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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Iftikhar Akbar, FCPS, CHIPE contact

00923479368676

driftikhar156@hotmail.com

Marghalara Noor, BDS contact

00923359631393

marghalaranoor96@gmail.com

Pakistan1 site, 1 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

    Recruiting

Other trials in Pakistan

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.

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 groups in NCT06333730
Study groupRoleWhat they receive
Inferior Alveolar Nerve Block (IANB)Experimental48 patients will be randomly selected in inferior alveolar nerve block group
Receives: Procedure: inferior alveolar nerve block
Mental Nerve Block (MNB)Experimental48 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.

  1. 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.

  1. First posted27 Mar 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion30 May 2024 (estimated)
  4. Study completion20 Jun 2024 (estimated)

Resources

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)
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

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.

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