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Search / Trial NCT03445182

Effectiveness of DentalVibe in Reducing Injection Pain and Anxiety During Local Anaesthesia in Children

Launched by PLOVDIV MEDICAL UNIVERSITY · Feb 20, 2018

Trial Information

Current as of April 25, 2025

Completed

Keywords

Pain Control Paediatric Dental Patients Local Anaesthesia Dentalvibe

ClinConnect Summary

Achieving local anaesthesia in children is one of the critical aspects of pain management.

In recent years, several innovative dental appliances have been developed on the concept to reduce the pain of needle injection by applying pressure, vibration, microoscillations or a combination of them.

Тhe aim of this study is to determine the effectiveness of DentalVibe (DV) in reducing injection pain and anxiety associated with local anaesthesia in paediatric patients.

The clinical trial is a randomized split-mouth assignment. Included patients are healthy positive children 8-12 years old requ...

Gender

ALL

Eligibility criteria

  • Exclusion criteria:
  • Children who are considered medically compromised or medically complex patients. The absence of disease is confirmed by anamnestic interview with a parent or a care-giver of the child and excludes general acute or chronic disease, cognitive impairment, psychogenic nonepileptic events.
  • Patients who are undergoing therapy with neurological, sedative, analgesic and/or anti-inflammatory drugs 7 days prior to treatment.
  • Patients with allergy to local anesthetics of the amide group.
  • Children, who are first time ever dental patients.
  • Inclusion criteria:
  • Patients, identified as positive or definitely positive through Frankl behavioral rating scale.
  • Children, requiring local anaesthesia infiltration for extraction of two primary upper jaw molars bilaterally.
  • Indications for extraction of primary molars: over-retention - in case of delayed physiological change and tendency of eruption of the permanent tooth; orthodontic reasons - tooth removed to prevent or correct malocclusion; advanced root resorption and imminent physiological tooth replacement; teeth with a severely damaged clinical crown (from trauma or caries and its complications); teeth with failed pulpotomy, acute or chronic diffuse periodontitis, endangering the germ of the permanent tooth.
  • Obtained informed consent from parents or gave-givers to participate in the study.

Trial Officials

Ani Beltcheva

Study Director

Medical University - Plovdiv, Bulgaria

About Plovdiv Medical University

Plovdiv Medical University is a distinguished academic institution dedicated to advancing medical education, research, and clinical practice. With a robust commitment to scientific innovation and public health, the university actively engages in clinical trials to enhance therapeutic interventions and patient outcomes. By fostering collaborations with healthcare professionals and researchers, Plovdiv Medical University aims to contribute significantly to the body of medical knowledge and improve healthcare delivery through rigorous clinical research. Its state-of-the-art facilities and comprehensive training programs ensure that the institution remains at the forefront of medical advancements in the region and beyond.

Locations

Plovdiv, , Bulgaria

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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