Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars

NCT ID: NCT06201949

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-16
• Study Completion Date: 2023-06-30

Brief Summary

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

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Test group

Group Type: EXPERIMENTAL

Articaine infiltration technique

Intervention Type: OTHER

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

Control group

Group Type: ACTIVE_COMPARATOR

Articaine nerve block technique

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Alexandria Faculty of Dentistry

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0636_2/2023

Identifier Type: -

Identifier Source: org_study_id