Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06333730 |
| Other study ID # |
PMC |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
June 20, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Prime Foundation |
| Contact |
Iftikhar Akbar, FCPS, CHIPE |
| Phone |
00923479368676 |
| Email |
driftikhar156[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
