Success of Inferior Alveolar Nerve BlockPhase 2NCT06806202
Warm Versus Conventional 2% Lignocaine for IANB Efficacy
A Phase 2 study testing conventional 2% lignocaine at room temperature and pre-warmed 2% lignocaine at 42°C in people with Success of Inferior Alveolar Nerve Block and Inferior Alveolar Nerve Block, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
The study compares the anesthetic efficacy of warm versus conventional 2% lignocaine for inferior alveolar nerve block in mandibular molars, evaluating success rates and onset time. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Success of Inferior Alveolar Nerve Block, Inferior Alveolar Nerve Block
- What is being tested?
- conventional 2% lignocaine at room temperature and pre-warmed 2% lignocaine at 42°C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Dec 2024to 15 Mar 2025
- Phase
- Phase 2
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
- Patient who have carious mandibular molars.
- Patients of either gender aged between 18-50 years old.
- Systemically healthy patients.
- Patients who agree to attend for recall appointments and provide a written consent
Who cannot join
- Patients on preoperative analgesics and antibiotics.
- Teeth with calcified canals and previously treated teeth.
- Pregnant and lactating mothers.
- Patients who are immunocompromised, anxious and mentally handicapped.
- Patients who are allergic to lignocaine.
- Non-vital or necrosed teeth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Forces Institute Of Dentistry
Rawalpindi, Punjab Province, 46000
Maha Ali Mirza, BDS, 00923337808809, mahaalimirza5@gmail.com
Kanza Zafar, BDS, 00923337808809, kanzazafar6@gmail.com
About this study
Official title: Comparative Evaluation of Anesthetic Efficacy of Warm and Conventional 2% Lignocaine for the Success of Inferior Alveolar Nerve Block (IANB) in Mandibular Permanent Molars: A Randomized Controlled Clinical Trial
The study compares the anesthetic efficacy of warm versus conventional 2% lignocaine for inferior alveolar nerve block in mandibular molars, evaluating success rates and onset time.
Read the detailed description
The study will be conducted following approval from the Institutional Ethics Review Committee, AFID (ANX "A"). A total of 200 eligible patients visiting the Operative Dentistry Department at the Armed Forces Institute of Dentistry will be invited to participate. The procedure will be explained to the patients in Urdu, and written informed consent will be obtained (ANX "B").
Patients will be screened for eligibility through medical history, clinical examination, necessary tests, and peri-apical radiographs. Those meeting the inclusion criteria will be randomly assigned to one of two groups using a scientific random number table.
Group 1: Patients will receive conventional 2% lignocaine (at room temperature).
Group 2: Patients will receive pre-warmed 2% lignocaine (at 42°C). Root canal treatment will begin after the inferior alveolar nerve block (IANB) is administered. 1.8 mL of the local anesthetic will be delivered over 60 seconds using a 27-gauge needle. The first investigator will randomize participants by having them choose one of two differently colored balls to determine which anesthetic preparation (conventional or pre-warmed) they will receive. The conventional 2% lignocaine will be commercially available 2% lignocaine hydrochloride with 1:200,000 epinephrine, while the pre-warmed solution will be heated in a thermostatically controlled water bath or feeder bottle warmer (Philips AVENT) to 42°C.
The second investigator, who will be blinded to group allocation, will evaluate pain immediately after the block is administered by asking patients to rate their discomfort on a Visual Analog Scale (VAS). The onset of anesthesia will also be measured by performing gingival probing every 15 seconds. After rubber dam isolation, access cavity preparation will be performed, and pulp therapy will be initiated by the first investigator. The pulp therapy will be completed as needed, and the teeth will be restored with light-cured composite resin.
- Being tested
- conventional 2% lignocaine at room temperature, pre-warmed 2% lignocaine at 42°C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional 2% lignocaine at room temperatureDrug
This study aims to compare the effectiveness of warm 2% lignocaine (lidocaine) versus conventional room temperature 2% lignocaine for achieving successful inferior alveolar nerve blocks (IANB) in mandibular permanent molars
pre-warmed 2% lignocaine at 42°CDrug
This study aims to compare the effectiveness of warm 2% lignocaine (lidocaine) versus conventional room temperature 2% lignocaine for achieving successful inferior alveolar nerve blocks (IANB) in mandibular permanent molars
| Study group | Role | What they receive |
|---|---|---|
| conventional | Active comparator | Group 1: Patients receive conventional 2% lignocaine at room temperature. Receives: Drug: conventional 2% lignocaine at room temperature |
| warm (42 celsius) | Active comparator | Group 2: Patients receive pre-warmed 2% lignocaine at 42°C Receives: Drug: pre-warmed 2% lignocaine at 42°C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during administration of injection
Pain during administration of injection with 2% conventional and warm lignocaine on visual analogue scale is assessed. Visual Analog Scale, which is a tool used to measure a patient's perception of pain. It typically consists of a line, often 10 cm long, where one end represents "no pain" and the other end represents "worst possible pain." The patient marks a point on the line that corresponds to their level of pain. The distance from the "no pain" end to the point marked by the patient is then measured, usually in centimeters or millimeters, to quantify the pain intensity. Visual Analog Scale is commonly used in clinical trials to assess pain during and after procedures, as it provides a simple and reliable method for evaluating pain intensity.
Measured: 60 seconds
Onset of anesthesia in seconds
It will be measured by gingival probing every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application) It will be done by using both conventional and warm 2% lignocaine.
Measured: Every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start15 Dec 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Success of Inferior Alveolar Nerve BlockStudies 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
- 200 participants (estimated)
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 Ali Zafar, BDS, Principal investigator, AFID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806202
- Sponsor's protocol ID
- Lignocaine Efficacy in IANB
- Status last verified
- Jan 2025
- First submitted
- 15 Dec 2024
- Last updated
- 3 Feb 2025
- 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 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Anesthetic Efficacy of Warm and Conventional 2% Lignocaine for the Success of Inferior Alveolar Nerve Block (IANB) in Mandibular Permanent Molars: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06806202
- Acronym / sponsor ID
- Lignocaine Efficacy in IANB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 3 Feb 2025 (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.
The study compares the anesthetic efficacy of warm versus conventional 2% lignocaine for inferior alveolar nerve block in mandibular molars, evaluating success rates and onset time.
Detailed description
The study will be conducted following approval from the Institutional Ethics Review Committee, AFID (ANX "A"). A total of 200 eligible patients visiting the Operative Dentistry Department at the Armed Forces Institute of Dentistry will be invited to participate. The procedure will be explained to the patients in Urdu, and written informed consent will be obtained (ANX "B").
Patients will be screened for eligibility through medical history, clinical examination, necessary tests, and peri-apical radiographs. Those meeting the inclusion criteria will be randomly assigned to one of two groups using a scientific random number table.
Group 1: Patients will receive conventional 2% lignocaine (at room temperature).
Group 2: Patients will receive pre-warmed 2% lignocaine (at 42°C). Root canal treatment will begin after the inferior alveolar nerve block (IANB) is administered. 1.8 mL of the local anesthetic will be delivered over 60 seconds using a 27-gauge needle. The first investigator will randomize participants by having them choose one of two differently colored balls to determine which anesthetic preparation (conventional or pre-warmed) they will receive. The conventional 2% lignocaine will be commercially available 2% lignocaine hydrochloride with 1:200,000 epinephrine, while the pre-warmed solution will be heated in a thermostatically controlled water bath or feeder bottle warmer (Philips AVENT) to 42°C.
The second investigator, who will be blinded to group allocation, will evaluate pain immediately after the block is administered by asking patients to rate their discomfort on a Visual Analog Scale (VAS). The onset of anesthesia will also be measured by performing gingival probing every 15 seconds. After rubber dam isolation, access cavity preparation will be performed, and pulp therapy will be initiated by the first investigator. The pulp therapy will be completed as needed, and the teeth will be restored with light-cured composite resin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional | Active comparator | Drug: conventional 2% lignocaine at room temperatureGroup 1: Patients receive conventional 2% lignocaine at room temperature. |
| warm (42 celsius) | Active comparator | Drug: pre-warmed 2% lignocaine at 42°CGroup 2: Patients receive pre-warmed 2% lignocaine at 42°C |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
- Patient who have carious mandibular molars.
- Patients of either gender aged between 18-50 years old.
- Systemically healthy patients.
- Patients who agree to attend for recall appointments and provide a written consent
Key exclusion criteria (6 listed)
- Patients on preoperative analgesics and antibiotics.
- Teeth with calcified canals and previously treated teeth.
- Pregnant and lactating mothers.
- Patients who are immunocompromised, anxious and mentally handicapped.
- Patients who are allergic to lignocaine.
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 |
|---|---|---|
| conventional 2% lignocaine at room temperatureThis study aims to compare the effectiveness of warm 2% lignocaine (lidocaine) versus conventional room temperature 2% lignocaine for achieving successful inferior alveolar nerve blocks (IANB) in mandibular permanent molars | Drug | conventional |
| pre-warmed 2% lignocaine at 42°CThis study aims to compare the effectiveness of warm 2% lignocaine (lidocaine) versus conventional room temperature 2% lignocaine for achieving successful inferior alveolar nerve blocks (IANB) in mandibular permanent molars | Drug | warm (42 celsius) |
Primary outcome
Pain during administration of injection
Time frame: 60 seconds
Pain during administration of injection with 2% conventional and warm lignocaine on visual analogue scale is assessed. Visual Analog Scale, which is a tool used to measure a patient's perception of pain. It typically consists of a line, often 10 cm long, where one end represents "no pain" and the other end represents "worst possible pain." The patient marks a point on the line that corresponds to their level of pain. The distance from the "no pain" end to the point marked by the patient is then measured, usually in centimeters or millimeters, to quantify the pain intensity. Visual Analog Scale is commonly used in clinical trials to assess pain during and after procedures, as it provides a simple and reliable method for evaluating pain intensity.
Onset of anesthesia in seconds
Time frame: Every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application)
It will be measured by gingival probing every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application) It will be done by using both conventional and warm 2% lignocaine.
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 3 Feb 2025.
- 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.
Kanza Ali Zafar, BDS principal investigator
AFID
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing conventional 2% lignocaine at room temperature and pre-warmed 2% lignocaine at 42°C in people with Success of Inferior Alveolar Nerve Block and Inferior Alveolar Nerve Block, run by Armed Forces Institute of Dentistry, Pakistan at 1 site 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 5 inclusion and 6 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 3 Feb 2025. 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 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?
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 Maha Ali Mirza, BDS (00923337808809, mahaalimirza5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during administration of injection (time frame: 60 seconds). The study lists 2 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 3 Feb 2025.