Evaluating the role of amitriptyline in chronic temporomandibular disorder management: a placebo-controlled trial

Temporomandibular chronic disorder, amitriptyline, splint therapy, pain reduction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17622685

Enrollment

Registered

2024-10-01

Start date

2015-09-21

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orofacial pain due to chronic temporomandibular disorder Oral Health

Interventions

Patients will be recruited from the Institute for Mobile Prosthetics, Faculty of Dentistry in Zagreb. Patients with pain lasting longer than 3 months and caused by a temporomandibular disorder will be

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 70 years old 2. Orofacial pain lasting longer than 3 months 3. A VAS outcome above 30 mm 4. Caused by a temporomandibular disorder

Exclusion criteria

Exclusion criteria: 1. Periodontal diseases 2. Partial dentures 3. Extensive fixed prosthetic works 4. Orthodontic braces 5. Mental or neurological disorders 6. Pregnancy 7. Heart disease 8. Drug allergy

Design outcomes

Primary

Measure	Time frame
The following primary outcome measures will be assessed at baseline and weeks 4 and 8: 1. Pain measured using the Visual Analogue Scale (VAS) 2. Quality of life measured using the Oral Health Impact Profile-14 (OHIP-14)	—

Secondary

Measure	Time frame
There are no secondary measures	—

Countries

Croatia

Contacts

Public ContactIva Ž. Alajbeg

ialajbeg@sfzg.hr+38514802125

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026