Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management - RCT

June 16, 2021 updated by: Dalewski Bartosz, Pomeranian Medical University Szczecin

Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management - Randomized, Controlled Clinical Trial

During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy..

Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Patients aged 18-65 years with probable bruxism, yet requiring splint therapy will be included in the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy..

Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Outpatient Clinic of PUM in Szczecin, Poland. Patients aged 18-65 years with probable bruxism, yet requiring splint therapy will be included in the study. Probable bruxism will be diagnosed on the basis of the patient's history and examination as follows. Inclusion criteria:

I. Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).

A. The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.

B. One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.

C. The jaw muscle activity is not better explained by another current sleep disorder, medical or neurological disorder, medication use, or substance use disorder.

II. Additional questionnaire for detecting bruxers:

  1. Has anyone heard you grinding your teeth at night?
  2. Is your jaw ever fatigued or sore in the morning?
  3. Are your teeth or gums ever sore on awakening in the morning?
  4. Do you ever experience temporal headaches on awakening in the morning?
  5. Are you aware of grinding your teeth during the day?
  6. Are you ever aware of clenching your teeth during the day
  7. Can you imitate a sound of grinding using your teeth.

III. Eligible patients will be randomly assigned into two groups. Sealed, opaque envelopes will be used for randomization. The first group will be treated with a stabilization appliance described by Okeson. The second group will undergo therapy with a two-jaw splint with an arch. Patients will be informed about how to use and maintain hygiene of the splint. It will be recommended to use a splint only while sleeping.

IV. Pressure pain threshold test (PPT) will be carried out at the Department of Prosthodontics of the Pomeranian Medical University, Szczecin, Poland using the Wagner Paintest FPX 25 algometer. Points within the following muscles will be examined:

masseter muscles, anterior, middle and posterior abdomens of the temporal muscles, a point at the height of the TMJ larger exterior convexity, the sternocleidomastoid muscles and the preauriculare point, bilaterally two measurements at each visit. The test will be performed at the first visit and after 30 days of therapy.

The algometer comes with a 1 cm2 rubber tip, which measures the pressure in kg / s while pressing on the tested surface. Both test results will be used as a pre- and post- treatment evaluation.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Szczecin, Poland
        • Recruiting
        • Chair and Depratment of Dental Prosthetics
        • Contact:
          • Bartosz Dalewski, DMD, PhD
        • Contact:
          • Kamila Szczuchniak, DMD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • I. Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).

A. The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.

B. One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.

C. The jaw muscle activity is not better explained by another current sleep disorder, medical or neurological disorder, medication use, or substance use disorder.

II. Additional questionnaire for detecting bruxers:

Has anyone heard you grinding your teeth at night? Is your jaw ever fatigued or sore in the morning? Are your teeth or gums ever sore on awakening in the morning? Do you ever experience temporal headaches on awakening in the morning? Are you aware of grinding your teeth during the day? Are you ever aware of clenching your teeth during the day Can you imitate a sound of grinding using your teeth.

Exclusion Criteria:

  • unrestored tooth losses
  • patients wearing removable dentures of any kind
  • psychiatric conditions undermining/preventing occlusal splint usage

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Occlusal appliance by Okeson with canone guidance
Occlusal appliance will be used while sleeping for 30 days.
Device: Two different occlusal splints
Two different occlusal splints will be used for bruxism management, PPT would be evaluated twice - before and after 30 days of splint therapy using pressure algometer (FPX25, Wagner Instruments, US)
ACTIVE_COMPARATOR: Bimaxillary splint without canine guidance
Bimaxillary splint will be used while sleeping for 30 days.
Device: Two different occlusal splints
Two different occlusal splints will be used for bruxism management, PPT would be evaluated twice - before and after 30 days of splint therapy using pressure algometer (FPX25, Wagner Instruments, US)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure pain threshold in designated points
Time Frame: 30 days
Evaluation of difference between algometer readings before and after 30 days of splint usage - FPX25 algometer (Wagner instruments, US) will be used
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Investigators

  • Principal Investigator: Agata Kamińska, DMD, Pomeranian Medical Universiy in Szczecin, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

June 16, 2021

Study Completion (ANTICIPATED)

June 30, 2021

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (ACTUAL)

February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB-0012/49/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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