Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients

NCT06245161 | Unknown DMC

• 1 other identifier: 0588-01/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of intra-osseous anesthesia using Quicksleepr5 in pain elimination during dental treatment in maxillary and mandibular primary molars, compared to conventional anesthesia.

Conditions

Irreversible Pulpitis; Tooth Extraction

Keywords

Intraosseous anesthesia; Computer-controlled injection; pain management; dental anesthesia; pediatric dentistry

Outcome Measures

Primary Outcomes (3)

• Assessment of Pain Reaction objectively

  Pain response will be assessed using Face, Legs, Activity, Cry Consolability (FLACC) scale

  1- Preoperatively phase (baseline) 2- During LA administration. 3-During dental treatment: Rubber dam placement and tooth preparation Or tooth extraction

• Assessment of Pain Reaction subjectively

  it will done by the child using Face version of Visual Analogue Scale.

  1-Post injection phase (1- minute). 2- Post treatment phase (10 minutes)

• Child dental anxiety

  It will be assessed using VENHAM Clinical Anxiety Scale

  1-Preoperative phase (baseline) 2- During local anesthesia administration 3-During dental treatment (restorative or extraction)

Secondary Outcomes (2)

• Local anesthesia effect

  30 minutes postoperatively

• Assessment of occurrence of adverse events

  follow up 24 hour postoperatively

Study Arms (8)

• Group IA

EXPERIMENTAL

15 maxillary quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to Intra-osseous Anesthesia by QuickSleeper5.

Device: Quicksleeper5

• Group IB

ACTIVE COMPARATOR

15 maxillary quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to infiltration anesthesia

Device: conventional anesthesia

• Group IC

EXPERIMENTAL

15 Mandibular quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to Intra-osseous Anesthesia by QuickSleeper5.

Device: Quicksleeper5

• Group ID

ACTIVE COMPARATOR

15 mandibular quadrants each have at least one primary molar indicated for restorative treatment or vital pulp therapy, allocated to inferior alveolar nerve block (IANB) anesthesia

Device: conventional anesthesia

• Group IIA

EXPERIMENTAL

15 maxillary primary molars indicated for extraction allocated to Intra-osseous Anesthesia by QuickSleeper5

Device: Quicksleeper5

• Group IIB

ACTIVE COMPARATOR

15 maxillary primary molars indicated for extraction allocated to Infiltration anesthesia

Device: conventional anesthesia

• Group IIC

EXPERIMENTAL

15 Mandibular primary molars indicated for extraction, allocated to Intra-osseous Anesthesia by QuickSleeper5

Device: Quicksleeper5

• Group IID

ACTIVE COMPARATOR

15 Mandibular primary molars indicated for extraction, allocated to inferior alveolar nerve block (IANB) anesthesia.

Device: conventional anesthesia

Interventions

Quicksleeper5 DEVICE

intraosseous anesthesia for dental treatment

• Group IA; • Group IC; • Group IIA; • Group IIC

conventional anesthesia DEVICE

inferior alveolar nerve block for treating mandibular molars infiltration anesthesia for treating maxillary molars

• Group IB; • Group ID; • Group IIB; • Group IID

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cooperative children during preoperative assessments.
• Patients selected in the restorative group: presenting with at least one primary molar indicated for restorative treatment or vital pulp therapy, after thorough clinical and radiographic examination.
• Patients selected in the extraction group: presenting with at least one primary molar indicated for extraction.

You may not qualify if:

• Any physical or mental disability, or psychological problems.
• Immunocompromised patients.
• Hypersensitivity to local anesthetic drugs used
• History of previous dental local anesthesia.
• Taking analgesics or other medications that would alter the child behavior or awareness of pain 12- hours pre-operative

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University- Faculty of Dentistry

Alexandria, Alexandroa, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• sara quritum

  Alexandria Univeristy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sara Quritum, PhD

CONTACT

+201020019396; sara.quritum@alexu.edu.eg

Nadia Wahba, Prof

CONTACT

drnadiawahba@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants are blinded to the group assignment, as their visual field is blocked during needle adminstration in both groups, and the Audible sounds of the QuickSleeper5 will be mimicked in the control group. The operator will not be blinded to the type of the anesthesia administered due to different devices to be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 120 children eligible for the study will be divided into: Group I (restorative group): includes 60 quadrants, each have at least one primary molar indicated for restorative treatment or vital pulp therapy. It will be subdivided into 4 subgroups, each consists of 15 quadrant (upper and lower) allocated to Intra-osseous Anesthesia by QuickSleeper5 for the test groups or to infiltration or IANB in the control group Group II (extraction group): includes 60 primary molars indicated for extraction. It will be subdivided into 4 subgroups; according either maxillary or mandibular primary molar is indicated for extraction, using Intra-osseous Anesthesia by QuickSleeper5 for the test groups ,or infiltration or IANB in the control group

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: February 7, 2024
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 7, 2024

Record last verified: 2023-10

Locations

EG (1)