Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

Temporomandibular Disorder Clinical Trial

Official title:

Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524806
• Other study ID #: halenurbilir
• Status: Completed
• Phase: N/A
• Start date: July 1, 2013
• Est. completion date: January 30, 2015

Study information

• Verified date: August 2020
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.

Description:

Participants are selected from patients who applied to the clinic with the complaint of temporomandibular disorders (TMDs). Symptoms are evaluated with RDC/TMD forms. Regarding the treatment plan, patients are divided into two groups; 2 mm-thick splint group (2 mm-TSG) and 4 mm-thick splint group (4 mm-TSG). They used SS's at night for 8 hours, and they were recalled on 1st, 2nd, 3rd, and 6th months after splint insertion. Their symptoms and splints are checked.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 30, 2015
• Est. primary completion date: January 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• No need for orthodontic treatment

• Maximum 2 teeth have been extracted

• Having efficient occlusal contacts

• Patients in the axis 1 and axis 2 groups according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

Exclusion Criteria:

• Treated with stabilization splint before

• Partial edentulous patients

• Patients in the axis 3 group according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

Related Conditions & MeSH terms

• Disease
• Facial Pain
• Joint Diseases
• Orofacial Pain
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• stabilization splint
Stabilization splint is an appliance which applied to upper or lower jaw and regulating the occlusal forces in the temporomandibular joint that can cause disorders, also preventing excessive contraction of the masticatory muscles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of myofascial pain	Myofascial pain and myofascial pain with limited opening are in the Group I according to the RDC/TMD.; I.a Myofascial pain: Reported pain in masticatory muscles (In the jaw, temples, face, preauricular area, or inside the ear, at rest or function); Pain on palpation in at least 3 sites (There are 20 sites (ten on each side): posterior, middle and anterior Temporalis; origin, body and insertion of Masseter; posterior mandibular region; Submandibular region; lateral Pterygoid; tendon of Temporalis), one of them at least in the same side of the reported pain; I.b Myofascial pain with limited opening: Myofascial pain; Pain-free unassisted 3 opening< 40 mm and Passive 4 stretch = 5 mm	Up to 6 months
Primary	Presence of intra-capsular temporomandibular disorders	II.a Disc displacement with reduction: No pain in the joint; Reproducible (All clicks must be reproduced 2 out of 3 consecutive trials) click on excursion with either opening or closing click; With click on opening and closing (unless excursive click confirmed): Click on opening occurs at = 5 mm interincisal distance than on closing; Clicks eliminated by protrusive opening; II.b Disc displacement without reduction with limited opening: History of locking or catching that interfered with eating; Absence of TMJ clicking; Unassisted opening (even painful) = 35mm and passive stretch = 4mm; Contralateral excursion < 7mm; II.c Disc displacement without reduction without limited opening: History of locking or catching that interfered with eating; The presence of TMJ sounds excluding DDR clicking; Unassisted opening (even painful) > 35mm and passive stretch > 4mm; Contralateral excursion = 7mm	Up to 6 months
Secondary	Presence of TMJ sounds	Click: A distinct sound, of brief and very limited duration, with a clear beginning and end, which usually sounds like a "click."; Opening Click: If upon opening and closing from maximum intercuspation, a click is noted on two of three opening movements, record as positive for opening click.; Closing Click: A click present on two of three closing mandibular movements.	Up to 6 months
Secondary	Limitation of jaw movements	The researcher places the edge of the millimeter ruler at the incisal edge of the maxillary central incisor that is the most vertically oriented and measures vertically to the labioincisal edge of the opposing mandibular incisor; records this measurement.	Up to 6 months