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Bruxism clinical trials

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NCT ID: NCT02870543 Active, not recruiting - Nocturnal Bruxism Clinical Trials

Efficacy of Phytolacca Decandra and Melissa Officinalis in Children With Nocturnal Bruxism

Start date: September 2014
Phase: Phase 3
Study type: Interventional

This study aims to evaluate, through a crossover, controlled, double-blind and randomized clinical trial, the efficacy of Phytolacca decandra in association or not with Melissa officinalis in the treatment of children with nocturnal bruxism. Children from 3 to 12 years old with nocturnal bruxism will be randomly allocated into different groups of treatment stage as follows: (1) placebo; (2) Phytolacca decandra; (3) Melissa officinalis; (4) Phytolacca decandra associated with Melissa officinalis. All children will participate to each clinical stage, with a period of 14 days of whashout. Children and the principal investigator will be masked to treatment. The efficacy will be evaluated through parents report about the absence of tooth clenching or grinding by children and electromiography exams. The secondary outcomes that will be evaluated are: trait anxiety and quality of life related to oral health.

NCT ID: NCT02757261 Not yet recruiting - Sleep Bruxism Clinical Trials

Evaluation of Muscle Activity, Bite Force and Salivary Cortisol in Children With Bruxism

Bruxism
Start date: June 2016
Phase: Phase 0
Study type: Interventional

Bruxism is a repetitive activity of the masticatory muscles characterized by grinding and/or clenching one's teeth or parafunctional movements of the mandible. The aim of the proposed controlled clinical trial is to evaluate muscle activity, bite force and salivary cortisol in children aged six to eight years with bruxism. The children will be randomly allocated to four groups, each with 19 participants: Group 1 will receive low-level laser therapy at acupuncture points; Group 2 will use an occlusal splint; Group 3 will receive placebo laser therapy; and Group 4 will be the control group without bruxism. Low-level laser (786.94 nm, 0.04 cm2, 70 mW and 20 s per points) will be applied directly on the skin at six acupuncture points on each side. The BTS TMJOINT electromyograph will be used to determine muscle activity and a digital gnathodynamometer will be used to measure bite force. Two saliva collections will be performed in the participant's home at 9 am and prior to going to sleep, with at least one hour of fasting and followed by oral hygiene with water. Evaluations will be performed before as well as one and six months after treatment. The findings will be computed and submitted to statistical analysis. Descriptive statistics will be used first for the determination of point estimates, precision and validation using analysis of variance (ANOVA) for the evaluation of residuals and parametric tests will be used for the determination of pre-treatment conditions. Interval estimates will be used for the variables of interest to determine the prevision of the estimates and perform comparisons. When necessary, transformation methods or non-parametric tests will be used in the data analysis. The chi-square test, Student's t-test and ANOVA will be employed, with the level of significance set at 5% (p < 0.05).

NCT ID: NCT02446288 Not yet recruiting - Bruxism Clinical Trials

TMJ NextGen Pilot Study to Treat Subjects With Bruxism

Start date: June 2015
Phase: N/A
Study type: Interventional

The study is an open-label, prospective, multicenter, randomized, two treatment parallel, comparison study of the TMJ NextGeneration and DSG Relaxer in the reduction of nocturnal bruxism episodes in subjects diagnosed with sleep bruxism.

NCT ID: NCT02410681 Completed - Sleep Bruxism Clinical Trials

Sleep Bruxism and (Peri-)Implant Complications

Start date: March 2015
Phase:
Study type: Observational

Excessive mechanical forces can cause complications of dental implants and their suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft tissues around the implants. Sleep bruxism (grinding and clenching of the teeth during sleep) is considered as an important source of mechanical forces in the oral environment. Therefore, in this study, the investigators will investigate whether sleep bruxism is associated with implant and peri-implant complications.

NCT ID: NCT02340663 Completed - Tooth Wear Clinical Trials

Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV

SISU-SOVA
Start date: November 2015
Phase: N/A
Study type: Interventional

Clinical trials of bite splint use and night time tooth grinding have not been performed. Consequently, there are no definitive outcome measures or efficacy standards that can be applied to large clinical trials. The present preliminary trial will determine what objective measures can be used to evaluate efficacy. The outcome variables will fall into four categories: (1) fabrication efficacy, (2) compliance, (3) functional efficacy, and (4) user satisfaction. The immediate goals will: (1) focus on the over-the counter SOVA night guard, (2) conduct tests under controlled clinical conditions using the 'gold standard', the acrylic 'bite splint' or 'orthotic', hereafter called the "Michigan bite splint", to compare the performance and efficacy of the SOVA night guard. Subsequent studies will be able to use the outcome variables identified in this study for broader clinical trials. Specific Aim 1. To compare the SOVA night guard to the custom-acrylic Michigan bite splint in clinical laboratory conditions. Hypothesis: There will be no significant differences between the devices in terms of fabrication efficacy, functional efficacy or user satisfaction. Specific Aim 2. To compare the SOVA night guard to the custom-acrylic Michigan bite splint under ecologically relevant conditions, i.e., the home environment. Hypothesis: There will be no significant differences between the devices in terms of compliance or functional efficacy.

NCT ID: NCT02269553 Withdrawn - Bruxism Clinical Trials

TMJ-1001 Bruxism Run-In/Pivotal Trial

Start date: April 2015
Phase: N/A
Study type: Interventional

The study is an open-label, prospective, multi-center, randomized, two treatment parallel, comparison study of the TMJ NextGeneration(TM) and custom-fit occlusal splint in the reduction of nocturnal bruxism episodes and monthly migraine episodes in subjects diagnosed with sleep bruxism and headaches.

NCT ID: NCT02257320 Completed - Bruxism Clinical Trials

TMJ NextGeneration(TM) Feasibility Study

Bruxoff
Start date: November 2014
Phase: N/A
Study type: Interventional

The study is an open-label, prospective, single-center, non-randomized feasibility study of the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events and incidence of migraines and headache in subjects diagnosed with sleep bruxism.

NCT ID: NCT02235220 Enrolling by invitation - Bruxism Clinical Trials

Reduction of Masticatory Muscle Activity by Restoring Canine Guidance

Start date: September 2014
Phase: N/A
Study type: Interventional

In this study it is to be evaluated wether a restoration with composite resin fillings to reestablish a canine guidance will reduce masticatory muscle activity in patients with bruxism.

NCT ID: NCT02202070 Withdrawn - Clinical trials for Temporomandibular Joint Disorders

Botox for Treatment of TMJ Disorder With Bruxism

TMJ
Start date: January 2015
Phase: Phase 1
Study type: Interventional

Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up. The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism. By the time patients reach the specialists office, most have failed maximal conservative therapies, including non-chew diet, night guard, oral analgesics, muscle relaxants, physical therapy, and a portion have even undergone more invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty surgeries with limited improvement or recurrence. Primary outcome of the study will be 50% reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase in maximal inter-incisal opening (MIO). The investigators look forward to working with you on the proposed study

NCT ID: NCT01812850 Not yet recruiting - Bruxism Clinical Trials

Effects of the Continuous Wear of Invisalign® Trays on the Temporomandibular Joints and Orofacial Muscular Complex

Start date: April 2013
Phase: N/A
Study type: Observational

The purpose of this study is to assess temporomandibular joint (TMJ) symptoms and night muscle activity in an objective manner, in addition to daytime bruxism and clenching, as reported by the patient, following the start of orthodontic treatment with Invisalign®. A baseline evaluation of all measures will be used as control data, while different time points will be used to evaluate the evolution of patients' symptoms over the course of six months (the duration of the study).