Comparative Evaluation of Gnathological Function With Bruxoff®
NCT ID: NCT06096753
Last Updated: 2023-10-24
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
20 participants
OBSERVATIONAL
2023-11-30
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism
NCT06343194
Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis
NCT07053865
Conventional vs Digital CAD/CAM Splints for Bruxism
NCT06518447
Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
NCT03363204
Evaluation of the Impact of Integrating Dynamic Patient-Specific Motion and Implementing a Jaw Tracking System in the Attribution of the Occlusion in Full-Arch Restorations Through a Digital Workflow: a Clinical Study
NCT06773728
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Among the various protocols available in the literature, the one called Columbus Bridge Protocol™, developed by the prosthetic school of the University of Genoa, consists in the rehabilitation of one or both jaws with the insertion of a variable number of 4 to 6 dental implants followed by immediate loading(5). This rehabilitation has been documented to be a reliable implant-prosthetic solution in terms of survival and implant success in the medium and long term(2,6). However, considering the current scientific evidence, there is a lack of information relating to possible alterations in muscle activity following this implant-prosthetic rehabilitation.
For the evaluation of EMG activity of the stomatognathic system, the School of Turin has, for a decade now, tested and validated the use of Bruxoff® portable device for the evaluation of nocturnal bruxism, demonstrating a sensitivity and specificity of 91.6 % and 84.6% respectively (7,8).
Bruxoff® is a portable holter that uses 3 recording channels: 2 for recording the surface electromyographic signals (sEMG) of the two masseter muscles with concentric electrodes positioned on the two muscles (CoDe®: Concentric Detection, Spes Medica, Battipaglia, Italy), and one for heart rate detection (ECG) with a strap incorporating three surface electrodes positioned on the left side of the chest (7,13).
Patients who have been rehabilitated with a full-arch for at least 6 months at the Dental School of Turin and subjects waiting for implant-prosthetic rehabilitation of intercalated edentulism (i.e. single-tooth gap) will be involved.
The recordings will be carried out for 3 randomly selected nights within 3 weeks, with at least 4 hours of sleep per night, according to the method evaluated by Deregibus et al. In particular, the subjects will be instructed to perform 3 maximum voluntary contractions (Maximum Voluntary Clenching, MVC) lasting 2 seconds each and spaced by 5 seconds of rest at the beginning of the recording. The highest measurement among the MVCs is used to normalize the EMG values as a percentage of MVCs. The processing of the data will be carried out automatically and standardized using Bruxmeter software (Bruxmeter®, Spes Medica, Battipaglia, Italy) capable of processing the data recorded from the masseter muscles (surface electromyographic signal) and from the heart (cardiotachymetric signal).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test Group
The Test Group will include patients rehabilitated according to the full-arch method (Columbus Bridge ProtocolTM) with immediate loading for at least 6 months prior to the first nocturnal recording using Bruxoff®.
Bruxoff gnathological function analysis
The recordings will be carried out for 3 randomly selected nights within 3 weeks, with at least 4 hours of sleep per night.
Control Group
The Control Group will include healthy subjects and volunteers awaiting implant-prosthetic rehabilitation of intercalated edentulism (i.e. single-tooth gap) who have natural dentition up to the first molar.
Bruxoff gnathological function analysis
The recordings will be carried out for 3 randomly selected nights within 3 weeks, with at least 4 hours of sleep per night.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bruxoff gnathological function analysis
The recordings will be carried out for 3 randomly selected nights within 3 weeks, with at least 4 hours of sleep per night.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age \>18 years
* M/F sex
* Good general state of health
* Absence of clinical symptoms of bruxism, i.e. sore masticatory muscles(10,11)
* Good level of oral hygiene (assessed with FMPS \<25%)
* FMBS \<25%
Exclusion Criteria
* Presence of severe psychiatric pathologies
* Presence of neuromuscular diseases/ severe neurodegenerative diseases
* Presence of diabetes or other metabolic diseases
* Pharmacological treatment with drugs that compromise the neuromuscular system
* Pharmacological treatment with antipsychotic drugs
* Presence of severe chronic diseases
* Cognitive disability
* Acute inflammation
* Presence of an oncological condition
* Smoking (\>10 cigarettes per day) Individuals with alcohol or drug addiction will be excluded. Subjects will also be asked not to consume caffeine, alcohol and tobacco in the 6 hours before starting the night recording with Bruxoff®(12).
Patients with implants affected by peri-implant pathology will be excluded from the Test Group.(15) Subjects suffering from periodontal disease (Stage III/IV Grade B/C) will be excluded from the Control Group (16).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prof. Andrea Deregibus
UNKNOWN
Dr. Armando Crupi
UNKNOWN
Dra. Giulia Ambrogio
UNKNOWN
Dr. Andrea Roccuzzo
UNKNOWN
Miss Lisa Sannicolo
UNKNOWN
University of Turin, Italy
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francesco Pera
prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Francesco Pera, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Turin, Italy
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Howe MS, Keys W, Richards D. Long-term (10-year) dental implant survival: A systematic review and sensitivity meta-analysis. J Dent. 2019 May;84:9-21. doi: 10.1016/j.jdent.2019.03.008. Epub 2019 Mar 20.
Pera P, Menini M, Pesce P, Bevilacqua M, Pera F, Tealdo T. Immediate Versus Delayed Loading of Dental Implants Supporting Fixed Full-Arch Maxillary Prostheses: A 10-year Follow-up Report. Int J Prosthodont. 2019 Jan/Feb;32(1):27-31. doi: 10.11607/ijp.5804.
Dellepiane E, Pera F, Zunino P, Mugno MG, Pesce P, Menini M. Oral Health-Related Quality of Life and Full-Arch Immediate Loading Rehabilitation: An Evaluation of Preoperative, Intermediate, and Posttreatment Assessments of Patients Using a Modification of the OHIP Questionnaire. J Oral Implantol. 2020 Dec 1;46(6):540-549. doi: 10.1563/aaid-joi-D-19-00274.
Pesce P, Menini M, Furnari M, Pera F, Tealdo T, Pera P. Gastric and masticatory performances in full-arch immediate loading rehabilitated patients. J Oral Rehabil. 2015 Sep;42(9):663-9. doi: 10.1111/joor.12301. Epub 2015 Apr 16.
Tealdo T, Bevilacqua M, Menini M, Pera F, Ravera G, Drago C, Pera P. Immediate versus delayed loading of dental implants in edentulous maxillae: a 36-month prospective study. Int J Prosthodont. 2011 Jul-Aug;24(4):294-302.
Deregibus A, Castroflorio T, Bargellini A, Debernardi C. Reliability of a portable device for the detection of sleep bruxism. Clin Oral Investig. 2014 Nov;18(8):2037-43. doi: 10.1007/s00784-013-1168-z. Epub 2013 Dec 28.
Castroflorio T, Deregibus A, Bargellini A, Debernardi C, Manfredini D. Detection of sleep bruxism: comparison between an electromyographic and electrocardiographic portable holter and polysomnography. J Oral Rehabil. 2014 Mar;41(3):163-9. doi: 10.1111/joor.12131. Epub 2014 Jan 7.
Saczuk K, Lapinska B, Wilmont P, Pawlak L, Lukomska-Szymanska M. The Bruxoff Device as a Screening Method for Sleep Bruxism in Dental Practice. J Clin Med. 2019 Jun 28;8(7):930. doi: 10.3390/jcm8070930.
Shimada A, Castrillon EE, Svensson P. Revisited relationships between probable sleep bruxism and clinical muscle symptoms. J Dent. 2019 Mar;82:85-90. doi: 10.1016/j.jdent.2019.01.013. Epub 2019 Feb 1.
Lobbezoo F, Ahlberg J, Raphael KG, Wetselaar P, Glaros AG, Kato T, Santiago V, Winocur E, De Laat A, De Leeuw R, Koyano K, Lavigne GJ, Svensson P, Manfredini D. International consensus on the assessment of bruxism: Report of a work in progress. J Oral Rehabil. 2018 Nov;45(11):837-844. doi: 10.1111/joor.12663. Epub 2018 Jun 21.
Bertazzo-Silveira E, Kruger CM, Porto De Toledo I, Porporatti AL, Dick B, Flores-Mir C, De Luca Canto G. Association between sleep bruxism and alcohol, caffeine, tobacco, and drug abuse: A systematic review. J Am Dent Assoc. 2016 Nov;147(11):859-866.e4. doi: 10.1016/j.adaj.2016.06.014. Epub 2016 Aug 10.
Mizumori T, Sumiya M, Kobayashi Y, Inano S, Yatani H. Prediction of sleep bruxism events by increased heart rate. Int J Prosthodont. 2013 May-Jun;26(3):239-43. doi: 10.11607/ijp.3305.
Farina D, Cescon C. Concentric-ring electrode systems for noninvasive detection of single motor unit activity. IEEE Trans Biomed Eng. 2001 Nov;48(11):1326-34. doi: 10.1109/10.959328.
Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.
Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Bruxoff
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.