Occlusal Stabilization Splints Equilibrated by Different Techniques and Their Effect on TMD

NCT04661670 | Unknown DMC

• 1 other identifier: PRO341
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate if occlusal stabilization splints equilibrated by articulating paper will have equivalent effect in comparison to occlusal stabilization splints equilibrated by T-scan regarding the relief of the TMD signs and symptoms

Conditions

Temporomandibular Joint Disorders

Keywords

equilbration; T scan; Occlusal splints

Outcome Measures

Primary Outcomes (2)

• Relief of TMD Signs and symptoms

  Graded pain scale questionnaire (VAS scale)

  3 months

• Increased range of painless jaw movements

  Jaw functional questionnaire (VAS scale)

  3 months

Secondary Outcomes (1)

• measurement of range of jaw movements (maximum un assisted opening , protruion, right and left excrusion)

  3 months

Study Arms (2)

occlusal stabilization splints equilibrated by articulating paper

ACTIVE COMPARATOR

In this group the final occlusal correction will be performed with the patient in supine position using 20 um thick articulating paper and articulating foil 8 um thick. The patient will be asked to tap 3 times on the articulating paper and occlusal correction will be done using carbide laboratory bur and rubber cone till uniform contact on all teeth is achieved in centric relation which is illustrated on the splint by a series of uniformly appearing articulating paper dots. Then the patient will be asked to make protrusive and right and left excursions to ensure smooth anterior guidance and posterior disocclusion.

Device: occlusal stabilization splints

occlusal stabilization splints equilibrated by T-scan

ACTIVE COMPARATOR

In this group the same adjustment sequence will be done using T Scan III (software version 8.0) computerized occlusal analysis, a new patient file will be opened, the patient's biological data will be entered, and the T Scan dental arch size is customized to fit the patients arch anatomy. The patient will be asked to clench to record occlusal force and areas that needs adjustment will be grinded using the paper marks as the guideline and carbide laboratory bur till bilateral force balance achieved and the center of force (COF) icon sits close to the midline. Mandibular excursions are then adjusted in a similar fashion. Contacts rather than anterior and canine guidance will be eliminated till achieving anterior guidance and posterior disocclusion in time less than 0.5 seconds.

Device: occlusal stabilization splints

Interventions

occlusal stabilization splints DEVICE

an intraoral appliance that has flat surface to allow bilateral posterior contacts in coincidence with physiologic condylar seating and to produce smooth anterior guidance in excursions

Also known as: Michigan splint, turner splint

occlusal stabilization splints equilibrated by T-scan; occlusal stabilization splints equilibrated by articulating paper

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult cooperative patients who have bruxism and TMD of myogenous origin (Age: 18-60)
• Fully dentate or partial edentulous patients with no more than one missing tooth per quadrant, excluding third molars
• presence of signs and symptoms of TMD ( diffuse pain in head and neck, headache pain exaggeration by jaw movements, restricted jaw movements)
• severe Disc displacement with or without reduction who can be treated by stabilization appliance (Reciprocal click, or without click)

You may not qualify if:

• Use of removable dentures
• More than one absent tooth per quadrant
• Patients with anterior open bite
• Severe systemic conditions or somatic symptoms, depression and anxiety
• Trauma of recent date towards face, head or neck
• Dentoalveolar pathology or ongoing treatment related to TMD.
• patients scheduled for dental procedures that could alter the occlusion during therapy

Sponsors & Collaborators

• Cairo University: lead
• Ain Shams University: collaborator

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related Publications (2)

• Kerstein RB, Radke J. Clinician accuracy when subjectively interpreting articulating paper markings. Cranio. 2014 Jan;32(1):13-23. doi: 10.1179/0886963413Z.0000000001.

  PMID: 24660642 BACKGROUND

• Garrido Garcia VC, Garcia Cartagena A, Gonzalez Sequeros O. Evaluation of occlusal contacts in maximum intercuspation using the T-Scan system. J Oral Rehabil. 1997 Dec;24(12):899-903. doi: 10.1046/j.1365-2842.1997.00586.x.

  PMID: 9467991 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Ashraf emil, PhD

  Cairo University

  STUDY DIRECTOR

• Mohamed Khashab, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

sara Abd el salam, Master

CONTACT

+201033220667; sara.eman@dentistry.cu.edu.eg

Khalid Aziz, PhD

CONTACT

+201001689901; khaled.Aziz@ngu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor and statistician will be blinded. It is not possible to blind neither the participant nor the care provider
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 10, 2020
• Study Start: May 1, 2021
• Primary Completion: February 20, 2022
• Study Completion: May 30, 2022
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After 2 years
• Access Criteria: a request will be send to me by mail to send the IPD Data

Locations

EG (1)