Clinical Performance of CAD/CAM Splint Materials

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-02

Study Completion Date

2023-04-01

Brief Summary

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The goal of this clinical study is to compare the performance of computer aided designed and computer aided manufactured (CAD/CAM) occlusal splints with splints produced with conventional methods. The main questions this clinical study aims to answer are:

* Do CAD/CAM splints have the same therapeutic effect as the traditional splints ?
* Do CAD/CAM splints demonstrate better surface wear and fit and lower wear in opposing jaw than traditional splints ?
* Is objective pain evaluation of the patient better with CAD/CAM splints ?

Participants were asked to use the splints for 6 months, 8 hours a day and come for follow-up appointments 3 times during this 6 month period:

* Delivery appointment
* First appointment: one week later after delivery appointment
* Last appointment: 6 months after delivery appointment Researchers compared CAD/CAM groups with traditional group to see the clinical performance of the CAD/CAM groups.

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Detailed Description

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24 patients applying to Istanbul University Faculty of Dentistry Department of Prosthodontics and diagnosed with Diagnostic Criteria/ Temporomandibular Disorders (DC/TMD) protocol were included in the study. The patients were randomly divided into 3 groups (n=8); PEEK group (PEEKG), PMMA group (PMMAG), and control group (CG). Dental stone casts of the upper and the lower jaws of the patients were obtained by condensation type silicone impression material and occlusal splints were fabricated in study groups with digital method (designed and milled, manufactured with CAD/CAM) either from PEEK blocks or PMMA blocks and in control group with traditional vacuum pressing machine and adapted by the clinician at chairside. The patients wore the splints for 6 months. Surface roughness, surface wear, fit of the splints and patient satisfaction as well as therapeutic effect of the splints were examined.

Conditions

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TMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is designed as a prospective, randomized, double-blind in-vivo study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patients will not know which group they are assigned. Also the clinician who is going to make the examinations before and after the study will not be aware of groups.

Study Groups

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PEEK splint group

Patients received splints produced from PEEK blocks

Group Type EXPERIMENTAL

PEEK

Intervention Type DEVICE

Participants receiving splints produced with CAD/CAM from PEEK blocks,

PMMA splint group

Patients received splints produced from PMMA blocks

Group Type EXPERIMENTAL

PMMA

Intervention Type DEVICE

Participants receiving splints produced with CAD/CAM from PMMA blocks,

Traditional splint group

Patients received splints produced fabricated traditional methods (vacuum forming )

Group Type ACTIVE_COMPARATOR

Traditional

Intervention Type DEVICE

Participants receiving splints from vacuum forming system

Interventions

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PEEK

Participants receiving splints produced with CAD/CAM from PEEK blocks,

Intervention Type DEVICE

PMMA

Participants receiving splints produced with CAD/CAM from PMMA blocks,

Intervention Type DEVICE

Traditional

Participants receiving splints from vacuum forming system

Intervention Type DEVICE

Other Intervention Names

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bite splints PMMA splints traditional splints

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with TMD according to DC/TMD
* Aged between 18 and 65

Exclusion Criteria

* Patients with removable dentures
* Patients diagnosed with Disc displacement without reduction according to DC/TMD
* Patients receiving medication for psychological disorders
* Patients diagnosed with systemic joint disorders
* Pregnant
* Patients who has received TMD treatment in the last 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No