ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxidative Stress and Opiorphin in Temporomandibular Disorders (ROStrO-TMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03029494
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Iva Alajbeg, University of Zagreb

Brief 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.

Condition or disease Intervention/treatment Phase
Temporomandibular Disorders Device: stabilization splint Drug: Placebo Oral Tablet Device: placebo splint Dietary Supplement: Vitamin C Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

TMD patients will be randomized into two treatment groups. Each group will have two sets of interventions: one presumably active treatment and other a placebo:

Treatment group 1: stabilization splint and placebo tablet daily. Treatment group 2: placebo (ineffectively designed) splint and 1000 mg Vitamin C tablet (an antioxidant agent) daily.

Masking: Single (Participant)
Masking Description: It will be a single-blind interventional study (as placebo splint cannot be mistaken for a stabilization splint by a clinician).
Primary Purpose: Diagnostic
Official Title: The Role of Oxidative Stress and Opiorphin in Temporomandibular Disorders
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment 1: stabilization splint, placebo oral tablet
stabilization splint during night and 1 placebo oral tablet daily, for 6 months
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.
Other Name: occlusal splint

Drug: Placebo Oral Tablet
sugar pill manufactured to mimic 1000 mg Vitamin C

Active Comparator: Treatment 2: placebo splint, vitamin C
placebo splint during night and 1000 mg Vitamin C tablet daily, for 6 months
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
Other Name: ascorbic acid

No Intervention: Control group
determination of oxidative stress biomarkers and cortisol in saliva of healthy control subjects



Primary Outcome Measures :
  1. Change of salivary oxidative stress markers concentration [ Time Frame: baseline, 6th month ]

    Oxidative stress markers will be measured using spectrophotometric methods. Opiorphin levels will be measured by HPLC-MS/MS method, originally developed and validated by team members (Brkljacic L, Sabalic M, Salaric I, Jeric I, Alajbeg I et al, J Chromatogr B Analyt Technol Biomed Life Sci. 2011). The change of the single marker (opiorphin) concentration between the two time points is a measure of clinical efficacy of applied treatment modality.

    In control group (healthy patients) measurement of oxidative stress markers and opiorphin will be performed only at first appointment in order to compare them with TMD patients baseline levels.



Secondary Outcome Measures :
  1. Change of pain intensity in TMD patients [ Time Frame: baseline, 3rd month, 6th month ]
    The intensity of pain will be determined using a 100 mm visual analog scale (VAS) on day 0, day 90 and day 180. The change in the amount between the time points is a measure of clinical efficacy of applied treatment modality.

  2. The quality of life change in TMD patients [ Time Frame: baseline, 6th month ]
    The quality of life for OLP patients will be determined using "Oral health impact profile"(OHIP-14) questionnaire on day 0 and day 180. The change in the amount between the time points is a measure of clinical efficacy of applied treatment modality.

  3. Change in the amount of maximal comfortable mouth opening in TMD patients [ Time Frame: baseline, 6th month ]
    Maximal comfortable mouth opening is measured as the distance between the maxillary and mandibular incisal edges. Maximal comfortable opening is defined as the maximum distance the participant could open his/her mouth without experiencing any additional pain and discomfort. The change in the amount of maximal comfortable mouth opening between the time points is a measure of clinical efficacy of applied treatment modality.

  4. Change in the perceived stress [ Time Frame: baseline, 6th month ]
    General anxiety disorder (GAD - 7) scale will be used in order to determine how often the patient has been disturbed by different problems including feeling of nervousness and anxiety. The change in the amount between the time points is a measure of clinical efficacy of applied treatment modality. In control group (healthy patients) GAD-7 will be used only at first appointment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • for TMD patients: diagnosis of TMD using Croatian version of research diagnostic criteria for temporomandibular disorders (RDC/TMD)
  • for control group: gender- and age-matched healthy volunteers

Exclusion Criteria:

  • for TMD patients: patients younger than 18 years; smoking; other local diseases and/or systemic disorders; the use of anti-inflammatory drugs, analgesics and/or muscle relaxants; individuals who had already been under treatment for TMD
  • for control group: younger than 18 years; cardiac/circulatory/metabolic/muscle abnormalities; smoking; the use of medications, supplements or dietary aids that might affect the outcome results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03029494


Contacts
Contact: Iva Z Alajbeg, PhD 00385917930164 ialajbeg@sfzg.hr
Contact: Ivan Z Alajbeg, PhD 00385915051271 alajbeg@sfzg.hr

Locations
Croatia
School of Dental Medicine, University of Zagreb Recruiting
Zagreb, N/A = Not Applicable, Croatia, 10000
Contact: Iva Z Alajbeg, PhD    00385917930164    ialajbeg@sfzg.hr   
Sponsors and Collaborators
Croatian Science Foundation
Investigators
Principal Investigator: Iva Z Alajbeg, PhD School of Dental Medicine, University of Zagreb

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Iva Alajbeg, Prof., University of Zagreb
ClinicalTrials.gov Identifier: NCT03029494     History of Changes
Other Study ID Numbers: IP- 2014-09-3070
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Iva Alajbeg, University of Zagreb:
oxidative stress
saliva

Additional relevant MeSH terms:
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Pathologic Processes
Myofascial Pain Syndromes
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents