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Clinical Performance of CAD/CAM Splint Materials

NCT05955222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-15

No results posted yet for this study

Summary

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.

Conditions

  • TMD

Interventions

DEVICE

PEEK

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

DEVICE

PMMA

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

DEVICE

Traditional

Participants receiving splints from vacuum forming system

Sponsors & Collaborators

  • Istanbul University

    lead OTHER

Principal Investigators

  • Bilge Gokcen Rohlig, Prof. Dr. · Istanbul University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-02
Primary Completion
2022-08-30
Completion
2023-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05955222 on ClinicalTrials.gov