Symptomatic Irreversible PulpitisNCT06333730
Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis
A study testing inferior alveolar nerve block and mental nerve block in people with Symptomatic Irreversible Pulpitis, run by Prime Foundation at 1 site in Pakistan.
Trial summary
Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- inferior alveolar nerve block and mental nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 20 Jun 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with mandibular premolars or lower anterior
- Experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester
- Bleeding during access opening
Who cannot join
- Participants with a medical history
- Allergies or contraindications to the local anesthetic
- Pregnant or breastfeeding women
- Patient taking pain-affecting medication
- Patient experiencing pain in more than one tooth
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Peshawar Dental College
Peshawar, Khyber Pakhtunkhwa, 25000
Prof. Dr. Iftikhar Akbar, FCPS, CHIPE, 00923479368676, driftikhar156@hotmail.com
Marghalara Noor, BDS, 00923359631393, marghalaranoor96@gmail.com
About this study
Official title: Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis- A Randomized Clinical Trial
Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth.
Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB.
Read more
Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included.
Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded.
Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison.
Read the detailed description
Symptomatic irreversible pulpitis is a dental condition characterized by inflammation of the dental pulp, a soft tissue containing nerves and blood vessels located within the tooth's central cavity. The inflammation is severe and incapacitates the pulp's ability to heal naturally, leading to its eventual necrosis, hence the label "irreversible." The clinical manifestation of symptomatic irreversible pulpitis is excruciating, unrelenting pain, aggravated by exposure to hot or cold stimuli, and pressure. Inadequate intervention exposes the patient to the risk of infection or abscess formation, necessitating extensive dental procedures, including root canal therapy or tooth extraction.
The inferior alveolar nerve block (IANB) is a widely employed regional anesthesia technique in dentistry, utilized to provide profound anesthesia of the mandibular teeth and gingivae. It is a safe and reliable anesthesia technique commonly used in dentistry to prevent pain during procedures such as extractions, root canals, and implant placement, ensuring a comfortable experience for the patient. The mental or incisive nerve block is a dental anesthesia technique that anesthetizes the lower teeth, gums, lower lip, and chin by blocking the incisive and mental nerves, which are branches of the inferior alveolar nerve.
Local anesthesia in endodontics provides pain relief and patient comfort during procedures such as root canal therapy by blocking nerve impulses that transmit pain signals to the brain. Painful pulpitis may require pulpectomy under local anesthesia, but the effectiveness of injections can vary between teeth, with mandibular teeth being less responsive compared to maxillary teeth due to their thicker cortical bone and more complex anatomy. The inferior alveolar nerve is typically blocked in the lower molar and premolar region to achieve numbness. However, this approach may not always provide complete numbing of the nerve endings in the teeth. To enhance the likelihood of success, it is recommended to administer supplemental injections such as intra-osseous injections or applying 4% articaine through the cheek along with the inferior alveolar nerve block.
In a randomized clinical trial with 153 participants, the anesthetic success rates for mental nerve block and IANB were 53% and 47%, respectively, with no significant difference between them. However, combining both techniques by adding an IANB to MINB significantly improved the success rates to 82%. In a study conducted by Batista da Silva and colleagues, the effectiveness of 0.6 mL of 2% lidocaine and 4% articaine administered outside the mental foramen was evaluated. The results showed that using 4% articaine resulted in a 70% to 80% success rate for anesthesia.
This randomized clinical trial will be conducted at department of operative dentistry, Peshawar dental college, Peshawar. Ethical approval will be obtained from the hospital's ethical board. The sample size will be 96(48 in each group) at 5% level of significance, 80% power of test, using success for IANB to be 53% and to be mental block 80%. To participate in this study, patients needed to have exposed caries in their mandibular premolars or lower anterior causing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening. They also needed to have a medical history falling under American Society of Anesthesiologists class I or II and understand pain scales. Patients with allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those with a history of drug abuse, taking pain-affecting medication, or experiencing active pain in more than one tooth will be excluded.
The participants will be randomly divided into two, one receiving mental nerve block (MINB) and other IANB using block randomization technique. Each block size was eight. After obtaining informed consent, eligible patients will be randomly assigned to receive either mental nerve block or inferior alveolar nerve block. To perform an inferior alveolar block with 2% lidocaine and adrenaline 1:80,000, the dental practitioner will first explain the procedure to the patient and obtained their informed consent. The patient will be positioned comfortably in a dental chair and with their head supported. The injection site will be sterilized with an antiseptic solution, and the syringe will be loaded with the anesthetic solution. Next, the dental practitioner will inserted the needle into the mucobuccal fold adjacent to the mandibular molars and advanced it towards the mandibular foramen, aiming slightly anteriorly and superiorly. Aspirating to check for blood or resistance, the needle will be repositioned if either was present. Once the needle is correctly positioned, the dental practitioner slowly inject 1.8-1.9 mL of the anesthetic solution while checking for any signs of nerve stimulation, such as lip or tongue numbness. After completing the injection, the needle will be withdrawn and disposed of properly in a sharps container. For the mental block with 2% lidocaine and adrenaline 1:80,000, the mental foramen will be located, and the needle is inserted. After aspiration, 0.6-0.9 mL of anesthetic was injected while monitoring for nerve stimulation. The needle will then withdrawn and disposed of properly. After three minutes the anesthetic efficacy of each technique will be evaluated by assessing the pain score during access opening and instrumentation using a visual analog scale (10 point scale). Score more than 3 was considered ineffective.
The data analysis will be performed using SPSS version 22. Descriptive statistics will be calculated for all numeric and categorical data. The efficacy of two interventions (IANB and MINB) will be compared using the chi-square test. Stratification will be performed based on gender to control confounders. A significance level of P < 0.05 will be considered significance.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- inferior alveolar nerve block, mental nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inferior alveolar nerve blockProcedure or surgery
After informed consent, the needle will be inserted into the muco-buccal fold adjacent to the mandibular molars and advanced it towards the mandibular foramen, aiming slightly anteriorly and superiorly. Aspirating to check for blood or resistance, the needle will be repositioned if either was present. Once the needle will be correctly positioned, the dental practitioner will slowly inject 1.8-1.9 mL of the anesthetic solution.
mental nerve blockProcedure or surgery
After informed consent, the needle will be inserted into the buccal fold between the lower premolars. Aspirating to check for blood or resistance. Once needle is correctly positioned, 0.6-0.9 ml of the anesthetic solution will be deposited.
| Study group | Role | What they receive |
|---|---|---|
| Inferior Alveolar Nerve Block (IANB) | Experimental | 48 patients will be randomly selected in inferior alveolar nerve block group Receives: Procedure: inferior alveolar nerve block |
| Mental Nerve Block (MNB) | Experimental | 48 patients will be randomly selected in mental nerve block group Receives: Procedure: mental nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS
Pain after anesthesia in both groups will be assessed through Visual Pain analogue scale and greater than 3 will be considered ineffective
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prime Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iftikhar Akbar, Prime Foundation
- Investigators
- Saifa Rashad, BDS, Study chair, Peshawar Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333730
- Sponsor's protocol ID
- PMC
- Status last verified
- Mar 2024
- First submitted
- 31 Oct 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis- A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06333730
- Acronym / sponsor ID
- PMC
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Prime FoundationUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 27 Mar 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.
Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth.
Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB.
Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included.
Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded.
Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison.
Detailed description
Symptomatic irreversible pulpitis is a dental condition characterized by inflammation of the dental pulp, a soft tissue containing nerves and blood vessels located within the tooth's central cavity. The inflammation is severe and incapacitates the pulp's ability to heal naturally, leading to its eventual necrosis, hence the label "irreversible." The clinical manifestation of symptomatic irreversible pulpitis is excruciating, unrelenting pain, aggravated by exposure to hot or cold stimuli, and pressure. Inadequate intervention exposes the patient to the risk of infection or abscess formation, necessitating extensive dental procedures, including root canal therapy or tooth extraction.
The inferior alveolar nerve block (IANB) is a widely employed regional anesthesia technique in dentistry, utilized to provide profound anesthesia of the mandibular teeth and gingivae. It is a safe and reliable anesthesia technique commonly used in dentistry to prevent pain during procedures such as extractions, root canals, and implant placement, ensuring a comfortable experience for the patient. The mental or incisive nerve block is a dental anesthesia technique that anesthetizes the lower teeth, gums, lower lip, and chin by blocking the incisive and mental nerves, which are branches of the inferior alveolar nerve.
Local anesthesia in endodontics provides pain relief and patient comfort during procedures such as root canal therapy by blocking nerve impulses that transmit pain signals to the brain. Painful pulpitis may require pulpectomy under local anesthesia, but the effectiveness of injections can vary between teeth, with mandibular teeth being less responsive compared to maxillary teeth due to their thicker cortical bone and more complex anatomy. The inferior alveolar nerve is typically blocked in the lower molar and premolar region to achieve numbness. However, this approach may not always provide complete numbing of the nerve endings in the teeth. To enhance the likelihood of success, it is recommended to administer supplemental injections such as intra-osseous injections or applying 4% articaine through the cheek along with the inferior alveolar nerve block.
In a randomized clinical trial with 153 participants, the anesthetic success rates for mental nerve block and IANB were 53% and 47%, respectively, with no significant difference between them. However, combining both techniques by adding an IANB to MINB significantly improved the success rates to 82%. In a study conducted by Batista da Silva and colleagues, the effectiveness of 0.6 mL of 2% lidocaine and 4% articaine administered outside the mental foramen was evaluated. The results showed that using 4% articaine resulted in a 70% to 80% success rate for anesthesia.
This randomized clinical trial will be conducted at department of operative dentistry, Peshawar dental college, Peshawar. Ethical approval will be obtained from the hospital's ethical board. The sample size will be 96(48 in each group) at 5% level of significance, 80% power of test, using success for IANB to be 53% and to be mental block 80%. To participate in this study, patients needed to have exposed caries in their mandibular premolars or lower anterior causing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening. They also needed to have a medical history falling under American Society of Anesthesiologists class I or II and understand pain scales. Patients with allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those with a history of drug abuse, taking pain-affecting medication, or experiencing active pain in more than one tooth will be excluded.
The participants will be randomly divided into two, one receiving mental nerve block (MINB) and other IANB using block randomization technique. Each block size was eight. After obtaining informed consent, eligible patients will be randomly assigned to receive either mental nerve block or inferior alveolar nerve block. To perform an inferior alveolar block with 2% lidocaine and adrenaline 1:80,000, the dental practitioner will first explain the procedure to the patient and obtained their informed consent. The patient will be positioned comfortably in a dental chair and with their head supported. The injection site will be sterilized with an antiseptic solution, and the syringe will be loaded with the anesthetic solution. Next, the dental practitioner will inserted the needle into the mucobuccal fold adjacent to the mandibular molars and advanced it towards the mandibular foramen, aiming slightly anteriorly and superiorly. Aspirating to check for blood or resistance, the needle will be repositioned if either was present. Once the needle is correctly positioned, the dental practitioner slowly inject 1.8-1.9 mL of the anesthetic solution while checking for any signs of nerve stimulation, such as lip or tongue numbness. After completing the injection, the needle will be withdrawn and disposed of properly in a sharps container. For the mental block with 2% lidocaine and adrenaline 1:80,000, the mental foramen will be located, and the needle is inserted. After aspiration, 0.6-0.9 mL of anesthetic was injected while monitoring for nerve stimulation. The needle will then withdrawn and disposed of properly. After three minutes the anesthetic efficacy of each technique will be evaluated by assessing the pain score during access opening and instrumentation using a visual analog scale (10 point scale). Score more than 3 was considered ineffective.
The data analysis will be performed using SPSS version 22. Descriptive statistics will be calculated for all numeric and categorical data. The efficacy of two interventions (IANB and MINB) will be compared using the chi-square test. Stratification will be performed based on gender to control confounders. A significance level of P < 0.05 will be considered significance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inferior Alveolar Nerve Block (IANB) | Experimental | Procedure: inferior alveolar nerve block48 patients will be randomly selected in inferior alveolar nerve block group |
| Mental Nerve Block (MNB) | Experimental | Procedure: mental nerve block48 patients will be randomly selected in mental nerve block group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants with mandibular premolars or lower anterior
- Experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester
- Bleeding during access opening
Key exclusion criteria (5 listed)
- Participants with a medical history
- Allergies or contraindications to the local anesthetic
- Pregnant or breastfeeding women
- Patient taking pain-affecting medication
- Patient experiencing pain in more than one tooth
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 |
|---|---|---|
| inferior alveolar nerve blockAfter informed consent, the needle will be inserted into the muco-buccal fold adjacent to the mandibular molars and advanced it towards the mandibular foramen, aiming slightly anteriorly and superiorly. Aspirating to check for blood or resistance, the needle will be repositioned if either was present. Once the needle will be correctly positioned, the dental practitioner will slowly inject 1.8-1.9 mL of the anesthetic solution. | Procedure or surgery | Inferior Alveolar Nerve Block (IANB) |
| mental nerve blockAfter informed consent, the needle will be inserted into the buccal fold between the lower premolars. Aspirating to check for blood or resistance. Once needle is correctly positioned, 0.6-0.9 ml of the anesthetic solution will be deposited. | Procedure or surgery | Mental Nerve Block (MNB) |
Primary outcome
COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS
Time frame: Two months
Pain after anesthesia in both groups will be assessed through Visual Pain analogue scale and greater than 3 will be considered ineffective
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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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.
Saifa Rashad, BDS study chair
Peshawar Dental 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 inferior alveolar nerve block and mental nerve block in people with Symptomatic Irreversible Pulpitis, run by Prime Foundation 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iftikhar Akbar, FCPS, CHIPE (00923479368676, driftikhar156@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS (time frame: Two months). 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 27 Mar 2024.