Influence of Stabilization Splint Thickness on The Temporomandibular Disorders

NCT04524806 | Completed

• 1 other identifier: halenurbilir
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Disorder; Temporomandibular Joint Disorders; Orofacial Pain

Keywords

stabilization splint; temporomandibular disorders; RDC/TMD; temporomandibular joint; orofacial pain

Outcome Measures

Primary Outcomes (2)

• 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: 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

  Up to 6 months

• Presence of intra-capsular temporomandibular disorders

  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

  Up to 6 months

Secondary Outcomes (2)

• Presence of TMJ sounds

  Up to 6 months

• Limitation of jaw movements

  Up to 6 months

Study Arms (2)

2 mm-thick splint group (2 mm-TSG)

ACTIVE COMPARATOR

The group which applied the 2 mm thick stabilization splint

Other: stabilization splint

4 mm-thick splint group (4 mm-TSG)

ACTIVE COMPARATOR

The group which applied the 4 mm thick stabilization splint

Other: stabilization splint

Interventions

stabilization splint OTHER

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

2 mm-thick splint group (2 mm-TSG); 4 mm-thick splint group (4 mm-TSG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Treated with stabilization splint before
• Partial edentulous patients
• Patients in the axis 3 group according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

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

• Halenur Bilir, DDS

  Medipol University

  STUDY DIRECTOR

• Hanefi Kurt, PhD

  Medipol University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 24, 2020
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 30, 2015
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share