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Neuropeptide Y Regulates Neurogenic Pulp Inflammation

Neuropeptide Y Regulates Tooth Bleaching Agent-induced Neurogenic Pulp Inflammation: An In-Vivo Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06606236
Enrollment
40
Registered
2024-09-20
Start date
2024-02-05
Completion date
2024-02-28
Last updated
2024-09-23

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

Conditions

Dental Pulp Disease, Neurogenic Inflammation

Keywords

NPY, Dental Pulp, Dental Bleaching, Neurogenic Inflammation

Brief summary

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).

Interventions

OTHERH2O2 at 35% for 8 minutes

The investigators rigorously followed the manufacturer's instructions for all bleaching systems.

OTHERH2O2 at 40% for 20 minutes

The investigators rigorously followed the manufacturer's instructions for all bleaching systems.

OTHERH2O2 at 25% plus cold blue light for 15 minutes

The investigators rigorously followed the manufacturer's instructions for all bleaching systems.

Sponsors

Institucion Universitaria Colegios de Colombia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Masking description

The bleaching agent was applied using specific devices, with only the laboratory staff able to identify the corresponding group codes, which consisted of letters and numbers.

Intervention model description

Sample Collection: Teeth were anesthetized after tooth bleaching using 3% mepivacaine without a vasoconstrictor for maxillary premolars and an inferior alveolar nerve block for mandibular premolars. 10 minutes later, teeth were extracted within 5 minutes. For the control group, extractions also occurred ten minutes post-anesthesia. After extraction, teeth were rinsed with 5.25% sodium hypochlorite to eliminate any remaining periodontal ligament. Teeth were sectioned with a Zekrya bur, and pulp tissue was collected with a sterile excavator, placed in a 1 ml 4% paraformaldehyde Eppendorf tube, and stored at -70°C. ELISA: Fifty microliters of each standard, blank, and sample were added to wells in duplicate. A working solution with biotinylated antibody was added, and the plate was incubated at 37°C. After washing, horseradish peroxidase-conjugated solution was added, followed by substrate and stop solution. The optical density of each well was measured at 450 nm.

Eligibility

Sex/Gender
ALL
Age
18 Years to 27 Years
Healthy volunteers
Yes

Inclusion criteria

* Dental pulps were collected from non-smoking donors * Patients who need premolar extractions for orthodontic purposes. * These premolars must meet the following requirements: * Caries and restoration-free, * Complete root development (visually and radiographically confirmed), * Normal response to sensitivity testing.

Exclusion criteria

* Evidence of periodontal disease, * Traumatic occlusion * Previous orthodontic force application.

Design outcomes

Primary

MeasureTime frameDescription
Neuropeptide Y expression8-20 minutesMeasurement of the increase or not of NPY expression compared to the control group (teeth without intervention)

Countries

Colombia

Outcome results

None listed

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