Who is sponsoring NCT03445182?

NCT03445182 is sponsored by Plovdiv Medical University.

What drugs are being tested in NCT03445182?

Interventions in NCT03445182: Local anaesthesia with conventional syringe, Local anaesthesia with conventional syringe + Dentalvibe.

What condition does NCT03445182 study?

NCT03445182 studies Pain Management, Local Anaesthesia.

Is NCT03445182 still recruiting?

NCT03445182 is currently completed. Last updated 4 June 2021.

Last reviewed 2021-06-04 · How we verify

NCT03445182

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 4 June 2021

What this trial tests

NA trial testing Local anaesthesia with conventional syringe in Pain Management in 41 participants. Completed in 10 September 2019.

Timeline

1 April 2018

Primary endpoint
10 June 2019

10 September 2019

Quick facts

Lead sponsor	Plovdiv Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	1 April 2018
Primary completion	10 June 2019
Estimated completion	10 September 2019
Sites	1 location across Bulgaria

Drugs / interventions tested

Local anaesthesia with conventional syringe
Local anaesthesia with conventional syringe + Dentalvibe

Conditions studied

Pain Management — all drugs for Pain Management →
Local Anaesthesia — all drugs for Local Anaesthesia →

Sponsor

Plovdiv Medical University

Who can join

Adults 8 to 12, any sex, with Pain Management or Local Anaesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The 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 8-12 years old requiring local anesthetic infiltration with conventional syringe (CS) for extraction of two primary maxillary molars bilaterally. Eligible patients undergo two single-visit treatments after CFSS-DS measurement before each, where as DV is allocated to either first or second local anaesthesia procedure. Primary outcome measure will be pain felt during injection, reported by patient on VAS. Secondary outcome measures: self-reported anxiety during injection on FIS; pain-related behavior according to FLACC scale; heart-rate dynamics; patient preference to local anaesthesia method - CS or CS+DV.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy of vibrotactile device DentalVibe in reducing injection pain and anxiety during local anaesthesia in paediatric dental patients: a study protocol for a randomised controlled clinical trial.
Veneva E, Cholakova R, Raycheva R, Belcheva A. · · 2019 · cited 4× · PMID 31270121 · DOI 10.1136/bmjopen-2019-029460

Verify or expand the search:

Other recruiting trials for Pain Management

Currently open trials in the same condition.

NCT07369024 — Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults · Phase 2 · recruiting
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NCT07454993 — The Effect of Music During Colonoscopy · NA · recruiting
NCT07442539 — The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Hemorrhoid Surgery · NA · recruiting

Other Plovdiv Medical University trials

Trials by the same sponsor.

NCT07208838 — Validation of DDIVAT Digital Optotypes for Distance Visual Acuity Testing Among the Bulgarian Population · enrolling by invitation
NCT06496906 — Clinical and Radiographic Comparison of Two Minimally Invasive Tooth Extraction Systems · NA · completed
NCT04903275 — Caries Inhibition With CO2-Laser During Orthodontic Treatment · NA · unknown
NCT07075354 — Healing Outcomes Following Hydraulic Condensation With a Bioactive Bioceramic Sealer in Root Canal Treatment · NA · completed
NCT04733196 — Clinical Effectiveness of 5 Different Mouthwashes in the Treatment of Generalised Gingivitis · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03445182 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Plovdiv Medical University
Last refreshed: 4 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03445182.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing