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Oxidative Stress and Opiorphin in Temporomandibular Disorders

NCT03029494 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-01-24

No results posted yet for this study

Summary

The objective of this study is to quantify salivary oxidative stress biomarkers in patients with temporomandibular disorders and to quantify recently isolated endogenous peptide opiorphin in saliva of these patients. As chronic exposure to stress may cause hyperalgesia as a result of the stress response in the hypothalamic-pituitary-adrenal axis, aim is to test this as an underlying mechanism by correlating opiorphin and oxidative stress markers to salivary cortisol levels. The aim is to assess the association of oxidative stress salivary biomarkers with muscle and joint pain and to measure opiorphin, a potential biomarker of different pathological states.

Conditions

  • Temporomandibular Disorders

Interventions

DEVICE

stabilization splint

Hard acrylic type of splint with full coverage of occlusal surfaces of upper teeth, with a thickness of about 1.5 mm at the level of the first molar.

DRUG

Placebo Oral Tablet

sugar pill manufactured to mimic 1000 mg Vitamin C

DEVICE

placebo splint

Ineffectively designed oral appliance: an acrylic palatal plate will be used (without influence on occlusion, TMJ and masticatory muscles).

DIETARY_SUPPLEMENT

Vitamin C

1000 mg

Sponsors & Collaborators

  • Croatian Science Foundation

    lead OTHER_GOV

Principal Investigators

  • Iva Z Alajbeg, PhD · School of Dental Medicine, University of Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2018-09-30
Completion
2019-09-30
FDA Device
Yes

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03029494 on ClinicalTrials.gov