Stabilization Splint Treatment of TMD

NCT05240703 | Completed

• 1 other identifier: 29/2007
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Temporomandibular Disorder; Facial Pain

Keywords

temporomandibular disorders; TMD; facial pain; treatment; stabilization splint; clinical trial

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Stabilization splint group

EXPERIMENTAL

The patients in the splint group were treated with a stabilization splint and received counseling and instructions for masticatory muscle exercises

Device: Stabilization splint treatment

Control group

NO INTERVENTION

The controls received only counseling and instructions for masticatory muscles exercises.

Interventions

Stabilization splint treatment DEVICE

The stabilization splints were made of heat-cured acrylic by the same dental technician. The occlusion of the splint was defined in the centric relation occlusion using wax (Astynax, Associated Dental Products Ltd, UK). The patients were instructed to use the splint every night during the course of the study. The patients were instructed to perform a standardized program for masticatory muscle exercises. At the beginning of the training program, active mouth openings, laterotrusive movements and protrusive movements were performed. The mandible was held in the maximal positions for a few seconds on each movement. Thereafter, these movements were made towards resistance (using the patient's own fingers). After jaw exercises, the patients were suggested to open the jaw wide, stretching it with fingers a few times for 10 to 20 seconds. These movements were repeated 7 to 10 times per training session, and the sessions were performed 2-3 times per day.

Stabilization splint group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinically diagnosed TMD according to the RDC/TMD
• age \> 20 years

You may not qualify if:

• Presence of any chronic diseases, such as rheumatoid arthritis, that may affect the TMJ or the masticatory muscles

Sponsors & Collaborators

• University of Oulu: lead

Related Publications (4)

• 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. No abstract available.

  PMID: 1298767 BACKGROUND

• Huttunen J, Qvintus V, Suominen AL, Sipila 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.

  PMID: 30264631 RESULT

• Kokkola O, Suominen AL, Qvintus V, Myllykangas R, Lahti S, Tolvanen M, Sipila 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. doi: 10.1111/joor.12622.

  PMID: 29512838 RESULT

• Qvintus V, Suominen AL, Huttunen J, Raustia A, Ylostalo P, Sipila 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.

  PMID: 25644634 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirsi Sipilä, Professor

  Research Unit of Oral Health Sciences, University of Oulu, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The same dentist examiner conducted all of the follow-up examinations, being unaware of the group status of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 15, 2022
• Study Start: March 1, 2008
• Primary Completion: August 31, 2010
• Study Completion: August 31, 2010
• Last Updated: February 15, 2022

Record last verified: 2022-02