Occlusal TraumaNCT03804034
Importance of Neurogenic Inflammation in the Angiogenic Response of the Dental Pulp as a Defensive Response
A study testing Block of resin and Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wire in people with Occlusal Trauma and Orthodontic Appliance Complication, run by Institucion Universitaria Colegios de Colombia at 1 site in Colombia.
Trial summary
This study measures SP, CGRP and VEGF expression in human dental pulp under occlusal trauma induced by occlusal interferences under moderate orthodontic forces or under a combination of occlusal trauma and moderate orthodontic forces because in clinical reality, patients under orthodontic treatment experience a… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Occlusal Trauma, Orthodontic Appliance Complication
- What is being tested?
- Block of resin and Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteColombia
- Study dates
- 2 Jul 2013to 12 Jan 2015
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Teeth in normal masticatory function
- Complete root development verified clinically and radiographically
Who cannot join
- Patients under medication
- Smokers
- Pregnant women were excluded
- Teeth with caries
- Teeth with restaurations,
- Teeth with previous orthodontic treatment
- Teeth with periodontal disorders
- Teeth with parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurogenic Inflammation and Angiogenesis in the Human Dental Pulp in Response to Occlusal Interferences and Orthodontic Movements
This study measures SP, CGRP and VEGF expression in human dental pulp under occlusal trauma induced by occlusal interferences under moderate orthodontic forces or under a combination of occlusal trauma and moderate orthodontic forces because in clinical reality, patients under orthodontic treatment experience a combination of these stimuli on their pulp tissue.
Read the detailed description
Substance P (SP) and calcitonin gene-related peptide (CGRP) are neuropeptides that are assembled in the cell bodies of the trigeminal nerve and are transported through axonal flow to the nerve endings in human dental pulp, mainly in type-C nerve fibers and free nerve endings, where they are released to fulfill important biological functions.
SP plays an important role in pulp tissue reparation because it stimulates angiogenesis using direct mechanisms by modulating the growth of endothelial cells and fibroblasts through the activation of growth factors such as VEGF and IGF-1 and stimulates cell migration and proliferation to form mineralized tissue as a defense mechanism. It also uses indirect mechanisms such as binding to granulocytes or macrophages, which allow cells with angiogenic potential to be attracted.
CGRP has a key role in pulp reparation because of its angiogenic potential, which is linked to endothelial cell stimulation via the cAMP-PKA pathway, promoting cell proliferation. It boosts VEGF expression and stimulates focal adhesion kinase involved in the stabilization and maturation of blood vessels. It can stimulate growth factors that act on fibroblasts, such as HGF, IGF-1, and bFGF, and it can also produce an effect on odontoblast-like cells by increasing BMP-2 expression and allowing cell proliferation after 24 h. This shows that it can contribute to mineralized matrix formation
Angiogenesis is mediated by several growth factors, such as the VEGF. VEGF is released in the pulp tissue as a response to a harmful stimulus to counteract emerging hypoxic areas regulating oxygen and nutrients supply to cell populations by forming new blood vessels. VEGF is present in endothelial cells, mast cells, macrophages, lymphocytes, undifferentiated mesenchymal cells, fibroblasts, and odontoblast-like cells, and it controls neurogenic inflammation and reparation processes in combination with SP due to its angiogenic potential.
SP, CGRP, VEGF expression can be altered by the masticatory function, occlusal trauma, orthodontic movements, or a combination of occlusal trauma and orthodontic movements, which often takes place in patients under orthodontic treatment.
- Being tested
- Block of resin, Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wire
- Keywords
- Neurogenic inflammation, Dental Pulp, Occlusal trauma, Orthodontics forces, SP, CGRP, VEGF
- Medical subject headings
- Neurogenic Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block of resinDevice
Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wireDevice
| Study group | Role | What they receive |
|---|---|---|
| Occlusal trauma group | Experimental | an occlusal interference was placed on the lower teeth as follows. Articulating paper was used to mark the contact area between the upper and lower premolars indicated for extraction. Once established, the marked area on the lower premolar was acid-etched with 37% phosphoric acid for 15 s, washed, and dried. A bonding agent was placed and light-cured for 15 s, and finally, a 1- to 2-mm block of resin was placed over the contact area and light-cured for 40 s. Articulating paper was used again to verify that only the premolars that were going to be extracted had contact during normal occlusion as well as in lateral movements. Patients were given chewing gum and indications to repeat 20 masticatory cycles for 30 s, followed by a 30-s rest interval, and repeat the sequence again for a period of 30 min. This chewing cycle was repeated three times every 8 h for the first 24 h Receives: Device: Block of resin |
| Moderate orthodontic force group | Experimental | A convertible standard buccal tube was bonded over the buccal face of the first molar with resin and a McLaughlin, Bennett, and Trevisi slot size 0.022 bracket was bonded over the buccal face of the premolars. One 0.0017 × 0.025 in titanium molybdenum alloy wire cantilever was inserted into each first molar tube, and the wire was bent buccally to form a helix. The cantilever was clinched to the distal end of the tube, and a tipping and extrusive force was applied on the premolar. The activation angle was 45° with a force of 56 g, which was applied to the tooth for 24 h before it was extracted. Receives: Device: Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wire |
| Occlusal trauma and moderate orthodontic force group | Experimental | the combination of occlusal trauma and orthodontic force . Receives: Device: Block of resin; Device: Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wire |
| Control Group | No intervention | No experimental device to produce occlusal trauma or orthodontic forces |
What is being measured
The primary outcome is the main question the study is designed to answer.
SP expression (pmol/mg in pulp tissue)
Sample Collection: All the teeth involved in this study were anesthetized and extracted 5 min after anesthetic application with conventional methods. Immediately after extraction, teeth were sectioned. Pulp tissue was obtained using a sterile endodontic excavator, placed on an Eppendorf tube, snap frozen in liquid nitrogen until the radioimmunoassay (RIA) test was performed.
Results are presented as SP expression in pmol/mg of pulp tissue. Means and standard deviations as well as minimum and maximum values for each neuropeptide were calculated.
Measured: 24 hours stimulations
Secondary outcomes (2)
CGRP expression (pmol/mg in pulp tissue)
Sample Collection: All the teeth involved in this study were anesthetized and extracted 5 min after anesthetic application with conventional methods. Immediately after extraction, teeth were sectioned. Pulp tissue was obtained using a sterile endodontic excavator, placed on an Eppendorf tube, snap frozen in liquid nitrogen until the radioimmunoassay (RIA) test was performed.
Results are presented as CGRP expression in pmol/mg of pulp tissue. Means and standard deviations as well as minimum and maximum values for each neuropeptide were calculated.
Measured: 24 hours stimulations
VEGF expression (pmol/mg in pulp tissue)
Sample Collection: All the teeth involved in this study were anesthetized and extracted 5 min after anesthetic application with conventional methods. Immediately after extraction, teeth were sectioned. Pulp tissue was obtained using a sterile endodontic excavator, placed on an Eppendorf tube, snap frozen in liquid nitrogen until the radioimmunoassay (RIA) test was performed.
Results are presented as CGRP expression in pmol/mg of pulp tissue. Means and standard deviations as well as minimum and maximum values for each growth factor were calculated.
Measured: 24 hours stimulations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start2 Jul 2013
- Primary completion27 Jan 2014
- Study completion12 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Occlusal TraumaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Human dental pulp was obtained from 40 freshly extracted maxillary and mandibular premolars with orthodontic indication from 20 healthy patients, both male and female, aged between 18 and 30 yearsThe premolars were randomly distributed into four groups, namely a group without occlusal trauma and orthodontic force chosen as the control group and three experimental groups, i.e., one occlusal trauma group experimentally induced by occlusal interferences, one moderate orthodontic force group, and one occlusal trauma plus moderate orthodontic force group.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institucion Universitaria Colegios de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Cooperativa de Colombia seccional Pasto
- Responsible party
- Principal investigator, Javier Caviedes-Bucheli, Cooperative University of Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804034
- Sponsor's protocol ID
- JCB002
- Status last verified
- Apr 2019
- First submitted
- 8 Jan 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Benemei S, Nicoletti P, Capone JG, Geppetti P. CGRP receptors in the control of pain and inflammation. Curr Opin Pharmacol. 2009 Feb;9(1):9-14. doi: 10.1016/j.coph.2008.12.007. Epub 2009 Jan 20.
PubMed 19157980Caviedes-Bucheli J, Arenas N, Guiza O, Moncada NA, Moreno GC, Diaz E, Munoz HR. Calcitonin gene-related peptide receptor expression in healthy and inflamed human pulp tissue. Int Endod J. 2005 Oct;38(10):712-7. doi: 10.1111/j.1365-2591.2005.01006.x.
PubMed 16164685Caviedes-Bucheli J, Azuero-Holguin MM, Correa-Ortiz JA, Aguilar-Mora MV, Pedroza-Flores JD, Ulate E, Lombana N, Munoz HR. Effect of experimentally induced occlusal trauma on substance p expression in human dental pulp and periodontal ligament. J Endod. 2011 May;37(5):627-30. doi: 10.1016/j.joen.2011.02.013.
PubMed 21496661Caviedes-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 16640639Saghiri MA, Asatourian A, Sorenson CM, Sheibani N. Role of angiogenesis in endodontics: contributions of stem cells and proangiogenic and antiangiogenic factors to dental pulp regeneration. J Endod. 2015 Jun;41(6):797-803. doi: 10.1016/j.joen.2014.12.019. Epub 2015 Jan 31.
PubMed 25649306Wei F, Yang S, Xu H, Guo Q, Li Q, Hu L, Liu D, Wang C. Expression and Function of Hypoxia Inducible Factor-1alpha and Vascular Endothelial Growth Factor in Pulp Tissue of Teeth under Orthodontic Movement. Mediators Inflamm. 2015;2015:215761. doi: 10.1155/2015/215761. Epub 2015 Sep 9.
PubMed 26441483Potente M, Gerhardt H, Carmeliet P. Basic and therapeutic aspects of angiogenesis. Cell. 2011 Sep 16;146(6):873-87. doi: 10.1016/j.cell.2011.08.039.
PubMed 21925313Awawdeh L, Lundy FT, Shaw C, Lamey PJ, Linden GJ, Kennedy JG. Quantitative analysis of substance P, neurokinin A and calcitonin gene-related peptide in pulp tissue from painful and healthy human teeth. Int Endod J. 2002 Jan;35(1):30-6. doi: 10.1046/j.1365-2591.2002.00451.x.
PubMed 11853236Caviedes-Bucheli J, Lopez-Moncayo LF, Munoz-Alvear HD, Gomez-Sosa JF, Diaz-Barrera LE, Curtidor H, Munoz HR. Expression of substance P, calcitonin gene-related peptide and vascular endothelial growth factor in human dental pulp under different clinical stimuli. BMC Oral Health. 2021 Mar 23;21(1):152. doi: 10.1186/s12903-021-01519-x.
PubMed 33757513
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurogenic Inflammation and Angiogenesis in the Human Dental Pulp in Response to Occlusal Interferences and Orthodontic Movements
- ClinicalTrials.gov ID
- NCT03804034
- Acronym / sponsor ID
- JCB002
- Keywords
- Neurogenic inflammation, Dental Pulp, Occlusal trauma, Orthodontics forces, SP, CGRP, VEGF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institucion Universitaria Colegios de ColombiaUniversity, hospital or other
- Collaborators
- Universidad Cooperativa de Colombia seccional Pasto
- Study start
- 2 Jul 2013 (actual)
- Primary completion
- 27 Jan 2014 (actual)
- Study completion
- 12 Jan 2015 (actual)
- First posted
- 15 Jan 2019 (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.
This study measures SP, CGRP and VEGF expression in human dental pulp under occlusal trauma induced by occlusal interferences under moderate orthodontic forces or under a combination of occlusal trauma and moderate orthodontic forces because in clinical reality, patients under orthodontic treatment experience a combination of these stimuli on their pulp tissue.
Detailed description
Substance P (SP) and calcitonin gene-related peptide (CGRP) are neuropeptides that are assembled in the cell bodies of the trigeminal nerve and are transported through axonal flow to the nerve endings in human dental pulp, mainly in type-C nerve fibers and free nerve endings, where they are released to fulfill important biological functions.
SP plays an important role in pulp tissue reparation because it stimulates angiogenesis using direct mechanisms by modulating the growth of endothelial cells and fibroblasts through the activation of growth factors such as VEGF and IGF-1 and stimulates cell migration and proliferation to form mineralized tissue as a defense mechanism. It also uses indirect mechanisms such as binding to granulocytes or macrophages, which allow cells with angiogenic potential to be attracted.
CGRP has a key role in pulp reparation because of its angiogenic potential, which is linked to endothelial cell stimulation via the cAMP-PKA pathway, promoting cell proliferation. It boosts VEGF expression and stimulates focal adhesion kinase involved in the stabilization and maturation of blood vessels. It can stimulate growth factors that act on fibroblasts, such as HGF, IGF-1, and bFGF, and it can also produce an effect on odontoblast-like cells by increasing BMP-2 expression and allowing cell proliferation after 24 h. This shows that it can contribute to mineralized matrix formation
Angiogenesis is mediated by several growth factors, such as the VEGF. VEGF is released in the pulp tissue as a response to a harmful stimulus to counteract emerging hypoxic areas regulating oxygen and nutrients supply to cell populations by forming new blood vessels. VEGF is present in endothelial cells, mast cells, macrophages, lymphocytes, undifferentiated mesenchymal cells, fibroblasts, and odontoblast-like cells, and it controls neurogenic inflammation and reparation processes in combination with SP due to its angiogenic potential.
SP, CGRP, VEGF expression can be altered by the masticatory function, occlusal trauma, orthodontic movements, or a combination of occlusal trauma and orthodontic movements, which often takes place in patients under orthodontic treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Human dental pulp was obtained from 40 freshly extracted maxillary and mandibular premolars with orthodontic indication from 20 healthy patients, both male and female, aged between 18 and 30 yearsThe premolars were randomly distributed into four groups, namely a group without occlusal trauma and orthodontic force chosen as the control group and three experimental groups, i.e., one occlusal trauma group experimentally induced by occlusal interferences, one moderate orthodontic force group, and one occlusal trauma plus moderate orthodontic force group.
| Arm | Type | Receives |
|---|---|---|
| Occlusal trauma group | Experimental | Device: Block of resinan occlusal interference was placed on the lower teeth as follows. Articulating paper was used to mark the contact area between the upper and lower premolars indicated for extraction. Once established, the marked area on the lower premolar was acid-etched with 37% phosphoric acid for 15 s, washed, and dried. A bonding agent was placed and light-cured for 15 s, and finally, a 1- to 2-mm block of resin was placed over the contact area and light-cured for 40 s. Articulating paper was used again to verify that only the premolars that were going to be extracted had contact during normal occlusion as well as in lateral movements. Patients were given chewing gum and indications to repeat 20 masticatory cycles for 30 s, followed by a 30-s rest interval, and repeat the sequence again for a period of 30 min. This chewing cycle was repeated three times every 8 h for the first 24 h |
| Moderate orthodontic force group | Experimental | Device: Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wireA convertible standard buccal tube was bonded over the buccal face of the first molar with resin and a McLaughlin, Bennett, and Trevisi slot size 0.022 bracket was bonded over the buccal face of the premolars. One 0.0017 × 0.025 in titanium molybdenum alloy wire cantilever was inserted into each first molar tube, and the wire was bent buccally to form a helix. The cantilever was clinched to the distal end of the tube, and a tipping and extrusive force was applied on the premolar. The activation angle was 45° with a force of 56 g, which was applied to the tooth for 24 h before it was extracted. |
| Occlusal trauma and moderate orthodontic force group | Experimental | Device: Block of resin, Device: Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wirethe combination of occlusal trauma and orthodontic force . |
| Control Group | No intervention | –No experimental device to produce occlusal trauma or orthodontic forces |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Teeth in normal masticatory function
- Complete root development verified clinically and radiographically
Key exclusion criteria (8 listed)
- Patients under medication
- Smokers
- Pregnant women were excluded
- Teeth with caries
- Teeth with restaurations,
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 |
|---|---|---|
| Block of resin | Device | Occlusal trauma and moderate orthodontic force group, Occlusal trauma group |
| Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wire | Device | Moderate orthodontic force group, Occlusal trauma and moderate orthodontic force group |
Primary outcome
SP expression (pmol/mg in pulp tissue)
Time frame: 24 hours stimulations
Sample Collection: All the teeth involved in this study were anesthetized and extracted 5 min after anesthetic application with conventional methods. Immediately after extraction, teeth were sectioned. Pulp tissue was obtained using a sterile endodontic excavator, placed on an Eppendorf tube, snap frozen in liquid nitrogen until the radioimmunoassay (RIA) test was performed. Results are presented as SP expression in pmol/mg of pulp tissue. Means and standard deviations as well as minimum and maximum values for each neuropeptide were calculated.
2 secondary outcomes
CGRP expression (pmol/mg in pulp tissue)
Time frame: 24 hours stimulations
VEGF expression (pmol/mg in pulp tissue)
Time frame: 24 hours stimulations
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 26 Apr 2019.
- Background: PubMed 19157980Benemei S, Nicoletti P, Capone JG, Geppetti P. CGRP receptors in the control of pain and inflammation. Curr Opin Pharmacol. 2009 Feb;9(1):9-14. doi: 10.1016/j.coph.2008.12.007. Epub 2009 Jan 20.
- Background: PubMed 16164685Caviedes-Bucheli J, Arenas N, Guiza O, Moncada NA, Moreno GC, Diaz E, Munoz HR. Calcitonin gene-related peptide receptor expression in healthy and inflamed human pulp tissue. Int Endod J. 2005 Oct;38(10):712-7. doi: 10.1111/j.1365-2591.2005.01006.x.
- Background: PubMed 21496661Caviedes-Bucheli J, Azuero-Holguin MM, Correa-Ortiz JA, Aguilar-Mora MV, Pedroza-Flores JD, Ulate E, Lombana N, Munoz HR. Effect of experimentally induced occlusal trauma on substance p expression in human dental pulp and periodontal ligament. J Endod. 2011 May;37(5):627-30. doi: 10.1016/j.joen.2011.02.013.
- 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 25649306Saghiri MA, Asatourian A, Sorenson CM, Sheibani N. Role of angiogenesis in endodontics: contributions of stem cells and proangiogenic and antiangiogenic factors to dental pulp regeneration. J Endod. 2015 Jun;41(6):797-803. doi: 10.1016/j.joen.2014.12.019. Epub 2015 Jan 31.
- Background: PubMed 26441483Wei F, Yang S, Xu H, Guo Q, Li Q, Hu L, Liu D, Wang C. Expression and Function of Hypoxia Inducible Factor-1alpha and Vascular Endothelial Growth Factor in Pulp Tissue of Teeth under Orthodontic Movement. Mediators Inflamm. 2015;2015:215761. doi: 10.1155/2015/215761. Epub 2015 Sep 9.
- Background: PubMed 21925313Potente M, Gerhardt H, Carmeliet P. Basic and therapeutic aspects of angiogenesis. Cell. 2011 Sep 16;146(6):873-87. doi: 10.1016/j.cell.2011.08.039.
- Results publication: PubMed 11853236Awawdeh L, Lundy FT, Shaw C, Lamey PJ, Linden GJ, Kennedy JG. Quantitative analysis of substance P, neurokinin A and calcitonin gene-related peptide in pulp tissue from painful and healthy human teeth. Int Endod J. 2002 Jan;35(1):30-6. doi: 10.1046/j.1365-2591.2002.00451.x.
- Derived from this study: PubMed 33757513Caviedes-Bucheli J, Lopez-Moncayo LF, Munoz-Alvear HD, Gomez-Sosa JF, Diaz-Barrera LE, Curtidor H, Munoz HR. Expression of substance P, calcitonin gene-related peptide and vascular endothelial growth factor in human dental pulp under different clinical stimuli. BMC Oral Health. 2021 Mar 23;21(1):152. doi: 10.1186/s12903-021-01519-x.
- Individual participant dataSharing planned: Undecided
Related trials for Occlusal Trauma
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
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 Block of resin and Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wire in people with Occlusal Trauma and Orthodontic Appliance Complication, 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 2 inclusion and 8 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 26 Apr 2019. 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?
SP expression (pmol/mg in pulp tissue) (time frame: 24 hours stimulations). 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 NCT03804034, which also lists 10 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 26 Apr 2019.