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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04733573
Enrollment
30
Registered
2021-02-02
Start date
2021-01-01
Completion date
2021-06-30
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Sleep Disorder

Keywords

bruxism, algometer, pressure pain threshold, occlusal, splint, grinding, clenching

Brief summary

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.

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.

Interventions

DEVICETwo 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)

Sponsors

Pomeranian Medical University Szczecin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure pain threshold in designated points30 daysEvaluation of difference between algometer readings before and after 30 days of splint usage - FPX25 algometer (Wagner instruments, US) will be used

Countries

Poland

Contacts

Primary ContactBartosz Dalewski, DMD, PhD
bartosz.dalewski@pum.edu.pl0048 914661717
Backup ContactKamila Szczuchniak, DMD
kamila.szczuchniak@gmail.com0048 914661717

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026