Neuropeptide Y Regulates Neurogenic Pulp Inflammation

September 19, 2024 updated by: Javier Caviedes-Bucheli, Institucion Universitaria Colegios de Colombia

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
        • Facultad de Odontologia, Unicoc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The teeth were not exposed to dental bleaching agents (healthy pulps with normal/basal NPY values). n=10
Experimental: Pola Office system group
Application of Pola office n=10
Other: H2O2 at 35% for 8 minutes
The investigators rigorously followed the manufacturer's instructions for all bleaching systems.
Experimental: Opalescent Boost system group
Application of Opalescent Boost n=10
Other: H2O2 at 40% for 20 minutes
The investigators rigorously followed the manufacturer's instructions for all bleaching systems.
Experimental: Zoom system group
Application of Zoom! n=10
Other: H2O2 at 25% plus cold blue light for 15 minutes
The investigators rigorously followed the manufacturer's instructions for all bleaching systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropeptide Y expression
Time Frame: 8-20 minutes
Measurement of the increase or not of NPY expression compared to the control group (teeth without intervention)
8-20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institucion Universitaria Colegios de Colombia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

September 14, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neurogenic Inflammation

Clinical Trials on H2O2 at 35% for 8 minutes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe