Gnathological FunctionNCT06096753
Comparative Evaluation of Gnathological Function With Bruxoff®
An observational study of Gnathological Function, run by University of Turin, Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gnathological Function
- What is being tested?
- Bruxoff gnathological function analysis
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The subjects to be included in the study will be chosen from the list of patients rehabilitated according to the immediate-loading full-arch method (Columbus Bridge Protocol™) at the SCDU of Oral Rehabilitation, Maxillofacial Prosthetics and Dental Implantology (University of Turin) (Test Group) and from the list of subjects waiting for implant-prosthetic rehabilitation of intercalated edentulism (i.e. single-tooth implant) (Control Group). The subjects of the Control Group will be matched with a 1:1 ratio for the variables sex and age (±5 years) to the patients of the Test Group. Given the nature of the study (i.e. pilot study), the calculation of the sample size was not possible in the planning phase of the study. However, based on the evidence obtained from similar studies(7), 10 subjects per group are considered sufficient to test this method.
Who may be able to join
- 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%
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Gnathological Function
- Being tested
- Bruxoff gnathological function analysis
- Keywords
- Bruxism, Immediate-load implants, Columbus Bridge Protocol, Bruxoff, Gnathological function
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruxoff gnathological function analysisDevice
The recordings will be carried out for 3 randomly selected nights within 3 weeks, with at least 4 hours of sleep per night.
| Study group | Role | What they receive |
|---|---|---|
| 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®. Receives: Device: Bruxoff gnathological function analysis | |
| 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. Receives: Device: Bruxoff gnathological function analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masseter contractions
Number and type of masseter contractions (tonic/phasic/mixed)
Measured: Night 1, Night 2, Night 3
Bruxism episodes
Number of possible episodes of nocturnal bruxism in total and per hour of sleep
Measured: Night 1, Night 2, Night 3
Heart rate
Average heart rate
Measured: Night 1, Night 2, Night 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Gnathological FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Andrea Deregibus, Dr. Armando Crupi, Dra. Giulia Ambrogio, Dr. Andrea Roccuzzo, Miss Lisa Sannicolo
- Responsible party
- Principal investigator, Francesco Pera, University of Turin, Italy
- Investigators
- Francesco Pera, Prof., Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096753
- Sponsor's protocol ID
- Bruxoff
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30904559Pera 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.
PubMed 30677109Dellepiane 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.
PubMed 33494102Pesce 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.
PubMed 25882620Tealdo 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.
PubMed 21716965Deregibus 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.
PubMed 24374575Castroflorio 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.
PubMed 24417585Saczuk 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.
PubMed 31261634Shimada 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.
PubMed 30716450Lobbezoo 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.
PubMed 29926505Bertazzo-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.
PubMed 27522154Mizumori 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.
PubMed 23626977Farina 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.
PubMed 11686631Berglundh 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.
PubMed 29926491Tonetti 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.
PubMed 29926952
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06096753
- Acronym / sponsor ID
- Bruxoff
- Conditions
- Gnathological Function
- Keywords
- Bruxism, Immediate-load implants, Columbus Bridge Protocol, Bruxoff, Gnathological function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Prof. Andrea Deregibus, Dr. Armando Crupi, Dra. Giulia Ambrogio, Dr. Andrea Roccuzzo, Miss Lisa Sannicolo
- Study start
- Nov 2023 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Device: Bruxoff gnathological function analysisThe 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®. |
| Control Group | – | Device: Bruxoff gnathological function analysisThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The subjects to be included in the study will be chosen from the list of patients rehabilitated according to the immediate-loading full-arch method (Columbus Bridge Protocol™) at the SCDU of Oral Rehabilitation, Maxillofacial Prosthetics and Dental Implantology (University of Turin) (Test Group) and from the list of subjects waiting for implant-prosthetic rehabilitation of intercalated edentulism (i.e. single-tooth implant) (Control Group). The subjects of the Control Group will be matched with a 1:1 ratio for the variables sex and age (±5 years) to the patients of the Test Group. Given the nature of the study (i.e. pilot study), the calculation of the sample size was not possible in the planning phase of the study. However, based on the evidence obtained from similar studies(7), 10 subjects per group are considered sufficient to test this method.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bruxoff gnathological function analysisThe recordings will be carried out for 3 randomly selected nights within 3 weeks, with at least 4 hours of sleep per night. | Device | Control Group, Test Group |
Primary outcome
Masseter contractions
Time frame: Night 1, Night 2, Night 3
Number and type of masseter contractions (tonic/phasic/mixed)
Bruxism episodes
Time frame: Night 1, Night 2, Night 3
Number of possible episodes of nocturnal bruxism in total and per hour of sleep
Heart rate
Time frame: Night 1, Night 2, Night 3
Average heart rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Background: PubMed 30904559Howe 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.
- Background: PubMed 30677109Pera 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.
- Background: PubMed 33494102Dellepiane 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.
- Background: PubMed 25882620Pesce 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.
- Background: PubMed 21716965Tealdo 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.
- Background: PubMed 24374575Deregibus 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.
- Background: PubMed 24417585Castroflorio 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.
- Background: PubMed 31261634Saczuk 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.
- Background: PubMed 30716450Shimada 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.
- Background: PubMed 29926505Lobbezoo 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.
- Background: PubMed 27522154Bertazzo-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.
- Background: PubMed 23626977Mizumori 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Pera, Prof. principal investigator
University of Turin, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Gnathological Function, run by University of Turin, Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pera, Prof. (0116331531, francesco.pera@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseter contractions (time frame: Night 1, Night 2, Night 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06096753, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.