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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03033628
• Other study ID #: CEBC-CU-2017-01-06
• Status: Not yet recruiting
• Phase: N/A
• First received: January 22, 2017
• Last updated: February 14, 2017
• Start date: April 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: February 2017
• Source: Cairo University
• Contact: Muaaz Hilal, DR
• Phone: 00201226090374
• Email: muaaz09[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: January 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Anxiety

Intervention

Device:
• injection using DentalVibe comfort system
giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
• traditional dental injection
giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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