Evaluating the role of amitriptyline in chronic temporomandibular disorder management: a placebo-controlled trial
| ISRCTN | ISRCTN17622685 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17622685 |
| Secondary identifying numbers | No. IP-2014-09-3070, 643-03/19-02/33 |
- Submission date
- 26/09/2024
- Registration date
- 01/10/2024
- Last edited
- 05/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
The study will aim to assess the effectiveness of low-dose amitriptyline in reducing pain and improving oral health-related quality of life in individuals with chronic temporomandibular disorders (TMD) over 2 months, compared to a placebo.
Who can participate?
Everyone who meets the inclusion criteria will be eligible to participate in the study.
What does the study involve?
Participants will receive either low-dose amitriptyline or a placebo. The study will compare the effects of the medication on pain reduction and quality of life improvement.
What are the possible benefits and risks of participating?
Participants may experience a reduction in pain and an improvement in quality of life. However, the medication may have side effects, including potential mood changes.
Where is the study run from?
School of Dental Medicine, University of Zagreb
When is the study starting and how long is it expected to run for?
June 2015 to June 2018
Who is funding the study?
Investigator initiated and funded
Croatian Science Foundation
Who is the main contact?
Iva Ž. Alajbeg, ialajbeg@sfzg.hr
Contact information
Public, Scientific, Principal Investigator
Gundulićeva 5
Zagreb
10000
Croatia
 ORCID ID |
0000-0001-8524-5661 |
|---|---|
| Phone | +38514802125 |
| ialajbeg@sfzg.hr |
Study information
| Study design | Interventional double-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Temporomandibular chronic disorder, amitriptyline, splint therapy, pain reduction |
| Study hypothesis | Patients taking low-dose amitriptyline will have lower pain and improved quality of life compared to those taking active placebo. |
| Ethics approval(s) |
Approved 15/09/2015, Ethics Committee of the University of Zagreb School of Dental Medicine (Petrinjska 34, Zagreb, 10000, Croatia; +385 014802111; dekanat@sfzg.hr), ref: 01-PA-26-6/15 |
| Condition | Orofacial pain due to chronic temporomandibular disorder |
| Intervention | 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 sought. Patients will sign an informed consent to participate. Two researchers will examine the patients using the Croatian version of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The Visual Analogue Scale (VAS) will be used to determine the intensity of pain, and the Oral Health Impact Profile-14 (OHIP-14) will assess the quality of life. Patients will receive either amitriptyline at a dose of 25 mg or a placebo. The medicine and the placebo will be packed in the medicine factory at random with the help of a computer program in identical bottles with numbers. What is in each bottle will be recorded on a list that the researchers will open at the end of the research. The vial each patient receives is also assigned by a computer program. Patients will be followed up at 4 and 8 weeks, and VAS and OHIP-14 will be measured each time. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amitriptilin |
| Primary outcome measure | 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 outcome measures | There are no secondary measures |
| Overall study start date | 15/06/2015 |
| Overall study end date | 19/06/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 40 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 21/09/2015 |
| Recruitment end date | 24/04/2018 |
Locations
Countries of recruitment
- Croatia
Study participating centre
Zagreb
10000
Croatia
Sponsor information
University/education
Faculty of Dentistry in Zagreb, Gundulićeva 5
Zagreb
10 000
Croatia
| Phone | +385-1-4802-111 |
|---|---|
| dekanat@sfzg.hr | |
| Website | https://www.sfzg.unizg.hr/ |
"ROR" |
https://ror.org/00mv6sv71 |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 25/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Datasets generated during the study will be available upon request to the researcher, Ratka Borić Brakus, ratka.boric@gmail.com. Research results obtained from statisticians can be obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/03/2025 | 05/03/2025 | Yes | No |
Editorial Notes
05/03/2025: Publication reference added.
01/10/2024: Study's existence confirmed by the University of Zagreb, Faculty of Dentistry in the Republic of Croatia.
