Pain Perception of Dental Local Anesthesia Using DentalVibe Comfort System in a Group of Egyptian Children

Pain Perception of Maxillary Infiltration Injection of Dental Local Anesthesia Using DentalVibe Comfort System Compared to Maxillary Infiltration Injection Alone in a Group of Egyptian Children: A Randomized Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03033628

Enrollment

Registered

2017-01-27

Start date

2017-04-01

Completion date

2018-01-01

Last updated

2017-02-15

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

Conditions

Dental Anxiety

Brief summary

Detailed description

The aim of this study is to compare pain during maxillary infiltration local anesthesia injection with the aid of DentalVibe comfort system in comparison to maxillary infiltration injection alone. Intervention: History taking from the child and the parent including personal, medical and dental history as in the examination sheet (Appendix A) to assess inclusion criteria. Clinical procedure: Intervention group: Clinical examination using mirror and probe to assess inclusion criteria. Before initiating the treatment, the site of the injection will be dried then prepped with antiseptic solution swab, then a topical anaesthetic agent (topical anesthetics 20% benzocaine) will be applied with a cotton tip applicator for 60 sec. Demonstration will be performed by putting the device into direct contact with the children's nails before applying the device intraorally. The cheek will be retracted and the device will be turned on. 1mL of local anesthetic solution (articaine hypochloride 4% with 1:100.000 epinephrine, Septodont) will be injected using a 27 gauge needle which will be delivered over 1 min. Control group: AS that of the intervention group except, the device will be used only as a cheek retractor during the injection, but will be turned off. Assessment: Objective assessment will be performed by observing the patients behavior using the FLAAC scale during the anesthetic injection and needle insertion. Subjective evaluation will be obtained using the Wong-Baker FACES pain rating scale.

Interventions

DEVICEinjection using DentalVibe comfort system

giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.

DEVICEtraditional dental injection

giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 7 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy children aged 6-7 years old. 2. Apparently healthy Children. 3. Cooperative children. 4. Children with carious maxillary bilateral primary molars indicated for extraction.

Exclusion criteria

1. Children who are allergic to amide group. 2. Children with Neurologic disorders. 3. Children with mental disability. 4. Presence of periapical or gingival legion. 5. Severe Gingivitis.

Design outcomes

Primary

Measure	Time frame	Description
pain during injection	within 1 year	pain assessment using FLACC behavioral pain assessment (scale 0-10) and Wong-Baker FACES pain rating scale (scale 0-10) e 0: Relaxed and comfortable 1-3: Mild discomfort. 4-6: Moderate pain. 7-10: Severe discomfort or pain or both.

Contacts

Primary ContactMuaaz Hilal, DR

muaaz09@hotmail.com00201226090374

Outcome results

None listed

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