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Comparative Evaluation of Gnathological Function With Bruxoff®

Sponsor
University of Turin, Italy (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06096753
Collaborator
Prof. Andrea Deregibus (Other), Dr. Armando Crupi (Other), Dra. Giulia Ambrogio (Other), Dr. Andrea Roccuzzo (Other), Miss Lisa Sannicolo (Other)
20
Enrollment
19
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Bruxoff gnathological function analysis

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).

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
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
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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®.

Device: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Masseter contractions [Night 1, Night 2, Night 3]

    Number and type of masseter contractions (tonic/phasic/mixed)

  2. Bruxism episodes [Night 1, Night 2, Night 3]

    Number of possible episodes of nocturnal bruxism in total and per hour of sleep

  3. Heart rate [Night 1, Night 2, Night 3]

    Average heart rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Francesco Pera, Prof., University of Turin, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Francesco Pera, prof., University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT06096753
Other Study ID Numbers:
  • Bruxoff
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 24, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Francesco Pera, prof., University of Turin, Italy
Bruxism
Immediate-load implants
Columbus Bridge Protocol
Bruxoff
Gnathological function

Study Results

No Results Posted as of Oct 24, 2023