Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Anesthetic Efficacy of 1.8 ml Versus 3.6 ml of 4% Articaine Buccal Infiltration

NCT06119139

Symptomatic Irreversible Pulpitis

NOT_YET_RECRUITING NA

Buccal Infiltration Technique Compared to Inferior Alveolar Technique

NCT04812639

Local Anesthetic Complication

UNKNOWN NA

Assessment of Needleless Jet Injection in Pain and Anxiety Management During Vital Pulpotomy of Primary Molars

NCT06001710

Anesthesia

COMPLETED NA

Clinical and Radiographic Outcomes of Rotary Instrumentation in Primary Molars

NCT07319741

Pulpectomy Irreversible Pulpitis

NOT_YET_RECRUITING NA

Intraosseus Injection Using Extra-short Needle Combined With Infiltration in Pediatric Patients With Molar Incisor Hypomineralization

NCT07239050

Molar Hypomineralization

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will be an eight-armed randomized controlled trial, parallel design. A total of 120 pediatric dental patients aged from 5 to 9 years with good health, will be selected from the Pediatric Dentistry and Dental Public Health Department clinic, Faculty of Dentistry, Alexandria University, Egypt. They will be recruited among those who need local anesthesia to perform either quadrant restorative treatment or extraction of their primary molars. Participants will be allocated into 2 groups according to the local anesthetic technique to be used. Children in the test group will receive intraosseous anesthesia using QuickSleeper5, while inferior alveolar nerve block or infiltration anesthesia will be used for those who are in the control group. All the procedures will be videotaped. Pain response upon needle prick and dental treatment will be assessed subjectively using the visual analogue scale, and objectively using Face, Leg, Activity, cry, Consolability scale. Physiological parameters will also be recorded to determine pain reaction. Efficacy, latency period and duration of anesthesia will be recorded for both injection techniques. Child behaviour toward dental treatment in both injection techniques will be evaluated using Frankl rating scale. Dental anxiety of pediatric patients will be evaluated from the videotapes using VENHAM Clinical Anxiety Scale. Postoperative assessment for the occurrence of any adverse events is planned.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irreversible Pulpitis Tooth Extraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

• Group IA

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.

Group Type EXPERIMENTAL

Quicksleeper5

Intervention Type DEVICE

intraosseous anesthesia for dental treatment

• Group IB

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

Group Type ACTIVE_COMPARATOR

conventional anesthesia

Intervention Type DEVICE

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

• Group IC

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.

Group Type EXPERIMENTAL

Quicksleeper5

Intervention Type DEVICE

intraosseous anesthesia for dental treatment

• Group ID

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

Group Type ACTIVE_COMPARATOR

conventional anesthesia

Intervention Type DEVICE

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

• Group IIA

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

Group Type EXPERIMENTAL

Quicksleeper5

Intervention Type DEVICE

intraosseous anesthesia for dental treatment

• Group IIB

15 maxillary primary molars indicated for extraction allocated to Infiltration anesthesia

Group Type ACTIVE_COMPARATOR

conventional anesthesia

Intervention Type DEVICE

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

• Group IIC

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

Group Type EXPERIMENTAL

Quicksleeper5

Intervention Type DEVICE

intraosseous anesthesia for dental treatment

• Group IID

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

Group Type ACTIVE_COMPARATOR

conventional anesthesia

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quicksleeper5

intraosseous anesthesia for dental treatment

Intervention Type DEVICE

conventional anesthesia

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes