Oxidative Stress and Opiorphin in Temporomandibular Disorders (ROStrO-TMD)
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|ClinicalTrials.gov Identifier: NCT03029494|
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : January 24, 2017
|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|
|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 Description:||It will be a single-blind interventional study (as placebo splint cannot be mistaken for a stabilization splint by a clinician).|
|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|
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
Other Name: ascorbic acid
No Intervention: Control group
determination of oxidative stress biomarkers and cortisol in saliva of healthy control subjects
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Iva Z Alajbeg, PhDfirstname.lastname@example.org|
|Contact: Ivan Z Alajbeg, PhDemail@example.com|
|School of Dental Medicine, University of Zagreb||Recruiting|
|Zagreb, N/A = Not Applicable, Croatia, 10000|
|Contact: Iva Z Alajbeg, PhD 00385917930164 firstname.lastname@example.org|
|Principal Investigator:||Iva Z Alajbeg, PhD||School of Dental Medicine, University of Zagreb|