Comparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars

NCT07846098 | Active Not Recruiting

• 1 other identifier: CumhuriyetU_ArzuKockanat_003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to compare computerized intra-osseous injection system to the conventional inferior alveolar nerve block in primary mandibular teeth.

Conditions

Pain; Dental Caries

Keywords

intraosseous anesthesia; inferior alveolar nerve block; primary molar teeth

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Measured by Visual Analog Scale (VAS)

  Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst possible pain). Scores range from 0 to 10, with higher scores indicating greater pain.

  Immediately after anesthetic injection and during dental treatment (Day 1)

Secondary Outcomes (2)

• Heart Rate

  Immediately before injection (baseline), during injection, and immediately after injection (Day 1)

• Dental Anxiety and Behavior Measured by Venham Clinical Anxiety Rating Scale

  Immediately after anesthetic injection and during dental treatment (Day 1)

Study Arms (2)

inferior alveolar nerve block

ACTIVE COMPARATOR

Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe

Other: Inferior Alveolar Nerve Block

intraosseous anaesthesia

EXPERIMENTAL

Computerized intraosseous anesthesia administration using SleeperOne5

Other: intraosseous anaesthesia

Interventions

Inferior Alveolar Nerve Block OTHER

inferior alveolar nerve block using Articaine 4% with 1/200000 Adrenaline and a traditional needle injection

inferior alveolar nerve block

intraosseous anaesthesia OTHER

intraosseous anaesthesia using Articaine 4% with 1/200000 Adrenaline and a special intraosseous injection device

intraosseous anaesthesia

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 8 years
• Systemically healthy (American Society of Anesthesiologists \[ASA\] physical status I)
• Positive or definitely positive behavior (Frankl Behavior Rating Scale score 3 or 4)
• Bilateral (contralateral) mandibular primary molars with deep dentin caries requiring treatment
• Able to attend a second appointment
• Written informed consent from a parent/legal guardian and assent from the child

You may not qualify if:

• Known allergy to local anesthetic solutions
• Use of analgesics within the last 24 hours
• Acute infection
• Gingivitis, oral fistula, abscess, or bone loss in the area where anesthesia will be administered

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Dental Caries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Arzu Koçkanat, Asst.Prof.

  Cumhuriyet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: September 29, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)