Clinical trial NCT06606236: Neuropeptide Y Regulates Neurogenic Pulp Inflammation
Official title: Neuropeptide Y Regulates Tooth Bleaching Agent-induced Neurogenic Pulp Inflammation: An In-Vivo Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Inflammation
Dental Pulp Disease
Keywords: NPY
Dental Pulp
Dental Bleaching
Neurogenic Inflammation
Lead sponsor: Institucion Universitaria Colegios de Colombia
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Neuropeptide Y expression
timeFrame: 8-20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Facultad de Odontologia, Unicoc
Study officials:
References:
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