Neurogenic InflammationNCT06606236
Neuropeptide Y Regulates Neurogenic Pulp Inflammation
A study testing H2O2 at 35% for 8 minutes, H2O2 at 40% for 20 minutes and H2O2 at 25% plus cold blue light for 15 minutes in people with Neurogenic Inflammation and Dental Pulp Disease, run by Institucion Universitaria Colegios de Colombia at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Inflammation, Dental Pulp Disease
- What is being tested?
- H2O2 at 35% for 8 minutes, H2O2 at 40% for 20 minutes and H2O2 at 25% plus cold blue light for 15 minutes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 5 Feb 2024to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Evidence of periodontal disease,
- Traumatic occlusion
- Previous orthodontic force application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Neurogenic Inflammation, Dental Pulp Disease
- Being tested
- H2O2 at 35% for 8 minutes, H2O2 at 40% for 20 minutes, H2O2 at 25% plus cold blue light for 15 minutes
- Keywords
- NPY, Dental Pulp, Dental Bleaching, Neurogenic Inflammation
- Medical subject headings
- Neurogenic Inflammation, Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2O2 at 35% for 8 minutesOther
The investigators rigorously followed the manufacturer's instructions for all bleaching systems.
H2O2 at 40% for 20 minutesOther
The investigators rigorously followed the manufacturer's instructions for all bleaching systems.
H2O2 at 25% plus cold blue light for 15 minutesOther
The investigators rigorously followed the manufacturer's instructions for all bleaching systems.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The teeth were not exposed to dental bleaching agents (healthy pulps with normal/basal NPY values). n=10 |
| Pola Office system group | Experimental | Application of Pola office n=10 Receives: Other: H2O2 at 35% for 8 minutes |
| Opalescent Boost system group | Experimental | Application of Opalescent Boost n=10 Receives: Other: H2O2 at 40% for 20 minutes |
| Zoom system group | Experimental | Application of Zoom! n=10 Receives: Other: H2O2 at 25% plus cold blue light for 15 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropeptide Y expression
Measurement of the increase or not of NPY expression compared to the control group (teeth without intervention)
Measured: 8-20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start5 Feb 2024
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Neurogenic InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institucion Universitaria Colegios de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Caviedes-Bucheli, Institucion Universitaria Colegios de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606236
- Sponsor's protocol ID
- BIO407
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22616927Bharti 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.
PubMed 23716964Buchalla 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.
PubMed 16820199Caviedes-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.
PubMed 18570980Caviedes-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.
PubMed 19026874Caviedes-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.
PubMed 26953220Caviedes-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.
PubMed 16640639Caviedes-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.
PubMed 33183306Donato 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.
PubMed 38470103El-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.
PubMed 12648563Farah 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.
PubMed 25707831Fernandes 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.
PubMed 29196947Galler 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.
PubMed 33540711
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropeptide Y Regulates Tooth Bleaching Agent-induced Neurogenic Pulp Inflammation: An In-Vivo Study
- ClinicalTrials.gov ID
- NCT06606236
- Acronym / sponsor ID
- BIO407
- Conditions
- Neurogenic Inflammation, Dental Pulp Disease
- Keywords
- NPY, Dental Pulp, Dental Bleaching, Neurogenic Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institucion Universitaria Colegios de ColombiaUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The teeth were not exposed to dental bleaching agents (healthy pulps with normal/basal NPY values). n=10 |
| Pola Office system group | Experimental | Other: H2O2 at 35% for 8 minutesApplication of Pola office n=10 |
| Opalescent Boost system group | Experimental | Other: H2O2 at 40% for 20 minutesApplication of Opalescent Boost n=10 |
| Zoom system group | Experimental | Other: H2O2 at 25% plus cold blue light for 15 minutesApplication of Zoom! n=10 |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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),
Key exclusion criteria (3 listed)
- Evidence of periodontal disease,
- Traumatic occlusion
- Previous orthodontic force application.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H2O2 at 35% for 8 minutesThe investigators rigorously followed the manufacturer's instructions for all bleaching systems. | Other | Pola Office system group |
| H2O2 at 40% for 20 minutesThe investigators rigorously followed the manufacturer's instructions for all bleaching systems. | Other | Opalescent Boost system group |
| H2O2 at 25% plus cold blue light for 15 minutesThe investigators rigorously followed the manufacturer's instructions for all bleaching systems. | Other | Zoom system group |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 22616927Basting 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.
- Background: PubMed 23716964Bharti 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.
- Background: PubMed 16820199Buchalla 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.
- Background: PubMed 18570980Caviedes-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.
- Background: PubMed 19026874Caviedes-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.
- Background: PubMed 26953220Caviedes-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.
- Background: PubMed 16640639Caviedes-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.
- Background: PubMed 33183306Caviedes-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.
- Background: PubMed 38470103Donato 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.
- Background: PubMed 12648563El-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.
- Background: PubMed 25707831Farah 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.
- Background: PubMed 29196947Fernandes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H2O2 at 35% for 8 minutes, H2O2 at 40% for 20 minutes and H2O2 at 25% plus cold blue light for 15 minutes in people with Neurogenic Inflammation and Dental Pulp Disease, run by Institucion Universitaria Colegios de Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropeptide Y expression (time frame: 8-20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606236, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.