Condition category
Musculoskeletal Diseases
Date applied
20/02/2019
Date assigned
21/03/2019
Last edited
21/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Outi Huhtela

ORCID ID

http://orcid.org/0000-0003-1853-3182

Contact details

Yliopistonranta 1 C
Kuopio
70210
Finland
+358407453688
outi.huhtela@uef.fi

Type

Scientific

Additional contact

Prof Kirsi Sipilä

ORCID ID

http://orcid.org/0000-0001-9734-320X

Contact details

Aapistie 5
Oulu
90220
Finland
+358504423654
kirsi.sipila@oulu.fi

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

186/2011

Study information

Scientific title

Effectiveness of applied relaxation method vs. splint in treatment of temporomandibular disorders in Finnish students

Acronym

TMD

Study hypothesis

Applied relaxation method is as effective as splint treatment in treating temporomandibular disorders of muscular origin

Ethics approval

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

Study design

Single-center longitudinal case-control study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measure

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.

Secondary outcome measures

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)

Overall trial start date

08/06/2011

Overall trial end date

22/12/2014

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

123 participants at baseline. After randomization and possible exclusion two groups: applied relaxation group 55 participants and splint group 41 participants.

Participant 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

Recruitment start date

09/12/2011

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Finland

Trial participating centre

University of Oulu
Aapistie 5
Oulu
90220
Finland

Trial participating centre

Finnish Student Health Service
Yliopistokatu 1 A
Oulu
90570
Finland

Sponsor information

Organisation

Finnish Student Health Service

Sponsor details

Yliopistokatu 1 A
Kuopio
70100
Finland
+358407453688
outi.huhtela@uef.fi

Sponsor type

Hospital/treatment centre

Website

http://www.yths.fi/en

Funders

Funder type

Hospital/treatment centre

Funder name

Finnish Student Health Service

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in a high-impact peer-reviewed journal
The trial is to be part of a doctoral thesis approximately in August 2020

IPD sharing statement:
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

Intention to publish date

19/06/2019

Participant level data

Stored in repository

Basic results (scientific)

The present study results indicate that applied relaxation (AR) alleviates local temporomandibular disorders (TMD) symptoms comparable to splint treatment. AR more than splint treatment reduces general pain and non-specific pain symptoms and thus defends the idea of tailored treatment. AR is a useful method for TMD patients with multiple pain and psychosocial loading.

Publication list

Publication citations

Additional files

Editorial Notes

21/03/2019: Trial’s existence confirmed by IRB