Temporomandibular Disorder Clinical Trial
— TMDOfficial title:
Efficacy of Stabilization Splint Treatment on Facial Pain - One-year Follow-up
NCT number | NCT05240703 |
Other study ID # | 29/2007 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2008 |
Est. completion date | August 31, 2010 |
Verified date | February 2022 |
Source | University of Oulu |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this randomized controlled trial was to assess the efficacy of stabilization splint treatment on TMD-related facial pain and oral health-related quality of life during a one-year follow-up. Eighty TMD patients were randomly assigned to two groups: splint group (n=39) and control group (n=41). The patients in the splint group were treated with a stabilization splint and received counseling and instructions for masticatory muscle exercises. The controls received only counseling and instructions for masticatory muscles exercises. The outcome variables were the intensity of facial pain (as measured with visual analogue scale, VAS), patients' subjective estimate of symptoms and treatment outcome, as well as Oral Heath Impact Profile (OHIP)-14. The differences in variables between the groups at each follow-up points (1 month, 3 months, 6 months and 1 year after baseline) were analyzed using regression models. Group status and presence of psychosocial symptoms were included as the explanatory factor and baseline VAS, gender, age, length of treatment and general health status as confounders.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 31, 2010 |
Est. primary completion date | August 31, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria - clinically diagnosed TMD according to the RDC/TMD - age > 20 years Exclusion Criteria: • Presence of any chronic diseases, such as rheumatoid arthritis, that may affect the TMJ or the masticatory muscles |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Oulu |
Dworkin SF, LeResche L. Research diagnostic criteria for temporomandibular disorders: review, criteria, examinations and specifications, critique. J Craniomandib Disord. 1992 Fall;6(4):301-55. Review. — View Citation
Huttunen J, Qvintus V, Suominen AL, Sipilä K. Role of psychosocial factors on treatment outcome of temporomandibular disorders. Acta Odontol Scand. 2019 Mar;77(2):119-125. doi: 10.1080/00016357.2018.1511057. Epub 2018 Sep 28. — View Citation
Kokkola O, Suominen AL, Qvintus V, Myllykangas R, Lahti S, Tolvanen M, Sipilä K. Efficacy of stabilisation splint treatment on the oral health-related quality of life-A randomised controlled one-year follow-up trial. J Oral Rehabil. 2018 May;45(5):355-362 — View Citation
Qvintus V, Suominen AL, Huttunen J, Raustia A, Ylöstalo P, Sipilä K. Efficacy of stabilisation splint treatment on facial pain - 1-year follow-up. J Oral Rehabil. 2015 Jun;42(6):439-46. doi: 10.1111/joor.12275. Epub 2015 Jan 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in facial pain intensity | The change of the intensity of the facial pain, assessed using Visual Analogue Scale (VAS) on a 0 (no pain) to 10 (pain as bad as could be) rating | from baseline to 1-year follow-up | |
Primary | Subjective estimate on treatment outcome | The patients' subjective estimates of the effects of the treatment were evaluated with a questionnaire, using a scale from 1 to 4 (1= Very good effect, 2= Treatment has helped to some extent, 3= No difference / Cannot tell and 4= Symptoms worsened). | 1 month follow-up | |
Primary | Subjective estimate on treatment outcome | The patients' subjective estimates of the effects of the treatment were evaluated with a questionnaire, using a scale from 1 to 4 (1= Very good effect, 2= Treatment has helped to some extent, 3= No difference / Cannot tell and 4= Symptoms worsened). | 3 month follow-up | |
Primary | Subjective estimate on treatment outcome | The patients' subjective estimates of the effects of the treatment were evaluated with a questionnaire, using a scale from 1 to 4 (1= Very good effect, 2= Treatment has helped to some extent, 3= No difference / Cannot tell and 4= Symptoms worsened). | 6 month follow-up | |
Primary | Subjective estimate on treatment outcome | The patients' subjective estimates of the effects of the treatment were evaluated with a questionnaire, using a scale from 1 to 4 (1= Very good effect, 2= Treatment has helped to some extent, 3= No difference / Cannot tell and 4= Symptoms worsened). | 1 year follow-up | |
Primary | Subjective estimate on symptom severity | The subjective assessment of the severity of TMD symptoms after treatment was assessed by means of a scale on 1 to 5 (1= 'no symptoms'/ 'symptoms not significant', 2 = 'mild symptoms', 3 = 'moderate symptoms', 4 = 'severe symptoms', 5 = 'intolerable symptoms') | 1 month follow-up | |
Primary | Subjective estimate on symptom severity | The subjective assessment of the severity of TMD symptoms after treatment was assessed by means of a scale on 1 to 5 (1= 'no symptoms'/ 'symptoms not significant', 2 = 'mild symptoms', 3 = 'moderate symptoms', 4 = 'severe symptoms', 5 = 'intolerable symptoms') | 3 month follow-up | |
Primary | Subjective estimate on symptom severity | The subjective assessment of the severity of TMD symptoms after treatment was assessed by means of a scale on 1 to 5 (1= 'no symptoms'/ 'symptoms not significant', 2 = 'mild symptoms', 3 = 'moderate symptoms', 4 = 'severe symptoms', 5 = 'intolerable symptoms') | 6 month follow-up | |
Primary | Subjective estimate on symptom severity | The subjective assessment of the severity of TMD symptoms after treatment was assessed by means of a scale on 1 to 5 (1= 'no symptoms'/ 'symptoms not significant', 2 = 'mild symptoms', 3 = 'moderate symptoms', 4 = 'severe symptoms', 5 = 'intolerable symptoms') | 1 year follow-up | |
Primary | Change of Oral health related quality of life (OHRQoL) | Change of Oral health related quality of life was assessed using Oral Health Impact Profile (OHIP-14, sum score from 0 to 56, the higher value indicating poorer OHRQoL) | from baseline to 1-year follow-up |
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