In Vivo Comparison of Two Different Occlusal Splints in Bruxism

NCT06482060 | Completed

• 1 other identifier: MUDHF_Prosthesis_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

According to the international consensus, bruxism is a masticatory muscle activity consisting of grinding and clenching while sleep or wakefullness. The etiology of bruxism is multifactorial and phisical and psychological facts are some causes of this habit. Bruxism is one of the main causes of tooth wear and temporomandibular joint diseases. Muscle ensembles that occur in bruxist individuals can cause temporomandibular joint degenerations. There is no definitive method recommended for the treatment of sleep bruxism. The most important clinical intervention for sleep bruxism is to protect teeth, reduce teeth grinding, relieve facial and temporal pain and improve sleep quality. Stabilization splint is the gold standard in temporomandibular joint treatments. The purpose of occlusal splint treatment is to improve the functions of tmj and masticatory muscles by creating a balanced , stable occlusion to eliminate the associated pain to reduce the effects of occlusal interferences and parafunctional habits. Conventional occlusal devices have been fabricated from different materials including polyethylene (PVAc-PE), auto-, heat-, and lightpolymerized acrylic resin. However, despite the interesting characteristics of these materials, they are not considered optimal due to potential thermal discomfort, bad taste, residual monomers, dimensional instability, undesirable shape or color, fracture susceptibility, and skin or respiratory allergies of polymethyl mehacrylate (PMMA) resin, in addition to the time-demanding manufacturing process. New digital technologies based on computer-aided design and computer-aided manufacturing have enabled the use of digital workflow in the fabrication of occlusal devices or other intraoral prostheses such as complete dentures and interim fixed restorations, by using subtractive milling or additive approaches. Such devices are manufactured from prefabricated and standard materials such as polycarbonate, polyetheretherketone (PEEK), and PMMA discs. The whole workflow of digital occlusal splints enhances occlusal design and considerably simplifies and optimizes the traditional occlusal splint manufacturing process. Furthermore, digital occlusal splints have shown superior performance over traditional ones in terms of fit, quantitative control, time-saving, speed, and dimensional stability. The aim of this study is to evaluate the patient satisfaction and wear rates of occlusal splint materials that fabricated with conventional and CAD/CAM techniques.

Conditions

Bruxism

Keywords

Bruxism; Stabilization splint; Digital workflow

Outcome Measures

Primary Outcomes (1)

• Change in vertical and volumetric loss of splint material during the treatment

  The occlusal surfaces of the stabilization splints were scanned with the 3Shape Trios 3 scanning device (3Shape Dental Systems, Copenhagen, Denmark) three times for each volunteer as before use scan, 3 month end of use scan and 6 months end of use scan. STL images uploaded to Geomagic Control 2014.4.0 program and vertical an volumetric losses are evaluated.

  At the beginning, 3. months and 6. months

Secondary Outcomes (2)

• Change in pain of the patient with Visual Analog Scale (VAS) during the treatment

  At the beginning, 1. Months and 6. Months

• Change in patient satisfaction during the treatment

  At the beginning, 6. Months

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

Device: Stabilization splint

Digital workflow group

EXPERIMENTAL

Device: Stabilization splint

Interventions

Stabilization splint DEVICE

Stabilization splint application is a treatment that improves the function of TMJ and masticatory muscles by creating a balanced, stable occlusion to reduce the effects of occlusal interference and parafunctional habits and eliminate associated pain.

Conventional group; Digital workflow group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers with natural dentition between the ages of 18-60
• Diagnosed with bruxism

You may not qualify if:

• Pregnancy
• Alcohol or drug addiction
• Having more than one missing tooth in one part of the oral arch

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (4)

• Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013.

  PMID: 11748392 BACKGROUND

• Lobbezoo F, Ahlberg J, Glaros AG, Kato T, Koyano K, Lavigne GJ, de Leeuw R, Manfredini D, Svensson P, Winocur E. Bruxism defined and graded: an international consensus. J Oral Rehabil. 2013 Jan;40(1):2-4. doi: 10.1111/joor.12011. Epub 2012 Nov 4.

  PMID: 23121262 BACKGROUND

• Marcel R, Reinhard H, Andreas K. Accuracy of CAD/CAM-fabricated bite splints: milling vs 3D printing. Clin Oral Investig. 2020 Dec;24(12):4607-4615. doi: 10.1007/s00784-020-03329-x. Epub 2020 May 21.

  PMID: 32436163 BACKGROUND

• Melo G, Duarte J, Pauletto P, Porporatti AL, Stuginski-Barbosa J, Winocur E, Flores-Mir C, De Luca Canto G. Bruxism: An umbrella review of systematic reviews. J Oral Rehabil. 2019 Jul;46(7):666-690. doi: 10.1111/joor.12801. Epub 2019 May 7.

  PMID: 30993738 BACKGROUND

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: May 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

TU (1)