CGRP Expression in Human Periodontal LigamentNCT04881786
Calcitonin Gene-related Peptide Expression in Human Periodontal Ligament
A study testing Orthodontic forces in people with CGRP Expression in Human Periodontal Ligament, run by Institucion Universitaria Colegios de Colombia at 1 site in Colombia.
Trial summary
The purpose of this study was to quantify the effect of moderate and severe orthodontic forces on Calcitonin gene-related peptide expression in the healthy human periodontal ligament. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- CGRP Expression in Human Periodontal Ligament
- What is being tested?
- Orthodontic forces
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteColombia
- Study dates
- 4 Jun 2019to 10 Mar 2020
- 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
- Premolars extraction indicated for orthodontic reasons with complete root development determined radiographically (and confirmed visually after extraction)
Who cannot join
- Medicated patients,
- Smokers patients,
- Premolars with caries or restorations,
- Premolars with signs of periodontal disease or traumatic occlusion,
- Premolars with previous orthodontic forces
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Orthodontic Forces on Calcitonin Gene-related Peptide Expression in Human Periodontal Ligament
The purpose of this study was to quantify the effect of moderate and severe orthodontic forces on Calcitonin gene-related peptide expression in the healthy human periodontal ligament.
Methodology: 90 human periodontal ligament samples were obtained from healthy premolars where extraction was indicated for orthodontic reasons. Prior to extraction, teeth were divided into 3 groups of 30 samples each: I) Untreated teeth control group; II) Moderate force group: A 56 g force was applied to the premolars for 7 days; and III) Severe force group: A 224 g force was applied to the premolars for 24 hours. All periodontal ligament samples were processed and CGRP was measured by radioimmunoassay.
Read the detailed description
An experimental study was performed according to Colombian Ministry of Health recommendations regarding ethical issues in research involving human tissue. Written informed consent was obtained from each of the patients participating in the study (18-27 years old, healthy, not medicated, and nonsmoking human donors, with premolars extraction indicated for orthodontic reasons). All teeth used were caries- and restoration-free with complete root development determined radiographically (and confirmed visually after extraction), without signs of periodontal disease or traumatic occlusion, and without previous orthodontic forces.
Experimental procedure Periodontal ligament samples were obtained from 90 premolars that were randomly divided into 3 groups of 30 premolars each, as follows: I) Untreated teeth control group (without orthodontic forces); II) Moderate force group; III) Severe force group. Teeth in moderate and severe orthodontic force groups were submitted to tipping and extrusion orthodontic movements.
Orthodontic forces were applied following the exact same methodology that was used in a previous study (15), in which, prior to orthodontic force application, the occlusal surface of the first mandibular molar was raised with a block of resin (Filtek Z350, 3M Espe, Seefeld, Germany) until the premolars were out of occlusion. A convertible standard buccal tube (Orthorganizer, Carlsbad, CA) was bonded over the buccal face of the first molar with resin (Light Bond, Reliance Orthodontic Products Inc, Itasca, IL). An MBT slot size 0.022 bracket (Ref. 702-393 MC, Orthorganizer) was bonded over the buccal face of the premolars. One 0.0017 x 0.025 in titanium molybdenum alloy (TMA) 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 exerted a tipping and extrusive force on the premolar. For the teeth in the moderate force group, the activation angle was 45º with a force of 56 g. For the severe force group, the activation angle was 90º with a force of 224 g. For both groups, forces were measured with an orthodontic dynamometer. Once the force was measured, the free-end of the sectional arch was hooked to the bracket with a metallic ligature. Seven days after, the ligature, the sectional arch, the tube, and the resin block were removed in order to perform the extraction procedure.
All teeth were anesthetized with 1.8 mL 4% prilocaine without vasoconstrictor by infiltrative injection for upper premolars and inferior alveolar nerve block injection for lower premolars. Adequate pulpal anesthesia was ascertained with a negative response to an electronic pulp vitality test.
Sample collection Teeth in the control and orthodontic forces group were extracted 10 min after anesthetic application with conventional methods and without excessive injury to the periodontal ligament. Immediately after extraction, PDL samples were obtained from the entire length of the root with a periodontal curette, placed on an Eppendorf tube, snap-frozen in liquid nitrogen, and kept at -70°C until use.
Radioimmunoassay (RIA) PDL samples were defrosted without thermal shock, dried on a filter, and individually weighed on an analytical balance. Neuropeptide was extracted by adding 150 µL of 0.5 mol L-1 acetic acid and double boiling in a thermostat bath for 30 min in accordance with previously reported protocols (9,12,15,18-21).
CGRP expression was determined by competition binding assays using a human CGRP-RIA kit from Phoenix Peptide Pharmaceutical (Ref. RK-015-02, Belmont, CA). Fifty µL of each sample solution were incubated in polypropylene tubes at room temperature for 20 h with 100 µL of primary antibody and 100 µL of different CGRP concentrations (10 pg mL-1 -1280 pg mL-1). Then, 50 µL of 125I-CGRP was added and left incubate for another 24 h. Bound fractions were precipitated by the addition of 100 µL of a secondary antibody (Goat Anti- Rabbit IgG serum), 100 µL of normal rabbit serum, and 500 µL of RIA buffer containing 1% polyethylene glycol 4000. After 2 h of incubation at room temperature, tubes were spun at 3000 rpm for 45 min at 4º C. The supernatants were decanted, and pellet radioactivity was read on a Gamma Counter (Gamma Assay LS 5500; Beckman, Fullerton, CA). Standard curves of authentic peptide were made in buffers identical to the tissue extracts on semi-log graph paper.
Finally, analysis of the binding data assessed the amount of CGRP present in every sample, using the percentage of maximum binding (B/B0%) calculated for each unknown sample, reading across the graph to the point of intersection with the calibration curve, where the corresponding X-axis coordinate is equivalent to the concentration of peptide in the assayed sample.
Statistical analysis Values are presented as CGRP concentration in pmol per mg of PDL. Mean, standard deviation, medians, and maximum/minimum values are presented for each group. Kruskal Wallis test was performed to establish statistically significant differences between groups (P<0.05). LSD posthoc comparisons were also performed.
- Being tested
- Orthodontic forces
- Keywords
- Orthodontics forces, Calcitonin gene-related peptide, Periodontal ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic forcesDevice
56g force and 224g force
| Study group | Role | What they receive |
|---|---|---|
| Untreated teeth control group | No intervention | Premolars without orthodontic forces |
| Moderate force group | Experimental | Premolars were submitted to tipping and extrusion orthodontic movements, the activation angle was 45º with a force of 56 g. Forces were measured with an orthodontic dynamometer. For 7 days Receives: Device: Orthodontic forces |
| Severe force group | Experimental | Premolars were submitted to tipping and extrusion orthodontic movements, the activation angle was 90º with a force of 224 g. Forces were measured with an orthodontic dynamometer. For 24 hours Receives: Device: Orthodontic forces |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcitonin gene-related peptide in periodontal ligament
CGRP expression change in periodontal ligament
Measured: 24 hours stimulation and 7 days stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start4 Jun 2019
- Primary completion7 Nov 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for CGRP Expression in Human Periodontal LigamentStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- from 90 premolars that were randomly divided into 3 groups of 30 premolars each, as follows: I) Untreated teeth control group (without orthodontic forces); II) Moderate force group; III) Severe force group. Teeth in moderate and severe orthodontic force groups were submitted to tipping and extrusion orthodontic movements.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institucion Universitaria Colegios de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Santo Tomas
- Responsible party
- Principal investigator, Javier Caviedes-Bucheli, Institucion Universitaria Colegios de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881786
- Sponsor's protocol ID
- JCB003
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beertsen W, McCulloch CA, Sodek J. The periodontal ligament: a unique, multifunctional connective tissue. Periodontol 2000. 1997 Feb;13:20-40. doi: 10.1111/j.1600-0757.1997.tb00094.x. No abstract available.
PubMed 9567922McCulloch CA, Lekic P, McKee MD. Role of physical forces in regulating the form and function of the periodontal ligament. Periodontol 2000. 2000 Oct;24:56-72. doi: 10.1034/j.1600-0757.2000.2240104.x. No abstract available.
PubMed 11276873Lekic P, McCulloch CA. Periodontal ligament cell population: the central role of fibroblasts in creating a unique tissue. Anat Rec. 1996 Jun;245(2):327-41. doi: 10.1002/(SICI)1097-0185(199606)245:23.0.CO;2-R.
PubMed 8769671Roberts WE, Goodwin WC Jr, Heiner SR. Cellular response to orthodontic force. Dent Clin North Am. 1981 Jan;25(1):3-17.
PubMed 6937399Sandy JR, Farndale RW, Meikle MC. Recent advances in understanding mechanically induced bone remodeling and their relevance to orthodontic theory and practice. Am J Orthod Dentofacial Orthop. 1993 Mar;103(3):212-22. doi: 10.1016/0889-5406(93)70002-6.
PubMed 8456777Caviedes-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 18570980Price TJ, Flores CM, Cervero F, Hargreaves KM. The RNA binding and transport proteins staufen and fragile X mental retardation protein are expressed by rat primary afferent neurons and localize to peripheral and central axons. Neuroscience. 2006 Sep 15;141(4):2107-16. doi: 10.1016/j.neuroscience.2006.05.047. Epub 2006 Jun 30.
PubMed 16809002Vandevska-Radunovic V. Neural modulation of inflammatory reactions in dental tissues incident to orthodontic tooth movement. A review of the literature. Eur J Orthod. 1999 Jun;21(3):231-47. doi: 10.1093/ejo/21.3.231.
PubMed 10407533Caviedes-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 21496661Krishnan V, Davidovitch Z. On a path to unfolding the biological mechanisms of orthodontic tooth movement. J Dent Res. 2009 Jul;88(7):597-608. doi: 10.1177/0022034509338914.
PubMed 19641146Caviedes-Bucheli J, Azuero-Holguin MM, Gutierrez-Sanchez L, Higuerey-Bermudez F, Pereira-Nava V, Lombana N, Munoz HR. The effect of three different rotary instrumentation systems on substance P and calcitonin gene-related peptide expression in human periodontal ligament. J Endod. 2010 Dec;36(12):1938-42. doi: 10.1016/j.joen.2010.08.043. Epub 2010 Oct 15.
PubMed 21092809Caviedes-Bucheli J, Moreno JO, Ardila-Pinto J, Del Toro-Carreno HR, Saltarin-Quintero H, Sierra-Tapias CL, Macias-Gomez F, Ulate E, Lombana-Sanchez N, Munoz HR. The effect of orthodontic forces on calcitonin gene-related peptide expression in human dental pulp. J Endod. 2011 Jul;37(7):934-7. doi: 10.1016/j.joen.2011.03.035. Epub 2011 May 18.
PubMed 21689547
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orthodontic Forces on Calcitonin Gene-related Peptide Expression in Human Periodontal Ligament
- ClinicalTrials.gov ID
- NCT04881786
- Acronym / sponsor ID
- JCB003
- Keywords
- Orthodontics forces, Calcitonin gene-related peptide, Periodontal ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institucion Universitaria Colegios de ColombiaUniversity, hospital or other
- Collaborators
- Universidad Santo Tomas
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 11 May 2021 (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.
The purpose of this study was to quantify the effect of moderate and severe orthodontic forces on Calcitonin gene-related peptide expression in the healthy human periodontal ligament.
Methodology: 90 human periodontal ligament samples were obtained from healthy premolars where extraction was indicated for orthodontic reasons. Prior to extraction, teeth were divided into 3 groups of 30 samples each: I) Untreated teeth control group; II) Moderate force group: A 56 g force was applied to the premolars for 7 days; and III) Severe force group: A 224 g force was applied to the premolars for 24 hours. All periodontal ligament samples were processed and CGRP was measured by radioimmunoassay.
Detailed description
An experimental study was performed according to Colombian Ministry of Health recommendations regarding ethical issues in research involving human tissue. Written informed consent was obtained from each of the patients participating in the study (18-27 years old, healthy, not medicated, and nonsmoking human donors, with premolars extraction indicated for orthodontic reasons). All teeth used were caries- and restoration-free with complete root development determined radiographically (and confirmed visually after extraction), without signs of periodontal disease or traumatic occlusion, and without previous orthodontic forces.
Experimental procedure Periodontal ligament samples were obtained from 90 premolars that were randomly divided into 3 groups of 30 premolars each, as follows: I) Untreated teeth control group (without orthodontic forces); II) Moderate force group; III) Severe force group. Teeth in moderate and severe orthodontic force groups were submitted to tipping and extrusion orthodontic movements.
Orthodontic forces were applied following the exact same methodology that was used in a previous study (15), in which, prior to orthodontic force application, the occlusal surface of the first mandibular molar was raised with a block of resin (Filtek Z350, 3M Espe, Seefeld, Germany) until the premolars were out of occlusion. A convertible standard buccal tube (Orthorganizer, Carlsbad, CA) was bonded over the buccal face of the first molar with resin (Light Bond, Reliance Orthodontic Products Inc, Itasca, IL). An MBT slot size 0.022 bracket (Ref. 702-393 MC, Orthorganizer) was bonded over the buccal face of the premolars. One 0.0017 x 0.025 in titanium molybdenum alloy (TMA) 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 exerted a tipping and extrusive force on the premolar. For the teeth in the moderate force group, the activation angle was 45º with a force of 56 g. For the severe force group, the activation angle was 90º with a force of 224 g. For both groups, forces were measured with an orthodontic dynamometer. Once the force was measured, the free-end of the sectional arch was hooked to the bracket with a metallic ligature. Seven days after, the ligature, the sectional arch, the tube, and the resin block were removed in order to perform the extraction procedure.
All teeth were anesthetized with 1.8 mL 4% prilocaine without vasoconstrictor by infiltrative injection for upper premolars and inferior alveolar nerve block injection for lower premolars. Adequate pulpal anesthesia was ascertained with a negative response to an electronic pulp vitality test.
Sample collection Teeth in the control and orthodontic forces group were extracted 10 min after anesthetic application with conventional methods and without excessive injury to the periodontal ligament. Immediately after extraction, PDL samples were obtained from the entire length of the root with a periodontal curette, placed on an Eppendorf tube, snap-frozen in liquid nitrogen, and kept at -70°C until use.
Radioimmunoassay (RIA) PDL samples were defrosted without thermal shock, dried on a filter, and individually weighed on an analytical balance. Neuropeptide was extracted by adding 150 µL of 0.5 mol L-1 acetic acid and double boiling in a thermostat bath for 30 min in accordance with previously reported protocols (9,12,15,18-21).
CGRP expression was determined by competition binding assays using a human CGRP-RIA kit from Phoenix Peptide Pharmaceutical (Ref. RK-015-02, Belmont, CA). Fifty µL of each sample solution were incubated in polypropylene tubes at room temperature for 20 h with 100 µL of primary antibody and 100 µL of different CGRP concentrations (10 pg mL-1 -1280 pg mL-1). Then, 50 µL of 125I-CGRP was added and left incubate for another 24 h. Bound fractions were precipitated by the addition of 100 µL of a secondary antibody (Goat Anti- Rabbit IgG serum), 100 µL of normal rabbit serum, and 500 µL of RIA buffer containing 1% polyethylene glycol 4000. After 2 h of incubation at room temperature, tubes were spun at 3000 rpm for 45 min at 4º C. The supernatants were decanted, and pellet radioactivity was read on a Gamma Counter (Gamma Assay LS 5500; Beckman, Fullerton, CA). Standard curves of authentic peptide were made in buffers identical to the tissue extracts on semi-log graph paper.
Finally, analysis of the binding data assessed the amount of CGRP present in every sample, using the percentage of maximum binding (B/B0%) calculated for each unknown sample, reading across the graph to the point of intersection with the calibration curve, where the corresponding X-axis coordinate is equivalent to the concentration of peptide in the assayed sample.
Statistical analysis Values are presented as CGRP concentration in pmol per mg of PDL. Mean, standard deviation, medians, and maximum/minimum values are presented for each group. Kruskal Wallis test was performed to establish statistically significant differences between groups (P<0.05). LSD posthoc comparisons were also performed.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- from 90 premolars that were randomly divided into 3 groups of 30 premolars each, as follows: I) Untreated teeth control group (without orthodontic forces); II) Moderate force group; III) Severe force group. Teeth in moderate and severe orthodontic force groups were submitted to tipping and extrusion orthodontic movements.
| Arm | Type | Receives |
|---|---|---|
| Untreated teeth control group | No intervention | –Premolars without orthodontic forces |
| Moderate force group | Experimental | Device: Orthodontic forcesPremolars were submitted to tipping and extrusion orthodontic movements, the activation angle was 45º with a force of 56 g. Forces were measured with an orthodontic dynamometer. For 7 days |
| Severe force group | Experimental | Device: Orthodontic forcesPremolars were submitted to tipping and extrusion orthodontic movements, the activation angle was 90º with a force of 224 g. Forces were measured with an orthodontic dynamometer. For 24 hours |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Premolars extraction indicated for orthodontic reasons with complete root development determined radiographically (and confirmed visually after extraction)
Key exclusion criteria (5 listed)
- Medicated patients,
- Smokers patients,
- Premolars with caries or restorations,
- Premolars with signs of periodontal disease or traumatic occlusion,
- Premolars with previous orthodontic forces
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 |
|---|---|---|
| Orthodontic forces56g force and 224g force | Device | Moderate force group, Severe force group |
Primary outcome
Calcitonin gene-related peptide in periodontal ligament
Time frame: 24 hours stimulation and 7 days stimulation
CGRP expression change in periodontal ligament
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 13 May 2021.
- Background: PubMed 9567922Beertsen W, McCulloch CA, Sodek J. The periodontal ligament: a unique, multifunctional connective tissue. Periodontol 2000. 1997 Feb;13:20-40. doi: 10.1111/j.1600-0757.1997.tb00094.x. No abstract available.
- Background: PubMed 11276873McCulloch CA, Lekic P, McKee MD. Role of physical forces in regulating the form and function of the periodontal ligament. Periodontol 2000. 2000 Oct;24:56-72. doi: 10.1034/j.1600-0757.2000.2240104.x. No abstract available.
- Background: PubMed 8769671Lekic P, McCulloch CA. Periodontal ligament cell population: the central role of fibroblasts in creating a unique tissue. Anat Rec. 1996 Jun;245(2):327-41. doi: 10.1002/(SICI)1097-0185(199606)245:23.0.CO;2-R.
- Background: PubMed 6937399Roberts WE, Goodwin WC Jr, Heiner SR. Cellular response to orthodontic force. Dent Clin North Am. 1981 Jan;25(1):3-17.
- Background: PubMed 8456777Sandy JR, Farndale RW, Meikle MC. Recent advances in understanding mechanically induced bone remodeling and their relevance to orthodontic theory and practice. Am J Orthod Dentofacial Orthop. 1993 Mar;103(3):212-22. doi: 10.1016/0889-5406(93)70002-6.
- 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 16809002Price TJ, Flores CM, Cervero F, Hargreaves KM. The RNA binding and transport proteins staufen and fragile X mental retardation protein are expressed by rat primary afferent neurons and localize to peripheral and central axons. Neuroscience. 2006 Sep 15;141(4):2107-16. doi: 10.1016/j.neuroscience.2006.05.047. Epub 2006 Jun 30.
- Background: PubMed 10407533Vandevska-Radunovic V. Neural modulation of inflammatory reactions in dental tissues incident to orthodontic tooth movement. A review of the literature. Eur J Orthod. 1999 Jun;21(3):231-47. doi: 10.1093/ejo/21.3.231.
- 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 19641146Krishnan V, Davidovitch Z. On a path to unfolding the biological mechanisms of orthodontic tooth movement. J Dent Res. 2009 Jul;88(7):597-608. doi: 10.1177/0022034509338914.
- Background: PubMed 21092809Caviedes-Bucheli J, Azuero-Holguin MM, Gutierrez-Sanchez L, Higuerey-Bermudez F, Pereira-Nava V, Lombana N, Munoz HR. The effect of three different rotary instrumentation systems on substance P and calcitonin gene-related peptide expression in human periodontal ligament. J Endod. 2010 Dec;36(12):1938-42. doi: 10.1016/j.joen.2010.08.043. Epub 2010 Oct 15.
- Background: PubMed 21689547Caviedes-Bucheli J, Moreno JO, Ardila-Pinto J, Del Toro-Carreno HR, Saltarin-Quintero H, Sierra-Tapias CL, Macias-Gomez F, Ulate E, Lombana-Sanchez N, Munoz HR. The effect of orthodontic forces on calcitonin gene-related peptide expression in human dental pulp. J Endod. 2011 Jul;37(7):934-7. doi: 10.1016/j.joen.2011.03.035. Epub 2011 May 18.
- Individual participant dataSharing planned: No
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 Orthodontic forces in people with CGRP Expression in Human Periodontal Ligament, 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 1 inclusion and 5 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 13 May 2021. 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?
Calcitonin gene-related peptide in periodontal ligament (time frame: 24 hours stimulation and 7 days stimulation). 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 NCT04881786, which also lists 12 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 13 May 2021.