intra- operative pain control | Drug | 1.8 ml group, 3.6 ml group |
Primary outcome
Pain Control
Time frame: 30 to 45 minutes
Pain was recorded on a self-report questionnaire using the visual analog pain scale (VAS) VAS was used for gauging pain before the administration of the anesthetic solution, after the cold test was performed, and during the endodontic therapy. The VAS scores were designated as; 0= no pain 1-3= mild pain 4-7= moderate pain 8-10= severe pain
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 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Kanza Zafar, BDS principal investigator
AFID
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Articaine HCl 4 % / EPINEPHrine 1:100,000 in 1.8 mL Dental Cartridge in people with Drug Effect and Pulpitis - Irreversible, run by Armed Forces Institute of Dentistry, Pakistan at 2 sites in Pakistan.
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 6 inclusion and 7 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 15 Oct 2024. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Control (time frame: 30 to 45 minutes). 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 15 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.