Comparing the effectiveness of two different treatment methods in treating pain in facial muscles and joints of the jaw

ISRCTN	ISRCTN11790049
DOI	https://doi.org/10.1186/ISRCTN11790049
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	186/2011
Sponsor	Finnish Student Health Service
Funder	Finnish Student Health Service

Submission date: 20/02/2019
Registration date: 21/03/2019
Last edited: 23/11/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Temporomandibular disorders are a series of several different pain symptoms in the face and jaw joints. A common treatment is to manufacture an oral splint to be used when sleeping. This method does not help every patient, so our aim in this trial was to study the effect of a coping method (applied relaxation) compared to the common splint treatment.

Who can participate?
Any student of the age from 19 to 35 and studying in the Finnish Universities of Oulu or Lapland with symptoms of temporomandibular disorders could participate in this one-center trial at the Finnish Student Healthcare System in Oulu, Finland. Persons with a rheumatic disease, fibromyalgia, or suffering from severe mental conditions were excluded as those conditions could interfere with the results.

What does the study involve?
The voluntary participants were divided to two treatment groups receiving either the oral splint treatment or the applied relaxation treatment. They could retire from the trial at any phase without conflict.
A questionnaire of general health and pain items was filled at baseline and at 12-month follow-up. A clinical examination including pain on palpation of the masticatory muscles, pain on moving the jaw, and noises when moving the jaw was performed at baseline, and 3-, 6, and 12-month follow-ups.

What are the possible benefits and risks of participating?
Neither of the treatments give any side effects, and the participants gained in receiving help to their pain symptoms.

Where is the study run from?
The examinations, treatments and analysis of the data was and will be conducted during office hours at the Finnish Student Healthcare System and Universities of Oulu and Eastern Finland by dentist, physiotherapist, and researchers as part of their daily work.

When is the study starting and how long is it expected to run for?
December 2011 to December 2013

Who is funding the study?
Finnish Student Health Service

Who is the main contact?
Outi Huhtela (outi.huhtela@uef.fi)

Contact information

Mrs Outi Huhtela
Scientific

Yliopistonranta 1 C
Kuopio
70210
Finland

ORCID ID	0000-0003-1853-3182
Phone	+358407453688
Email	outi.huhtela@uef.fi

Prof Kirsi Sipilä
Scientific

Aapistie 5
Oulu
90220
Finland

ORCID ID	0000-0001-9734-320X
Phone	+358504423654
Email	kirsi.sipila@oulu.fi

Study information

Primary study design	Interventional
Study design	Single-center longitudinal case-control study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of applied relaxation method vs. splint in treatment of temporomandibular disorders in Finnish students
Study acronym	TMD
Study objectives	Applied relaxation method is as effective as splint treatment in treating temporomandibular disorders of muscular origin
Ethics approval(s)	Approved 03/10/2011, Ethical Committee of the Hospital District of Northern Ostrobothnia, (P.O.Box 8000 FI-90014 University of Oulu, Finland; +358(0)294487001; Janne Kurtakko@oulu.fi), ref: 186/2011
Health condition(s) or problem(s) studied	Signs and symptoms of temporomandibular disorders
Intervention	Applied relaxation method and splint treatment. Patients were randomly assigned by computer-generated random number using SPSS software (version 18.0) into two treatment groups. Applied relaxation is administered by a physiotherapist in six group sessions according to a specified protocol. Splint treatment is applied and checked by a dentist at FSHS. Follow-ups were conducted by a research dentist at 3-, 6- and 12 months from baseline..
Intervention type	Mixed
Primary outcome measure(s)	Symptoms of TMD (pain on palpation; locking of jaws; joint noises) were measured according to the protocol of Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I at baseline, 3,- 6- and 12 month follow-ups.
Key secondary outcome measure(s)	At baseline and at 12-month follow-up: 1. Experienced pain measured by visual analog scale (VAS) 2. Non-specific pain symptoms measured by RDC/TMD (Research Diagnostic Criteria for TMD) Axis II (Finnish version) 3. Depression symptoms measured by RDC/TMD Axis II (Finnish version)
Completion date	22/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	123
Total final enrolment	96
Key inclusion criteria	1. Graduate student at University of Oulu or University of Lapland 2. Age 19 - 35 years 3. Attending Finnish Student Health Service's nurse/doctor/physiotherapist/dentist/dental hygienist appointment complaining of symptoms or signs that could have temporomandibular disorder (TMD) origin 4. No previous diagnosis of muscle or joint-related pain conditions, like fibromyalgia, rheumatic conditions or joint-related psoriasis, or mental disorder 5. Diagnosis of temporomandibular disorder (TMD)
Key exclusion criteria	1. No diagnosis of TMD at baseline examination 2. Diagnosis of muscle or joint-related pain conditions, such as fibromyalgia, rheumatic conditions or joint-related psoriasis 3. Mental disorder
Date of first enrolment	09/12/2011
Date of final enrolment	01/12/2013

Locations

Countries of recruitment

Finland

Study participating centres

University of Oulu

Aapistie 5
Oulu
90220
Finland

Finnish Student Health Service

Yliopistokatu 1 A
Oulu
90570
Finland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository Oulu university , Department of Odontology, https://www.oulu.fi/university/research for 10 years after which it is destroyed

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2020	23/11/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
29/08/2019: Internal review.
21/03/2019: Trial’s existence confirmed by IRB