Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders; Temporomandibular Disorder; Orofacial Pain
• Intervention / Treatment: Other: stabilization splint

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2 mm-thick splint group (2 mm-TSG); The group which applied the 2 mm thick stabilization splint	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
Active Comparator: 4 mm-thick splint group (4 mm-TSG); The group which applied the 4 mm thick stabilization splint	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 closingClicks 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Halenur Bilir, DDS, Medipol University; Study Chair: Hanefi Kurt, PhD, Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 30, 2015

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: temporomandibular disorders; temporomandibular joint; stabilization splint; RDC/TMD; orofacial pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Disease; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain
• Other Study ID Numbers: halenurbilir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No