Efficacy of Pressure Massage and Topical Gel on Pain During Intra Oral Injections
Condition: Normal Pulp/ Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Eighty patients with inclusion criteria will participate in this studyEach patient will
      receive an injection in one of the following groups according to the random number table:

        1. Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)

        2. Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB

        3. Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)

        4. Group TGI: Topical gel with a MAI. Immediately after the injection, patients will be
           asked to record the amount of pain they felt during needle penetration and injection
           using VAS form.Data will be analyzed using ANOVA and t-test.
    

Detailed description: 
      Eighty patients will be requested to take participate in this study after signing a written
      consent form. The inclusion criteria for the participants are as follows: 18-65 years old,
      having no systemic disease, not pregnant or beast feeding, having a mandibular premolar/molar
      or a maxillary anterior tooth with the diagnosis of normal pulp, reversible pulpitis or
      asymptomatic irreversible pulpitis (no or mild tenderness to percussion, normal periapical
      radiographic appearance), not taking analgesics, sedative or anti-anxiety medication and no
      intra oral injection at the treatment area, during the last 24 hours. By using a 170 mm
      Visual Analogue Scale (VAS), patients with pain less than or equal to 54 are classified as
      having asymptomatic irreversible pulpitis. The way to use the VAS will be explained to the
      patients prior to the procedure.

      Each patient will receive an injection in one of the following groups according to the random
      number table:

        1. Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)

        2. Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB

        3. Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)

        4. Group TGI: Topical gel with a MAI

      All the injections will be performed using an aspirating syringes containing 1.8 ml of
      lidocaine with 1:80000 epinephrine (2%Persocaine_E; Darupakhsh, Tehran, Iran) and 28-guage
      needles by a single operator (N.M.A). Immediately after the injection, patients will be asked
      to record the amount of pain they felt during needle penetration and injection using VAS
      form. If the patient is subjected to more than one injection during the root canal treatment,
      only the first injection will be subjected to the evaluation. Recording of the acquired data
      from the VAS forms will be done by another operator (P.M) who will be unaware of the
      patients' categorization.

      Data will be analyzed using ANOVA and t-test with the significance level of p<0.05.
    

Intervention name(s): 20% Benzocain (Master-Dent, Monroe, NC); Topical pressure massage
Intervention type(s): Drug; Other
Intervention description(s): Two topical anesthetic gel groups will receive anesthetic gel at the site of injection with massage on treating tooth.; Two topical pressure massage groups will receive topical placebo gel with pressure massage at the site of injection.
Other intervention name(s): Topical anesthetic gel
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anesthesia; injection; pain; pressure massage; topical gel