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IRCT2015072123278N1 IRCT 2016-06-01 School of Dentistry, Tehran University of Medical Sciences The efficacy of articaine in mental injection Comparison of anesthetic efficacy of articaine as a primary injection between infiltration in the incisive/mental nerve region and inferior alveolar nerve block to treat mandibular premolar teeth with irreversible pulpitis: A, randomized, controlled, parallel, double blind study. 2015-08-31 anticipated 64 Complete https://irct.ir/trial/19880 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Permuted block randomization using sealed enveloped. 3 Local anesthesia. Intervention 1: Intervention group: IMNI: incisive/mental nerve infiltration Injection will be performed with 1.8 ml of articaine 4%with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) between the two mandibular premolars teeth, if the second premolar is missing the injection will be distal to the first premolar apex and if the first premolar was missing the injection will be at the apex of the second premolar. After the anesthesia has been confirmed with EPT, the regular root canal treatment will be initiated. If moderate or severe pain on the basis of the values of The Heft-Parker visual analogue scale (HP-VAS) is anticipated the patient will be injected with another cartridge of 4% articaine with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) by the inferior alveolar block technique. Intervention 2: Control group: Inferior alveolar nerve block (IANB). After isolation of the teeth with cotton rolls and drying them with gauze, fluoride gel or tooth paste will be applied to the probe tip of electric pulp tester and will be placed midway between the gingival margin and the occlusal edge of the tooth that is being tested (according to the manufacturer’s guidelines). Injection will be performed with 1.8 ml of 4% articaine with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) according to malamed technique. After the anesthesia has been confirmed with EPT, the regular root canal treatment will be initiated. If moderate or severe pain on the basis of the values of The Heft-Parker visual analogue scale (HP-VAS) is anticipated the patient will be injected with another cartridge of the same solution injection to the mental foramen region.
public Dr. Sholeh Ghabraei
Department of Endodontics, School of Dentistry, Kargar St, Enghelab Street
Tehran Iran (Islamic Republic of) +98 21 8835 1173 sholhghabraei@yahoo.com Tehran University of Medical Sciences scientific Dr. Sholeh Ghabraei
Department of Endodontics, School of Dentistry, Kargar St, Enghelab Street
Tehran Iran (Islamic Republic of) +98 21 8835 1173 sholhghabraei@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Healthy patients who seek treatment for mandibular premolar teeth diagnosed with irreversible pulpitis; patients who accept to sign the informed consent Exclusion criteria: Hematological and clotting disorders; neurological disorders; allergies to local; anesthetic drugs or sulfites; pregnancy at the time of the study; Younger than 18 year older than 65 year; patients with a history of significant medical conditions (American Society of Anesthesiologists class II or higher); clinically observed lesions or swellings at the injection site 18 years 65 years Both Y48.3 Local anaesthetics Treatment - Other Treatment - Other Intervention group: IMNI: incisive/mental nerve infiltration Injection will be performed with 1.8 ml of articaine 4%with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) between the two mandibular premolars teeth, if the second premolar is missing the injection will be distal to the first premolar apex and if the first premolar was missing the injection will be at the apex of the second premolar. After the anesthesia has been confirmed with EPT, the regular root canal treatment will be initiated. If moderate or severe pain on the basis of the values of The Heft-Parker visual analogue scale (HP-VAS) is anticipated the patient will be injected with another cartridge of 4% articaine with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) by the inferior alveolar block technique. Control group: Inferior alveolar nerve block (IANB). After isolation of the teeth with cotton rolls and drying them with gauze, fluoride gel or tooth paste will be applied to the probe tip of electric pulp tester and will be placed midway between the gingival margin and the occlusal edge of the tooth that is being tested (according to the manufacturer’s guidelines). Injection will be performed with 1.8 ml of 4% articaine with 1:100,000 epinephrine (Articadent; Dentsply Pharmaceutical, York, PA, USA) according to malamed technique. After the anesthesia has been confirmed with EPT, the regular root canal treatment will be initiated. If moderate or severe pain on the basis of the values of The Heft-Parker visual analogue scale (HP-VAS) is anticipated the patient will be injected with another cartridge of the same solution injection to the mental foramen region. Anesthesia. Timepoint: during the root canal treatment procedure. Method of measurement: by VAS(visual analogue scale) and EPT(electric pulp tester). The onst of the anesthesia. Timepoint: before starting the root canal treatment. Method of measurement: by EPT (electric pulp tester). The duration of anesthesia. Timepoint: time from the confirmation of anesthesia until the anesthesia subsided or the patient start to have pain again. Method of measurement: electric pulp tester and visual analogue scale. Pain. Timepoint: from injection through out the treatment and one week after the treatment. Method of measurement: visual analogue scale (VAS). School of Dentistry, Tehran University of Medical Sciences Approved 2016-02-08 Ethics committee of Tehran University of Medical Sciences Tehran, District 6, Pour Sina St Tehran Iran (Islamic Republic of)