Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism
NCT ID: NCT06343194
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
22 participants
INTERVENTIONAL
2025-10-31
2027-12-31
Brief Summary
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The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.
The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.
The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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bruxism patients assessed with Bruxoff ®
Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine, i.e. if they have at least one of the following two points:
1. The subject reports or is aware of noises of grinding or clamping during sleep.
2. One or more of the following signs are present:
* Abnormal wear of teeth;
* Discomfort, fatigue or pain in the muscles of the face;
* Hypertrophy of muscles during voluntary clamping;
* Any abnormalities in the mandibular muscle activity cannot be expressed by other sleep disorders, medical, neurological, drug use or substance abuse;
* Bruxoff ® cut-off more than 4.
Bruxoff ®
Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate.
non-bruxism patients assessed with Bruxoff ®
Subjects with good health, with no evidence of bruxism symptoms or signs. Bruxoff ® cut-off equal or less than 4.
Bruxoff ®
Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate.
Interventions
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Bruxoff ®
Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate.
Eligibility Criteria
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Inclusion Criteria
* Acceptance of informed consent to the study;
* Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine.
* Subjects who don't meet the criteria of sleep bruxism by American Academy of Sleeping Medicine in good health.
Exclusion Criteria
* Medical history of neurological diseases, mental disorders and sleep disturbances e.g. restless leg syndrome and insomnia;
* Patients in therapy with myorelaxants or other medicines that affect chewing muscle activity;
* Patients with pacemakers;
* Patients with periodontal diseases;
* Patients with ongoing orthodontic therapy or with prosthetic rehabilitation
18 Years
45 Years
ALL
Yes
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Massimo Cordaro, professor
Role: PRINCIPAL_INVESTIGATOR
UOC Odontoiatria Generale e Ortodonzia
Locations
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UOC Clinica Odontoiatrica, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore
Rome, Lazio, Italy
Countries
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References
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Lobbezoo F, Naeije M. Bruxism is mainly regulated centrally, not peripherally. J Oral Rehabil. 2001 Dec;28(12):1085-91. doi: 10.1046/j.1365-2842.2001.00839.x.
Ohlmann B, Bomicke W, Behnisch R, Rammelsberg P, Schmitter M. Variability of sleep bruxism-findings from consecutive nights of monitoring. Clin Oral Investig. 2022 Apr;26(4):3459-3466. doi: 10.1007/s00784-021-04314-8. Epub 2021 Dec 3.
Ohlmann B, Rathmann F, Bomicke W, Behnisch R, Rammelsberg P, Schmitter M. Validity of patient self-reports and clinical signs in the assessment of sleep bruxism based on home-recorded electromyographic/electrocardiographic data. J Oral Rehabil. 2022 Jul;49(7):720-728. doi: 10.1111/joor.13327. Epub 2022 Apr 11.
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Miller KB, McGorray SP, Womack R, Quintero JC, Perelmuter M, Gibson J, Dolan TA, Wheeler TT. A comparison of treatment impacts between Invisalign aligner and fixed appliance therapy during the first week of treatment. Am J Orthod Dentofacial Orthop. 2007 Mar;131(3):302.e1-9. doi: 10.1016/j.ajodo.2006.05.031.
Lou T, Tran J, Castroflorio T, Tassi A, Cioffi I. Evaluation of masticatory muscle response to clear aligner therapy using ambulatory electromyographic recording. Am J Orthod Dentofacial Orthop. 2021 Jan;159(1):e25-e33. doi: 10.1016/j.ajodo.2020.08.012. Epub 2020 Nov 21.
Ciavarella D, Fanelli C, Suriano C, Cazzolla AP, Campobasso A, Guida L, Laurenziello M, Illuzzi G, Tepedino M. Occlusal Plane Modification in Clear Aligners Treatment: Three Dimensional Retrospective Longitudinal Study. Dent J (Basel). 2022 Dec 27;11(1):8. doi: 10.3390/dj11010008.
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Other Identifiers
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6162
Identifier Type: -
Identifier Source: org_study_id
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