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Assessing the Benefits of the Vibraject Attachment

Assessing Pain Behaviors of Children Receiving Local Anesthesia Using VibraJect Attachment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01227525
Acronym
Vibraject
Enrollment
90
Registered
2010-10-25
Start date
2008-08-31
Completion date
2009-06-30
Last updated
2017-08-22

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

Conditions

Pain

Brief summary

Behavioral and physiologic observations suggest that the injection of local anesthetic is among the most feared or anxiety producing procedures during dental intervention. Discomfort during the injection is currently reduced by pharmacologic or mechanical methods. No technique has proven to be effective for every patient. The VibraJect LLC (USA) was first introduced in 1995 and was developed under the hypothesis that a vibrating needle would stimulate large diameter nerve fibers and thereby close the gate to smaller nerves carrying the pain signal from the injection site. Studies on adult patients have been promising. The purpose of this study is to investigate the efficacy of the VibraJect dental syringe attachment in reducing injection discomfort and procedural anxiety in the pediatric dental population.

Detailed description

One hundred children will be recruited from the UNMC Pediatric Dentistry clinic. Eligible children will be selected from the 4-6 year group who are scheduled for routine dental restorative treatment and who have or have never received a dental injection. Each patient will randomly participate in either a control or experimental condition. The device will be attached for both conditions. During the control injection, the dentist will perform the dental injection as usual. During the experimental injection, the dentist will activate the attached device and perform the injection. Immediately following each injection, the patient will rate the pain on a visual analog scale and a trained observer will rate the child's behavior on a Frankl behavior scale. A videotape of the procedure will be reviewed by an independent dentist who will evaluate the child's response and any perceived disruptive behavior. This observer will be blind to whether the instrument is functioning.

Interventions

DEVICEVibraject

The VibraJect clips onto the barrel of a conventional and intraligamentary dental syringe (and some disposable syringes) and vibrates the needle at a high frequency while injections are administered.

Sponsors

Keith Allen, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

1. Attending the UNMC pediatric dentistry clinic for dental restorations requiring injection of local anesthetic for restorative procedures with or without use of inhalation anesthesia but without physical restraint 2. age 4 to 8

Exclusion criteria

1. No parent or legal guardian is present 2. Parent does not give consent 3. Non-English speaking participants will be excluded because PI is English speaking and this study needs behavior guidance of children that only the dentist can deliver and not an interpreter.

Design outcomes

Primary

MeasureTime frame
Observed disruptive behavior1 Year

Secondary

MeasureTime frame
Behavior ratings by dentist of cooperative behavior1 Year
subjective pain ratings on visual analogue scale1 Year

Outcome results

None listed

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