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

• Register: ClinicalTrials.gov
• Last refreshed on: 14 June 2021
• Main ID: NCT03445182
• Date of registration: 20/02/2018
• Prospective Registration: Yes
• Primary sponsor: Plovdiv Medical University
• Public title: Effectiveness of DentalVibe in Reducing Injection Pain and Anxiety During Local Anaesthesia in Children
• Scientific title: Effectiveness of DentalVibe Comfort System in Reducing Injection Pain and Anxiety During Local Anaesthesia in Paediatric Patients
• Date of first enrolment: April 1, 2018
• Target sample size: 41
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03445182
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Bulgaria

Contacts

• Name: Ani Beltcheva
• Affiliation: Medical University - Plovdiv, Bulgaria

Key inclusion & exclusion 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.



Age minimum: 8 Years
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Local Anaesthesia

Pain Management

Intervention(s)

Procedure: Local anaesthesia with conventional syringe

Device: Local anaesthesia with conventional syringe + Dentalvibe

Primary Outcome(s)

Pain felt during injection using visual analogue scale [Time Frame: Immediately after local anaesthetic delivery]

Secondary Outcome(s)

Heart rate dynamics of the patient [Time Frame: Start: in the waiting room, at least 5 minutes before local anaesthesia procedure. End: at least 5 minutes after treatment.]

Self-reported anxiety during injection evaluated on FIS [Time Frame: Immediately after local anaesthetic delivery]

Pain-related behavior evaluated on the Faces, Legs, Activity, Cry, Consolability Behavioral Pain Rating Scale [Time Frame: During local anaesthesia procedure]

Assessment of self-reported dental fear on CFSS-DS questionnaire [Time Frame: Prior to each visit]

Patient preference to local anaesthesia method [Time Frame: One week after second procedure]

Secondary ID(s)

PlovdivMU1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors