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

Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block for Restorative Dental Treatment in Mandibular First Permanent Molars: A Randomized Clinical Tria

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06353815
Enrollment
44
Registered
2024-04-09
Start date
2024-07-31
Completion date
2025-06-30
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restorative Dental Treatment by Buccal Infiltration Anaesthesia

Keywords

buccal infiltration

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

Interventions

OTHER4% 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 .

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Success of local anesthesia10 minutesOperator will record the LA as Successful if the scheduled restorative treatment was completed with standard treatment management strategies after administration of the trial anaesthetic. If treatment could not be continued after 10 minutes from when the LA was first administered, and the full 1.8 ml cartridge of the trial anaesthetic had been used, then the LA was considered unsuccessful

Secondary

MeasureTime frameDescription
Child behavior during treatmentIntraoperativeDoaa Moustafa: he patient's behavior will be evaluated for pain perception during treatment using the SEM scale (Appendix 3: SEM scale ). The SEM scale is an objective pain \[10:04 pm, 31/3/2024\] Doaa Moustafa: assessment scale with scores ranging from 1 to 4, illustrating comfort to severe discomfort based on sounds, eye, motor parameters

Contacts

Primary ContactDoaa Moustafa, bachelor's degree
Doaa.moustafa@dentistry.cu.edu.eg01064174546

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026