Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

Not Applicable

Completed

• Conditions: Temporomandibular Disorder; Orofacial Pain; Temporomandibular Joint Disorders
• Interventions: Other: stabilization splint

• Registration Number: NCT04524806
• Lead Sponsor: Istanbul Medipol University Hospital

Brief 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.

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 Timeline

• Study Start: 2013-07-01
• Primary Completion: 2014-01-01
• Study Completion: 2015-01-30
• Status Verified: 2020-08
• Study First Submitted: 2020-08-16
• Study First Submitted QC: 2020-08-20
• Last Update Submitted: 2020-08-20
• Study First Posted: 2020-08-24
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 mm-thick splint group (2 mm-TSG)	stabilization splint	The group which applied the 2 mm thick stabilization splint
4 mm-thick splint group (4 mm-TSG)	stabilization splint	The group which applied the 4 mm thick stabilization splint

Primary Outcome Measures

Name	Time	Method
Presence of intra-capsular temporomandibular disorders	Up to 6 months	II.a Disc displacement with reduction: 1. No pain in the joint; 2. Reproducible (All clicks must be reproduced 2 out of 3 consecutive trials) click on excursion with either opening or closing click; 3. 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: 1. History of locking or catching that interfered with eating; 2. Absence of TMJ clicking; 3. Unassisted opening (even painful) ≤ 35mm and passive stretch ≤ 4mm; 4. Contralateral excursion \< 7mm; II.c Disc displacement without reduction without limited opening: 1. History of locking or catching that interfered with eating; 2. The presence of TMJ sounds excluding DDR clicking; 3. Unassisted opening (even painful) \> 35mm and passive stretch \> 4mm; 4. Contralateral excursion ≥ 7mm
Presence of myofascial pain	Up to 6 months	Myofascial pain and myofascial pain with limited opening are in the Group I according to the RDC/TMD.; I.a Myofascial pain: 1. Reported pain in masticatory muscles (In the jaw, temples, face, preauricular area, or inside the ear, at rest or function); 2. 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: 1. Myofascial pain; 2. Pain-free unassisted 3 opening\< 40 mm and Passive 4 stretch ≥ 5 mm

Secondary Outcome Measures

Name	Time	Method
Presence of TMJ sounds	Up to 6 months	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.
Limitation of jaw movements	Up to 6 months	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.