How Successful is Supplemental Intraseptal Anaesthesia in Patients With Mandibular Teeth Extraction or Irreversible Pulpitis
Condition: Overcoming the Failure of Anesthesia in the Mandibular Teeth
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Introduction:

      Local anesthetic failure is an unavoidable aspect of dental practice. A number of factors
      contribute to this, which may be related to either the patient or the operator.
      Patient-dependent factors may be anatomical, pathological or psychological1-3. Work is still
      going on by dental clinicians and researchers in order to find an optimal local anesthetic
      agent which it has a high potency and rapid onset of action.4-6. However, pain free injection
      also play a role in improving the patient perceptions toward the dentist and dental
      treatments and encouraging patients to attend a regular checkup5-8.

      Failure of the local anaesthetic injections using Inferior Alveolar Nerve Block (IANB) for
      lower teeth in asymptomatic and symptomatic patients requires additional buck-up strategies
      to achieve pain free dental treatment. Otherwise, the patient complains of severe pain and
      hindering the clinician to proceed to the dental treatment.

      Mechanism of action for intraseptal injection The route of diffusion and distribution of the
      anaesthetic solution in the intraseptal technique is most likely through the medullary bone
      (Fig. 1). It offers anaesthesia to the bone, delicate/soft tissues, root structure in the
      region of infusion. It is best when both pain control and haemostasis are wanted for delicate
      /soft tissue and bony periodontal treatment.

      Figure 1: Represents the point of needle insertion for the Intraseptal Injection and the
      position of the needle 3mm apical to the apex of the papillary triangle5.

      Advantages of intraseptal injection In contrast to IANB and local infiltration, the
      intraseptal technique prevents the anaesthesia of tissues such as lips and tongue hence,
      decreases the chances of cheek or lip biting (self-trauma). It necessitates minimum or least
      dosage of local anaesthetic and minimizes bleeding during the surgical procedure. This
      technique being less traumatic, has immediate or instantaneous (<30-sec) onset of action and
      comparatively less number of postsurgical complications14. Intravascular injection is
      extremely unlikely to occur15compared to IANB or infiltration. Assertions that intraseptal
      anaesthesia is immediate are properly consistent with previous clinical results. Their
      findings reported that the onset of action for anaesthesia was within one minute after
      injection. So the onset time can be considered rapid if not immediate.

      Disadvantages of intraseptal Injection Clinical experience and multiple tissue punctures may
      be necessary to perform this technique. During the anaesthetic procedure, the anaesthetic
      solution may leak in to the oral cavity resulting discomfort and an unpleasant or bitter
      taste. The effective period anaesthesia for pulpal and soft-tissues is very limited20 hence
      multiple repeats may be required for longer surgical procedures.

      The aim of this prospective clinical study is to determine the anesthetic efficacy of the
      supplemental intraseptal technique in mandibular teeth diagnosed with extraction when the
      conventional inferior alveolar
    

Detailed description: 
      Methods:

      One hundred patients with mandibular teeth extraction will be recruited for this study.
      Following profound lip numbness after the administration of the conventional IAN block,
      dental extraction will be initiated. If patients experience moderate to severe pain during
      surgery either mesial and distal supplemental intraseptal injections using 0.8 mL 2%
      lidocaine with 1:000,000 epinephrine or buccal infiltration of 1.8 ml 4% articaine with
      1:000,000 epinephrine will be administered. Success will be defined as the ability to perform
      surgical extraction with mild to no pain.

      Patients recruited for this study will be adult patients of the College of Dentistry, The
      Taibah University, Almadinah Almunawwarah, who are deemed to be in good health as determined
      by a health history and oral questioning. All patients include in this study have to meet the
      following criteria: 18-65 years of age, in good health (American Society of Anesthesiologists
      classification I or II) and having one non-surgical tooth for extraction. Exclusion criteria
      were allergy to local anesthetics, history of significant medical problems (American Society
      of Anesthesiologists classification III or greater), having recently taken central nervous
      system depressants (including alcohol or any analgesic medications within 6 hours before
      treatment), pregnancy, lactating, or inability to give informed consent. The Taibah Dental
      College Human Subjects Review Committee will approve the study, and written informed consent
      will be obtained from each patient. After completion of the medical history and consent form,
      subjects completed the Modified Corah Dental Anxiety Scale Questionnaire.

      To qualify for the study, patient must have a mandibular tooth (molar, premolar or anterior),
      which need no surgical extraction either by sectioning or raising buccal flap along with bone
      removal. Therefore, each patient has a tooth that fulfilled the criteria for a clinical
      diagnosis of non-surgical extraction. After obtaining informed consent, patients will be
      given IAN block and dental extraction will be initiated once the profound lower lip numbness
      will be felt. During the extraction process, if the patient was complaining of pain the
      procedure will be stopped and the patient will be asked to rate his initial pain on a 170-mm
      Heft-Parker visual analog scale (VAS). The VAS was divided into 4 categories as described
      previously. The VAS scale consists of four categories. No pain corresponded to 0 mm. Mild
      pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the
      descriptors of faint, weak, and mild pain. Moderate pain was defined as greater than 54 mm
      and less than 114 mm. Severe pain was defined as greater than or equal to 114 mm. Severe pain
      included the descriptors of strong, intense, and maximum possible.

      Each patient will receive a conventional IAN block using 1 cartridge of 2% lidocaine with
      1:100,000 epinephrine ((Xylocaine; AstraZeneca LP, Dentsply, York, PA) using a conventional
      syringe (USA: ATI) and a 27-gauge, 30mm long needles (C-K Ject (27G) 0.4 x 30mm, Korea). The
      patient will be questioned every 2 minutes for 10 minutes or until lip numbness is apparent.
      Patients who do not achieve complete lip numbness within 10 minutes will disqualiﬁed from
      participation in the study, but dental extraction will be still performed after achieving
      profound anesthesia or giving additional local anesthesia.

      After lip numbness, a separate buccal nerve block will be administered for the molars using a
      standard syringe and 0.9 mL 2% lidocaine with 1: 100,000 epinephrine.

      During the extraction procedure, if the patient feel pain, the treatment will be stopped
      immediately, and the patient will rate his discomfort using the Heft-Parker VAS. If the pain
      rating is mild, extraction will continue. If the pain rating is moderate or greater (55mm or
      higher on the VAS), supplemental anesthesia will be administered.

      The success of the IAN block will be deﬁned as the ability to carry on the tooth extraction
      with no or mild pain (VAS score of 0 or ≤ 54 mm, respectively). All patients experiencing
      moderate to severe pain upon using elevators or forceps will receive either 2% lidocaine
      supplemental intraseptal injections or 4% articaine buccal infiltration.

      Intraseptal injections will be administered into the mesial and distal aspect of the involved
      tooth using 0.8 mL 2% lidocaine with 1: 100,000 epinephrine. A 27 gauge, 21mm short needle
      (C-K Ject (27G) 0.4 x 21mm, Korea) will be inserted into the target region which is located
      2-3mm apical to the apex of the papillary triangle (Figure. 1)5. The needle is introduced
      into the soft tissue and advanced until contact with bone is made. Pressure must be applied
      to the syringe and drive the barb slightly deeper (1 to 2 mm) into the interdental septum5.
      Afterward, anaesthetic solution (0.4 ml) is deposited in a minimum of 20 seconds time.

      Buccal infiltrations of 4% articaine (Septanest SP. Articaine hydrochloride 4% with 1:00.000
      epinephrine - Septodont, France) will be administered in the muccobuccal fold of the
      mandibular teeth which will be extracted over 60 sec. After completion of the intraseptal
      injection or buccal infiltration, the dental extraction will be resumed if the patient
      reports no or mild pain. The patient level of pain will be assessed every 2 minutes up to 10
      minutes. After 10 minutes if the patient still feels moderate to severe pain, treatment will
      again be stopped, and the extraction will be considered as a failure.

      Injection discomfort The discomfort of the injections will be recorded by the patients
      following IAN block and intraseptal injections on standard 100mm visual analogue scales
      (VAS), tagged at the endpoints with "no pain" (0 mm) and "unbearable pain" (100 mm).

      Power calculation A study with 73 patients was reported to have 84% power to detect a
      difference in anesthetic success rate of 30% (Webster et al, 2016) in a continuous outcome
      measure assuming a significance level of 5% and a correlation of 0.5 between responses from
      the same subject. So, a sample size of 100 patients would enable detection of a conﬁdence
      interval half width of 0.09 with a certainty of 90%.
    

Intervention name(s): 2% lidocaine with 1:000,000 epinephrine; 4% articaine with 1:000,000 epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): 2% lidocaine with 1:000,000 epinephrine is dental local anesthesia; 4% articaine with 1:000,000 epinephrine is dental local anesthesia
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Carticaine; Epinephryl borate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment