Effectiveness of the Intraligamentary Anesthesia and Inferior Alveolar Nerve Block on Pain During Dental Treatment
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Objective: To compare the effectiveness and complications of intraligamentary anesthesia
      (ILA) with conventional inferior alveolar nerve block (IANB) during injection and dental
      treatment of mandibular posterior teeth.

      Materials and Methods: In this randomized, prospective clinical trial, 72 patients (39 males,
      33 females) patients scheduled for dental treatment of mandibular posterior teeth, were
      randomly allocated to ILA group (n=35) received ILA injection or IANB group (n=37) received
      the conventional IANB. Our primary outcome was to assess pain during the injection as well as
      pain and stress (discomfort) during dental treatment, using the Numeric Rating Scale (NRS)
      from 0 to 10 (0 = no pain, 10= the worst pain imaginable). Whereas; recording 24 hours
      postoperative complications were our Secondary outcomes.
    

Detailed description: 
      MATERIALS AND METHODS This prospective randomized comparative clinical trial was conducted in
      the integrated clinical course in the dental school of the University of Greifswald, Germany
      after the approval of the local ethics committee of the medical faculty in Greifswald (No. BB
      174/18) in a period from December 2018 to June 2019. The sample size calculation using
      "G*power version 3.1" (Heinrich-Heine-University / Germany) was based on the following
      estimates: T-test for means (difference between two independent means), effect size 0.7, α
      error 0.05 and power (1-ß error) 0.9. It resulted in a samples size of 36 patients in each of
      the two groups (IANB & ILA).

      Inclusion and Exclusion Criteria The patients requiring regular dental in permanent
      mandibular posterior teeth under local anesthesia were recruited with an age range of 18 to
      50 years. Patients were not included if they had a clinical or radiographic sign of acute
      abscess, pus or peri-radicular pathology. Also patients with a systemic disease requiring
      special considerations during their dental treatment or patients with contra-indications for
      any of the components of the anesthetic solution (allergy to articaine, epinephrine, and
      sulfite) were excluded.

      Clinical Treatment and Outcome Computer-generated randomization technique was applied to
      allocate the participants to one of the both study groups (ILA vs. IANB). The intensity of
      pain as well as stress during the injection of the local anesthesia and during the dental
      procedure was assessed by using the Numeric Rating Scale (NRS 0-10). The anesthesia was
      performed by the clinical instructors of the course being dental practitioners (GDPs) or by
      dental students in the 4th and 5th academic year in the integrated clinical course in the
      dental school of the University of Greifswald and recorded as dentist or student. The
      distributions of different experience level of clinical instructors, dental students in 4th
      and 5th year were considered. For the inferior alveolar nerve block, the patient was placed
      comfortably in a supine position on the dental chair. The start of the anesthetic procedure
      was done without using topical anesthesia. The IANB injection was administered with cannulas
      of 38 mm in length and a gauge of 0.4 mm (Sopira Carpule, Heraeus Kulzer GmbH Hanau,
      Germany). The patients were anesthetized with Ultracain DS Forte 1:100.00 (Sanofi Aventis,
      Germany), the active ingredient being articaine in 1.7 ml ampules (1 ml equal to 40 mg
      articaine hydrochloride and 0.012 mg epinephrine hydrochloride, which is included as a
      vasoconstrictor). Once the bone was contacted, 1.5 ml of anesthetic solution was injected
      slowly. Subsequently the needle was detached for approximately 1 cm and an addition of
      0.3-0.5 ml of local anesthetic solution was injected to anesthetize the lingual nerve.

      For the intraligamentary anesthesia, three different syringe systems were used with
      randomized selection: Softjet syringe (Henke-Sass Wolf, Tuttlingen, Germany), Citojet syringe
      (Sopira, Heraeus Kulzer GmbH Hanau, Germany), Ultrajet syringe (Sanofi-Aventis, Frankfurt am
      Main, Germany). The patients were also placed in a supine position and the dentist
      administered the ILA injection without using topical anesthesia with cannulas of 12 mm in
      length and a gauge of 0.30 mm (Sopira Carpule, Heraeus Kulzer GmbH Hanau, Germany). Also,
      Ultracain DS Forte 1:100.000 (Sanofi Aventis, Germany) was used from 1.7 ml ampules. The
      needle was navigated through the gingival sulcus with the bevel towards the alveolar bone and
      away from the root surface, at an angle of 30°-40° to the long axis of the tooth and 2- 3 mm
      into the periodontal ligament space between root and alveolar bone. For each root, 0.2 ml of
      local anesthetic was injected over at least 20 seconds according to Endo et al. (2008) as
      well as Bender and Taubenheim (2014).
    

Intervention name(s): local anaesthetic techniques
Intervention type(s): Other
Intervention description(s): The patients were anesthetized with two different local anaesthetic techniques.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: local anesthetic; dentistry; pain; techniques