NCT03804034

Brief 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 combination of these stimuli on their pulp tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2014

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2015

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

January 8, 2019

Last Update Submit

April 24, 2019

Conditions

Keywords

Neurogenic inflammationDental PulpOcclusal traumaOrthodontics forcesSPCGRPVEGF

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours stimulations

Secondary Outcomes (2)

  • CGRP expression (pmol/mg in pulp tissue)

    24 hours stimulations

  • VEGF expression (pmol/mg in pulp tissue)

    24 hours stimulations

Study Arms (4)

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

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.

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 .

Device: Block of resinDevice: 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

Interventions

Occlusal trauma and moderate orthodontic force groupOcclusal trauma group
Moderate orthodontic force groupOcclusal trauma and moderate orthodontic force group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Teeth in normal masticatory function
  • Complete root development verified clinically and radiographically

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Odontologia, Unicoc

Bogotá, Colombia

Location

Related Publications (10)

  • 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.

    PMID: 19157980BACKGROUND
  • Caviedes-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.

    PMID: 16164685BACKGROUND
  • 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: 21496661BACKGROUND
  • 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.

    PMID: 26953220BACKGROUND
  • 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.

    PMID: 16640639BACKGROUND
  • Saghiri 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.

    PMID: 25649306BACKGROUND
  • Wei 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.

    PMID: 26441483BACKGROUND
  • Potente 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.

    PMID: 21925313BACKGROUND
  • Awawdeh 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.

  • Caviedes-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.

MeSH Terms

Conditions

Neurogenic Inflammation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endodontics postgraduate program professor

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 15, 2019

Study Start

July 2, 2013

Primary Completion

January 27, 2014

Study Completion

January 12, 2015

Last Updated

April 26, 2019

Record last verified: 2019-04

Locations