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Completed

NCT Number: NCT04934449

Occlusal Splints in the Treatment of Sleep Bruxism

Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material.

In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep quality and occlusal force parameters of patients with sleep bruxism.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul university,Faculty of Dentistry

Fatih, 34452, Turkey (Türkiye)

About this study

Various splint designs have been used for the treatment of sleep bruxism that is made up of different materials: Hard and soft splints. Although, these splints have slightly different appearances and properties, in fact, scientific evidence supports both the use of hard and soft occlusal splints. Hard splints are more preferred when compared to soft ones, thus, oft appliances have been less documented in the scientific literature. However, some studies suggested the use of soft-resin splints that are easily fabricated and may be inserted at an initial appointment, dental clinicians may desire the use of soft appliances. One of the advantages of these appliances is they are easy to tolerable to the patient and comfortable. Additionally, these splints fit tightly and provide a flat plane during sleep.

Considering these advantages, the present study was designed to examine the effect of the use of different types of occlusal splints on the sleep quality and occlusal force of patients with sleep bruxism. For this purpose, the effect of two splints basically fabricated from two different materials were evaluated and compared. The null hypothesis was that the use of both occlusal splints would not change the values of sleep quality and maximum occlusal force of the patients with sleep bruxism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy participants with complete permanent dentition.

Exclusion criteria

  • Presence of a systemic disorder that could compromise the masticatory system (e.g., neurological disorders, epilepsy, cerebral palsy, among others),
  • Systemic disorder or current use of drugs that could interfere, directly or indirectly, with muscle activity,
  • Inappropriate behavior and/or refusal to cooperate with dental procedures and data collection,
  • Tooth loss (except for third molars),
  • Soft tissue abnormalities,
  • Toothache report,
  • Active periodontitis (presence of periodontal pockets involvement of the supporting tissues),
  • Caries lesions,
  • Use of orthodontic appliances,
  • Use of dental prosthesis (fixed or removable partial).
  • Subjects with moderate to severe malocclusions, diagnosed by using the Orthodontic Treatment Need Index (IOTN) (scores 5 or 6 - severe and extreme need for orthodontic treatment)
  • Alcohol or drug abuse,

Treatment and study plan

Occlusal splint

Device

Using occlusal splints during sleep for 2 months

Primary outcomes

  1. Sleep quality

    Time frame: 2 months

    Evaluating sleep quality with Pittsburgh sleep quality index

  2. occlusal force

    Time frame: 2 months

    Measuring maximum occlusal force by using digital gnatodynanometer

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

The Effect of Occlusal Splint Type on Sleep Quality and Occlusal Force in Patients With Sleep Bruxism

Acronym: bruxism

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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