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NCT03029494: ROStrO-TMD
Oxidative Stress and Opiorphin in Temporomandibular Disorders
NA trial testing stabilization splint in Temporomandibular Disorders in 80 participants. Status unknown.
30 September 2018
Quick facts
| Lead sponsor | Croatian Science Foundation |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 80 |
| Start date | 1 October 2015 |
| Primary completion | 30 September 2018 |
| Estimated completion | 30 September 2019 |
| Sites | 1 location across Croatia |
Drugs / interventions tested
- stabilization splint
- Placebo Oral Tablet — full drug profile →
- placebo splint
- Vitamin C — full drug profile →
Conditions studied
- Temporomandibular Disorders — all drugs for Temporomandibular Disorders →
Sponsor
Croatian Science Foundation
Who can join
Adults 18 to 75, any sex, with Temporomandibular Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effect of occlusal splint on oxidative stress markers and psychological aspects of chronic temporomandibular pain: a randomized controlled trial.
Alajbeg IZ, Vrbanović E, Lapić I, Alajbeg I, et al · · 2020 · cited 24× · PMID 32620810 · DOI 10.1038/s41598-020-67383-x -
Occlusal interventions for managing temporomandibular disorders.
Singh BP, Singh N, Jayaraman S, Kirubakaran R, et al · · 2024 · cited 22× · PMID 39282765 · DOI 10.1002/14651858.cd012850.pub2 -
Within-Subject Reliability and between-Subject Variability of Oxidative Stress Markers in Saliva of Healthy Subjects: A Longitudinal Pilot Study.
Alajbeg IZ, Lapić I, Rogić D, Vuletić L, et al · · 2017 · cited 20× · PMID 29269980 · DOI 10.1155/2017/2697464 -
Changes in salivary oxidative status, salivary cortisol, and clinical symptoms in female patients with temporomandibular disorders during occlusal splint therapy: a 3-month follow up.
Vrbanović E, Lapić I, Rogić D, Alajbeg IZ. · · 2019 · cited 14× · PMID 31170954 · DOI 10.1186/s12903-019-0791-8
Verify or expand the search:
- PubMed search for NCT03029494
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of stabilization splint
Trials testing the same drug.
- NCT06781320 — Digital Occlusal Analysis and Enamel Wear Assessment in Temporomandibular Disorder Patients Treated with Fully Digital V · NA · not yet recruiting
- NCT05548894 — Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction · NA · completed
- NCT04694274 — Genetic Polymorphisms and Their Association With Temporomandibular Disorders · unknown
- NCT04524806 — Influence of Stabilization Splint Thickness on The Temporomandibular Disorders · NA · completed
Other recruiting trials for Temporomandibular Disorders
Currently open trials in the same condition.
- NCT07452510 — Comparison of Dry Needling and Two Botulinum Toxins for Bruxism · NA · active not recruiting
- NCT06553950 — Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular · NA · recruiting
- NCT05720065 — Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A · Phase 2 · recruiting
Other Croatian Science Foundation trials
Trials by the same sponsor.
- NCT04694274 — Genetic Polymorphisms and Their Association With Temporomandibular Disorders · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03029494 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Croatian Science Foundation
- Last refreshed: 24 January 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03029494.
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