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.
Total final enrolment
96
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
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)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/31493297/ (added 23/11/2020)