Neuropeptide Y Regulates Neurogenic Pulp Inflammation

NCT ID: NCT06606236

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2024-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Neurogenic Inflammation Dental Pulp Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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Control group

The teeth were not exposed to dental bleaching agents (healthy pulps with normal/basal NPY values). n=10

Group Type NO_INTERVENTION

No interventions assigned to this group

Pola Office system group

Application of Pola office n=10

Group Type EXPERIMENTAL

H2O2 at 35% for 8 minutes

Intervention Type OTHER

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

Opalescent Boost system group

Application of Opalescent Boost n=10

Group Type EXPERIMENTAL

H2O2 at 40% for 20 minutes

Intervention Type OTHER

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

Zoom system group

Application of Zoom! n=10

Group Type EXPERIMENTAL

H2O2 at 25% plus cold blue light for 15 minutes

Intervention Type OTHER

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

Interventions

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H2O2 at 35% for 8 minutes

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

Intervention Type OTHER

H2O2 at 40% for 20 minutes

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

Intervention Type OTHER

H2O2 at 25% plus cold blue light for 15 minutes

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institucion Universitaria Colegios de Colombia

OTHER

Sponsor Role lead

Responsible Party

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Javier Caviedes-Bucheli

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Facultad de Odontologia, Unicoc

Bogotá, , Colombia

Site Status

Countries

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Colombia

References

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Basting RT, Amaral FL, Franca FM, Florio FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent. 2012 Sep-Oct;37(5):464-73. doi: 10.2341/11-337-C. Epub 2012 May 18.

Reference Type BACKGROUND
PMID: 22616927 (View on PubMed)

Bharti R, Wadhwani K. Spectrophotometric evaluation of peroxide penetration into the pulp chamber from whitening strips and gel: An in vitro study. J Conserv Dent. 2013 Mar;16(2):131-4. doi: 10.4103/0972-0707.108192.

Reference Type BACKGROUND
PMID: 23716964 (View on PubMed)

Buchalla W, Attin T. External bleaching therapy with activation by heat, light or laser--a systematic review. Dent Mater. 2007 May;23(5):586-96. doi: 10.1016/j.dental.2006.03.018. Epub 2006 Jul 3.

Reference Type BACKGROUND
PMID: 16820199 (View on PubMed)

Caviedes-Bucheli J, Munoz HR, Azuero-Holguin MM, Ulate E. Neuropeptides in dental pulp: the silent protagonists. J Endod. 2008 Jul;34(7):773-88. doi: 10.1016/j.joen.2008.03.010.

Reference Type BACKGROUND
PMID: 18570980 (View on PubMed)

Caviedes-Bucheli J, Ariza-Garcia G, Restrepo-Mendez S, Rios-Osorio N, Lombana N, Munoz HR. The effect of tooth bleaching on substance P expression in human dental pulp. J Endod. 2008 Dec;34(12):1462-5. doi: 10.1016/j.joen.2008.09.013. Epub 2008 Oct 31.

Reference Type BACKGROUND
PMID: 19026874 (View on PubMed)

Caviedes-Bucheli J, Gomez-Sosa JF, Azuero-Holguin MM, Ormeno-Gomez M, Pinto-Pascual V, Munoz HR. Angiogenic mechanisms of human dental pulp and their relationship with substance P expression in response to occlusal trauma. Int Endod J. 2017 Apr;50(4):339-351. doi: 10.1111/iej.12627. Epub 2016 Apr 2.

Reference Type BACKGROUND
PMID: 26953220 (View on PubMed)

Caviedes-Bucheli J, Lombana N, Azuero-Holguin MM, Munoz HR. Quantification of neuropeptides (calcitonin gene-related peptide, substance P, neurokinin A, neuropeptide Y and vasoactive intestinal polypeptide) expressed in healthy and inflamed human dental pulp. Int Endod J. 2006 May;39(5):394-400. doi: 10.1111/j.1365-2591.2006.01093.x.

Reference Type BACKGROUND
PMID: 16640639 (View on PubMed)

Caviedes-Bucheli J, Lopez-Moncayo LF, Munoz-Alvear HD, Hernandez-Acosta F, Pantoja-Mora M, Rodriguez-Guerrero AS, Lopez-Ordonez A, Diaz LE, Gomez-Sosa JF, Munoz HR. Expression of early angiogenesis indicators in mature versus immature teeth. BMC Oral Health. 2020 Nov 12;20(1):324. doi: 10.1186/s12903-020-01313-1.

Reference Type BACKGROUND
PMID: 33183306 (View on PubMed)

Donato MV, Dos Reis-Prado AH, Abreu LG, de Arantes LC, Goto J, Chaves HGDS, Cintra LTA, Briso ALF, Peixoto IFDC, Benetti F. Influence of dental bleaching on the pulp tissue: A systematic review of in vivo studies. Int Endod J. 2024 Jun;57(6):630-654. doi: 10.1111/iej.14061. Epub 2024 Mar 12.

Reference Type BACKGROUND
PMID: 38470103 (View on PubMed)

El-Karim I, Lundy FT, Linden GJ, Lamey PJ. Extraction and radioimmunoassay quantitation of neuropeptide Y (NPY) and vasoactive intestinal polypeptide (VIP) from human dental pulp tissue. Arch Oral Biol. 2003 Mar;48(3):249-54. doi: 10.1016/s0003-9969(02)00213-3.

Reference Type BACKGROUND
PMID: 12648563 (View on PubMed)

Farah RI, Elwi H. Spectrophotometric evaluation of color changes of bleach-shade resin-based composites after staining and bleaching. J Contemp Dent Pract. 2014 Sep 1;15(5):587-94. doi: 10.5005/jp-journals-10024-1584.

Reference Type BACKGROUND
PMID: 25707831 (View on PubMed)

Fernandes AMM, Vilela PGF, Valera MC, Bolay C, Hiller KA, Schweikl H, Schmalz G. Effect of bleaching agent extracts on murine macrophages. Clin Oral Investig. 2018 May;22(4):1771-1781. doi: 10.1007/s00784-017-2273-1. Epub 2017 Dec 1.

Reference Type BACKGROUND
PMID: 29196947 (View on PubMed)

Galler KM, Weber M, Korkmaz Y, Widbiller M, Feuerer M. Inflammatory Response Mechanisms of the Dentine-Pulp Complex and the Periapical Tissues. Int J Mol Sci. 2021 Feb 2;22(3):1480. doi: 10.3390/ijms22031480.

Reference Type BACKGROUND
PMID: 33540711 (View on PubMed)

Other Identifiers

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BIO407

Identifier Type: -

Identifier Source: org_study_id

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