NCT06606236

Neuropeptide Y Regulates Neurogenic Pulp Inflammation

Completed NA Last updated 23 September 2024

What this trial tests

NA trial testing H2O2 at 35% for 8 minutes in Neurogenic Inflammation in 40 participants. Completed in 28 February 2024.

Timeline

5 February 2024

Primary endpoint
28 February 2024

28 February 2024

Quick facts

Lead sponsor	Institucion Universitaria Colegios de Colombia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	40
Start date	5 February 2024
Primary completion	28 February 2024
Estimated completion	28 February 2024
Sites	1 location across Colombia

Drugs / interventions tested

• H2O2 at 35% for 8 minutes
• H2O2 at 40% for 20 minutes
• H2O2 at 25% plus cold blue light for 15 minutes

Conditions studied

• Neurogenic Inflammation — all drugs for Neurogenic Inflammation →
• Dental Pulp Disease — all drugs for Dental Pulp Disease →

Sponsor

Institucion Universitaria Colegios de Colombia — full company profile →

Who can join

Adults 18 to 27, any sex, with Neurogenic Inflammation or Dental Pulp Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective. This study assessed the neuropeptide Y (NPY) expression in healthy human dental pulp following tooth bleaching with three in-office hydrogen peroxide-based systems: Opalescence Boost© (Ultradent Products, South Jordan, UT), Pola Office© (SDI, Victoria, Australia), and Zoom© (Zoom! Bleaching System; Discuss Dental, Culver City, CA).

Materials and Methods. Forty dental pulps were collected from healthy premolars scheduled for extraction for orthodontic reasons. Teeth were divided into four groups containing ten healthy premolars each: Control group (n= 10): the teeth were not exposed to dental bleaching agents (healthy pulps assessed for normal/basal NPY values). Pola Office system group (n= 10): application of Pola office (35% H2O2) for 8 minutes. Opalescent Boost system group (n= 10): application of Opalescent Boost (40% H2O2) for 20 minutes. Zoom system group (n= 10): application of Zoom! (25% H2O2 + cold blue light) for 15 minutes. The investigators rigorously followed the manufacturer's instructions for all bleaching systems. Following the extractions, the pulpal tissue was collected, placed in a 4% formaldehyde solution in Eppendorf tubes, and processed. NPY levels were measured using enzyme-linked immunosorbent assay (ELISA).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neuropeptide Y regulation of dental pulp neurogenic inflammation provoked by tooth bleaching agents: a descriptive comparative clinical study.
   Caviedes-Bucheli J, Ríos-Osorio N, Pérez-Villota M, Aucú-Miño K, et al · · 2026 · PMID 41680589 · DOI 10.5395/rde.2026.51.e10
2. Neuropeptide Y regulation of dental pulp neurogenic inflammation provoked by tooth bleaching agents
   Caviedes-Bucheli J, Pérez-Villota M, Aucú-Miño K, Escobar-Mafla D, et al · · 2024 · DOI 10.21203/rs.3.rs-5375900/v1