Calcitonin Gene-related Peptide Expression in Human Periodontal Ligament

NCT04881786 | Completed

• 1 other identifier: JCB003
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

CGRP Expression in Human Periodontal Ligament

Keywords

Orthodontics forces; Calcitonin gene-related peptide; Periodontal ligament

Outcome Measures

Primary Outcomes (1)

• Calcitonin gene-related peptide in periodontal ligament

  CGRP expression change in periodontal ligament

  24 hours stimulation and 7 days stimulation

Study Arms (3)

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

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

Device: Orthodontic forces

Interventions

Orthodontic forces DEVICE

56g force and 224g force

Moderate force group; Severe force group

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Premolars extraction indicated for orthodontic reasons with complete root development determined radiographically (and confirmed visually after extraction)

You may not qualify if:

• Medicated patients,
• Smokers patients,
• Premolars with caries or restorations,
• Premolars with signs of periodontal disease or traumatic occlusion,
• Premolars with previous orthodontic forces

Sponsors & Collaborators

• Institucion Universitaria Colegios de Colombia: lead
• Universidad Santo Tomas: collaborator

Study Sites (1)

Universidad Santo Tomas

Bucaramanga, Metropolitana, Colombia

Location

Related Publications (12)

• 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.

  PMID: 9567922 BACKGROUND

• McCulloch 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.

  PMID: 11276873 BACKGROUND

• Lekic 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.

  PMID: 8769671 BACKGROUND

• Roberts WE, Goodwin WC Jr, Heiner SR. Cellular response to orthodontic force. Dent Clin North Am. 1981 Jan;25(1):3-17.

  PMID: 6937399 BACKGROUND

• Sandy 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.

  PMID: 8456777 BACKGROUND

• 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.

  PMID: 18570980 BACKGROUND

• Price 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.

  PMID: 16809002 BACKGROUND

• Vandevska-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.

  PMID: 10407533 BACKGROUND

• Caviedes-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.

  PMID: 21496661 BACKGROUND

• Krishnan 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.

  PMID: 19641146 BACKGROUND

• Caviedes-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.

  PMID: 21092809 BACKGROUND

• Caviedes-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.

  PMID: 21689547 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: June 4, 2019
• Primary Completion: November 7, 2019
• Study Completion: March 10, 2020
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)