Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars

Efficacy of Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars During Pulpotomy Procedure (Randomized Clinical Trial)

Background: Articaine hydrochloride has steadily grown in popularity, and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy. The most common technique to anesthetize mandibular primary teeth is in-ferior alveolar nerve block (IANB) which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable.

Aim: Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure.

Materials and Methods: The study will be two-arm randomized controlled clinical trial, parallel design and it will be setup and reported according the CONSORT guidelines. A total of 52 healthy children aged 5-6 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy. Written informed consent will be obtained from guardian. Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used.

Group I (Experimental group n =26) assigned to articaine infiltration anesthesia, while group II (Control group n = 26) assigned to the conventional IANB injection articaine.

Pain will be assessed by three diferent methods: physiological method using the Heart rate as vital parameter of pain, and will be recorded at base line, during injection, pulpotomy and stainless steel crown (SSC) preparation. Objective method using Sensory, Eye, Motor (SEM) scale, and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Other: Articaine infiltration technique; Other: Articaine nerve block technique

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Positive or definitely positive behavior during preoperative assessments according to the Frankl's behavior ratings III and IV.
• Patients whose mandibular second primary molars are indicated for pulpotomy according to the AAPD.
• Patients whose parents will give their consent to participate

Exclusion Criteria:

• Children with any systemic disease or special health care.
• History of allergy to local anesthesia.
• Radiographic evidence of periapical or inter-radicular radiolucency
• Patients with previous negative dental experience.
• Presence of soft tissue lesions at the site of injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: Articaine nerve block technique; this technique will be performed with articaine and epinephrine 1/100 000 for all patients on their second primary molar with conventional technique inferior alveolar nerve block. The thumb will be placed on the occlusal surface of intended side and protruded toward the inner oblique ridge of ramus and then placed in touch with retromolar pad. The syringe will be directed between the two mandibular primary molars of opposite side and the needle will be pushed forward until hitting the bone, then the injection will be slowly done. After three to five minutes, treatment will be started, after numbness in the lower lip is achieved
Experimental: Test group	Other: Articaine infiltration technique; infiltration will be performed with articaine and epinephrine 1/100 000 (Artinibsa, Inibsa, Barcelona, Spain) for all patients on their second pri-mary molar. The needle tip was placed in the buccal vestibule and then directed to the apex of the tooth and about one-third to one-fourth of the cartridge will be slowly discharged

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in heart rate	Heart rate (HR) is a physiological sign of pain.(30) It will be measured using a pulse oximeter.	During procedure
change in pain level	Sound, Eye, Motor (SEM) Scale(31) (Appendix III), will used as an ob-jective method for pain assessment during LA administration, pulpo-tomy and SSC. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial ob-server using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: com-fort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by sum-ming the three grades of the parameters.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adevrse events	The presence of any adverse events including infection, oral/tooth pain, patients will be seen after 24 hours to detect any lip/cheek biting and parasethia	After 24 hours

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2023
• Primary Completion (Actual): June 18, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 1, 2024
• First Submitted That Met QC Criteria: January 1, 2024
• First Posted (Estimated): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Carticaine
• Other Study ID Numbers: 0636_2/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No