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Not yet recruitingNCT06353815Updated Apr 9, 2024

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

An interventional study of 4% articaine infiltration in Restorative Dental Treatment by Buccal Infiltration Anaesthesia, sponsored by Cairo University. Not yet recruiting. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Cairo University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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

02

Conditions studied

  • Restorative Dental Treatment by Buccal Infiltration Anaesthesia

Keywords

  • buccal infiltration
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Group I (Experimental group) 4% articaine infiltration

    Other: 4% articaine infiltration

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

    Other: 4% articaine infiltration

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 .

06

What researchers measure

Primary outcomes

  1. Success of local anesthesia

    Operator 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

    Time frame: 10 minutes

Secondary outcomes

  1. Child behavior during treatment

    Doaa 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

    Time frame: Intraoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06353815
Lead sponsor
Cairo University
Responsible party
Doaa Moustafa (Resident at Pediatric Dentistry Department, Cairo University) — Principal investigator
First posted
Apr 9, 2024
Start date
Jul 2024 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Apr 9, 2024

Study contacts

Doaa Moustafa, bachelor's degree
Contact
Doaa.moustafa@dentistry.cu.edu.eg
01064174546

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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