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Comparative Evaluation of Gnathological Function With Bruxoff®

Comparative Evaluation of Gnathological Function With Bruxoff® in Edentulous Patients With Immediate Load Full-arch Restorations (Columbus Bridge ProtocolTM) vs Toothed Patients: a Pilot Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06096753
Enrollment
20
Registered
2023-10-24
Start date
2023-11-30
Completion date
2025-06-30
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gnathological Function

Keywords

Bruxism, Immediate-load implants, Columbus Bridge Protocol, Bruxoff, Gnathological function

Brief summary

This study aims to compare the gnathological function of edentulous patient rehabilitated according to the full-arch method (Columbus Bridge Protocol™) with immediate loading with that of dentate patients, through at-home night-time monitoring with Bruxoff® device.

Detailed description

Dental implants are now widely used in dentistry for the rehabilitation of partially or totally edentulous arches. These devices have shown excellent clinical success and are considered a reliable long-term treatment(1). In particular, the rehabilitation of the complete arch with immediate loading supported by maxillary implants has now become a safe and reliable procedure capable of rehabilitating the patient with residual or totally edentulous teeth. A fixed prosthesis supported by implants performed according to an immediate loading protocol represents a valid therapeutic option for the rehabilitation of totally edentulous patients, both from the point of view of patient satisfaction and masticatory performance(2,3,4). 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).

Interventions

DEVICEBruxoff 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.

Sponsors

Prof. Andrea Deregibus
CollaboratorUNKNOWN
Dr. Armando Crupi
CollaboratorUNKNOWN
Dra. Giulia Ambrogio
CollaboratorUNKNOWN
Dr. Andrea Roccuzzo
CollaboratorUNKNOWN
Miss Lisa Sannicolo
CollaboratorUNKNOWN
University of Turin, Italy
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Willingness to participate in the study * 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

(9): * Age \<18 years * 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).

Design outcomes

Primary

MeasureTime frameDescription
Masseter contractionsNight 1, Night 2, Night 3Number and type of masseter contractions (tonic/phasic/mixed)
Bruxism episodesNight 1, Night 2, Night 3Number of possible episodes of nocturnal bruxism in total and per hour of sleep
Heart rateNight 1, Night 2, Night 3Average heart rate

Contacts

Primary ContactFrancesco Pera, Prof.
francesco.pera@unito.it0116331531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026