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

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 in pediatric dental patients.

Study Overview

• Status: Unknown
• Conditions: Dental Anxiety
• Intervention / Treatment: Device: injection using DentalVibe comfort system; Device: traditional dental injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DV group; Device: injection using DentalVibe comfort system. giving maxillary infiltration dental local anesthesia with the aid of "DentalVibe comfort system" on one side of the maxillary arch prior extraction of primary molar tooth	Device: injection using DentalVibe comfort system; giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
Active Comparator: C group; Device: traditional dental injection giving maxillary infiltration dental local anesthesia without the aid of "DentalVibe comfort system" on the other side of the maxillary arch prior extraction of primary molar tooth	Device: traditional dental injection; giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain during injection	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.	within 1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Norhan El-dokky, PHD, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: January 22, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CEBC-CU-2017-01-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes