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

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
occlusal stabilization splints
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring equilbration, T scan, Occlusal splints

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

    Exclusion Criteria:

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

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

occlusal stabilization splints equilibrated by articulating paper

occlusal stabilization splints equilibrated by T-scan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Relief of TMD Signs and symptoms
Graded pain scale questionnaire (VAS scale)
Increased range of painless jaw movements
Jaw functional questionnaire (VAS scale)

Secondary Outcome Measures

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

Full Information

First Posted
December 1, 2020
Last Updated
July 27, 2021
Sponsor
Cairo University
Collaborators
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04661670
Brief Title
Occlusal Stabilization Splints Equilibrated by Different Techniques and Their Effect on TMD
Official Title
Relief of Signs and Symptoms in Patients With Tempro-mandibular Disorders Using Occlusal Stabilization Splints Equilibrated by T-scan Versus Articulating Paper: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
February 20, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Eligible patient will be selected from Outpatient Clinic in Prosthodontics Department clinic. Patients will be informed of the nature of the research work and informed consent will be obtained from each of them.All patients will be assessed for TMJ health following DC/TMD Axis I and II to confirm the diagnosis . Base line pain scale and range of pain free jaw movements (mm) will be recorded before starting the treatment. Patients will be randomly divided into 2 equal groups; occlusal stabilization splints equilibrated by articulating paper and occlusal stabilization splints equilibrated by T-scan Patients of both groups will be subjected to: Primary impressions will be taken using rubber base impression material (Zhermac zetaplus impression material) ,the impressions will be poured twice to construct 2 study casts to be used for final occlusal adjustment of the splint. Maxillary Face-bow record will be done to mount both maxillary casts on a semi adjustable articulator (A7-Plus Bio Art semi-adjustable articulator) using different mounting rings. Bite registration using bite registration material (Futar D Bite Registration Material - Ultra Rigid from Kettenbach LP ) will be done in centric relation after deprogramming the muscles using acrylic jig or leaf gauges, followed by loading test for condyle position verification 7to mount the mandibular cast. A protrusive record will be made at 6 mm mandibular protrusion to set the horizontal condylar guidance, while lateral condylar guidance will be adjusted at fixed value of 15 degrees. The centric relation will be verified by comparing the first point of contact intraorally and the first point of contact on the articulator will be verified. The maxillary cast will be surveyed to detect teeth height of contour. The borders of the occlusal splint will be drawn on the maxillary cast to be occlusal to the height of contour buccally and to extend 1-2 mm beyond the gingival margin on the palatal surface. As the jaw relation and mounting will be done by leaf gauges and at elevated vertical dimension, the incisal pin will be kept on zero. The appliance will be waxed up by filling the inter-arch space with pink wax placed will taper it to a feather edge to the previously drawn borders. A complete arch coverage design will be done and will be shaped to be flat. The wax will be checked with 20 um thick articulating paper (AccuFilm, parkell, USA)and should produce bilateral posterior contacts in coincidence with physiologic condylar seating and a smooth anterior guidance in excursions allowing posterior disocclusion2 A mould for the shaped wax will be done using Polyvinyl silicone elastomer putty material (elite P&P, Italy) in a plastic container. A white self-cured acrylic resin (Acrostone cold cure material) will be mixed and filled inside the mould and will be closed tightly till all excess comes out. After material setting the acrylic occlusal splint will be finished and seated on the duplicated cast and final fit and occlusal correction using 20 um thick articulating paper (AccuFilm, parkell, USA) will be done. In the next clinical visit the splint will be inserted inside patient's mouth and will be checked for stability and comfort before any occlusal adjustment which will be performed by articulating paper or T-Scan according to the assigned groups. Study group: In this group the final occlusal correction will be performed with the patient in supine position using 20 um thick articulating paper (AccuFilm, parkell, USA) and articulating foil (DENU shim stock, HDI) 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. Control group: 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. A centric occlusion scan label with Turbo mode (0.003 second incremental scanning) scan speed will be selected. The sensor will be placed intraorally so that the midline 'V' of the support contacts the midline of the occlusal splint. The patient is then asked to gently close on their posterior teeth, then clench firmly against the occlusal splint for one to three seconds. The sensitivity level will be adjusted to fit the patient's occlusal strength. When the sensitivity is properly set, 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. The appropriate excursion scan label will be chosen, after which the patient is asked to clench on their posterior teeth for one to three seconds, and then move in a lateral or protrusive excursion to the full extent of the border movement. Contacts rather than anterior and canine guidance will be eliminated till achieving anterior guidance and posterior disocclusion in time less than 0.5 seconds. For both groups: After occlusal adjustment in centric relation, the occlusion will be evaluated in upright position and will ensure that patient bites comfortably and that all teeth contact evenly, with no anterior teeth contacting harder than the posterior teeth. No polishing will be done after adjustment for maintenance of the refined occlusal contacts. The patients will be instructed to wear the occlusal splint at nighttime, to alleviate daytime harmful habits, the patients will be instructed to seal the lips and separate the teeth, keeping the muscles relaxed. The patients will be recalled every after 1 week and every 2 weeks for further needed occlusal adjustment till there is no change at all between visits After 1 month and 3 months, the patients will be recalled to evaluate the improvements in TMD pain symptoms using questionnaires, in addition to the improvement in range of pain free jaw movements using mm ruler.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
equilbration, T scan, Occlusal splints

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor and statistician will be blinded. It is not possible to blind neither the participant nor the care provider
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
occlusal stabilization splints equilibrated by articulating paper
Arm Type
Active Comparator
Arm Description
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.
Arm Title
occlusal stabilization splints equilibrated by T-scan
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
occlusal stabilization splints
Other Intervention Name(s)
Michigan splint, turner splint
Intervention Description
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
Primary Outcome Measure Information:
Title
Relief of TMD Signs and symptoms
Description
Graded pain scale questionnaire (VAS scale)
Time Frame
3 months
Title
Increased range of painless jaw movements
Description
Jaw functional questionnaire (VAS scale)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
measurement of range of jaw movements (maximum un assisted opening , protruion, right and left excrusion)
Description
ruler measurement
Time Frame
3 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sara Abd el salam, Master
Phone
+201033220667
Email
sara.eman@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid Aziz, PhD
Phone
+201001689901
Email
khaled.Aziz@ngu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf emil, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Khashab, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Abdelsalam, Master

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient1s contact and pre and post data about pain level and jaw movements
IPD Sharing Time Frame
After 2 years
IPD Sharing Access Criteria
a request will be send to me by mail to send the IPD Data
Citations:
PubMed Identifier
24660642
Citation
Kerstein RB, Radke J. Clinician accuracy when subjectively interpreting articulating paper markings. Cranio. 2014 Jan;32(1):13-23. doi: 10.1179/0886963413Z.0000000001.
Results Reference
background
PubMed Identifier
9467991
Citation
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.
Results Reference
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Occlusal Stabilization Splints Equilibrated by Different Techniques and Their Effect on TMD

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