Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block

NCT ID: NCT06353815

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-06-30

Brief Summary

Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars

Conditions

Restorative Dental Treatment by Buccal Infiltration Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group I (Experimental group) 4% articaine infiltration

Group Type: EXPERIMENTAL

4% articaine infiltration

Intervention Type: OTHER

Two injections using short needle and dental syringe will be given , the first injection is 1.5 ml out of 1.8 ml of 4% articaine with 1:100,000 epinephrine (ARTINIBSA 4% 1:100,000) in the mucobuccal fold adjacent to the mandibular first Molar, the second injection is 0.3 ml in the lingual side for lingual soft and hard tissues .

Group II (Control group) 4% articaine inferior alveolar nerve block

Group Type: ACTIVE_COMPARATOR

4% articaine infiltration

Intervention Type: OTHER

Two injections using short needle and dental syringe will be given , the first injection is 1.5 ml out of 1.8 ml of 4% articaine with 1:100,000 epinephrine (ARTINIBSA 4% 1:100,000) in the mucobuccal fold adjacent to the mandibular first Molar, the second injection is 0.3 ml in the lingual side for lingual soft and hard tissues .

Interventions

4% articaine infiltration

Two injections using short needle and dental syringe will be given , the first injection is 1.5 ml out of 1.8 ml of 4% articaine with 1:100,000 epinephrine (ARTINIBSA 4% 1:100,000) in the mucobuccal fold adjacent to the mandibular first Molar, the second injection is 0.3 ml in the lingual side for lingual soft and hard tissues .

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinical Criteria:

• Children aged between 6 years and 9 years having:
• Mandibular first permanent molar with simple caries not involving pulp showing the following criteria: A. No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule. B. Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.

Radiographic criteria:

• No sign of radiolucency in periapical or furcation area.
• No widening of PDL space or loss of lamina dura continuity.
• No evidence of internal/external pathologic root resorption

Exclusion Criteria

• • Uncooperative children.

• Children with systemic disease.
• Lack of informed consent by the child patient's parent.
• Refusal of participation.
• Allergy from anesthetic agent.
• Acute infection

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Moustafa

Resident at Pediatric Dentistry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Doaa Moustafa, bachelor's degree

Role: CONTACT

Doaa.moustafa@dentistry.cu.edu.eg

01064174546

Other Identifiers

anaesthetic efficacy

Identifier Type: -

Identifier Source: org_study_id