Jaw, EdentulousNCT05007691
Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)
A study testing Occlusal splint in people with Jaw, Edentulous and Mouth, Edentulous, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
Trial summary
the purpose of this study is to clarify the rationale for the choice of the upper or lower jaw for positioning the occlusal splint Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Jaw, Edentulous, Mouth, Edentulous
- What is being tested?
- Occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteRussia
- Study dates
- 16 Jul 2021to May 2022
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- continuous dentition
- diagnosis (by ICD*-10): K03.0 Excessive attrition of teeth
- diagnosis (by ICD-10): K07.6 Temporomandibular joint disorders
- complaints of nocturnal bruxism
- complaints of discomfort in the area of the chewing muscles
- no history of orthopedic and / or orthodontic treatment
Show all 9Show fewer
- absence of concomitant general somatic pathologies in the stage of decompensation
- no history of psychogenic and psychosomatic disorders
- no history of cancer *ICD - Classification of Diseases
Who cannot join
- refusal of the patient during the clinical trial from further treatment
Trial locations and contacts
1 site in 1 country.
Russia1 site
A.I. Yevdokimov Moscow State University of Medicine and Dentistry
Moscow
About this study
Official title: Single-group, Comparative Biomechanical Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction
the purpose of this study is to clarify the rationale for the choice of the upper or lower jaw for positioning the occlusal splint
Read the detailed description
After being informed about the study and potential risks, all patients are giving written informed consent. Occlusal splints for the upper and lower jaws are made for each of the patients. An assessment is made of the relative values and distribution of chewing forces in two cases:
- "maxillary occlusal splint - lower dentition";
- "mandibular occlusal splint - upper dentition". The obtained values are used in the final elemental analysis of the stress-strain state and the degree of displacement of the dentition in both indicated cases.
- Conditions
- Jaw, Edentulous, Mouth, Edentulous
- Being tested
- Occlusal splint
- Keywords
- Denture, Complete, Technology, Dental, Biomedical and Dental Materials
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal splintDevice
Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal splints | Experimental | In a clinical setting, participants test the closure of the occlusal splint with the antagonistic dentition.
Only one of the two occlusal splints (mandibular splint and maxillary splint) is used at a time. Occlusal splints are applied separately and alternately. Receives: Device: Occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teeth
By means of the final elemental analysis, data on the stress-strain state (in MPa) and the displacement of the splinted teeth (in mm) will be obtained, individually for each patient.
Measured: during one appointment, up to 2 hours
Secondary outcomes (1)
Difference between mandible and maxilla dentition in terms of stress-strain state and magnitude of displacement of the teeth
By means of the final elemental analysis, data on the stress-strain state (in MPa) and the displacement of the teeth (in mm) will be obtained, individually for each patient.
Measured: during one appointment, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start16 Jul 2021
- Primary completion9 Feb 2022
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients are included in a single study group. In a study group, each patient is assessed for both of the same primary treatment. The final results for each of the treatments for each patient are used for further analysis by the finite element method.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moscow State University of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergey Arutyunov, PhD, Study director, A.I. Yevdokimov Moscow State University of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007691
- Sponsor's protocol ID
- Arutyunov-2
- Status last verified
- Jul 2021
- First submitted
- 10 Aug 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in temporomandibular joint disorders. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Request will be evaluated under common conditions by Interuniversity Ethics Committee (A.I. Evdokimov Moscow State University of Medicine and Dentistry)
Publications
Gribov D, Antonik M, Butkov D, Stepanov A, Antonik P, Kharakh Y, Pivovarov A, Arutyunov S. Personalized Biomechanical Analysis of the Mandible Teeth Behavior in the Treatment of Masticatory Muscles Parafunction. J Funct Biomater. 2021 Apr 9;12(2):23. doi: 10.3390/jfb12020023.
PubMed 33918647
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-group, Comparative Biomechanical Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction
- ClinicalTrials.gov ID
- NCT05007691
- Acronym / sponsor ID
- Arutyunov-2
- Conditions
- Jaw, Edentulous, Mouth, Edentulous
- Keywords
- Denture, Complete, Technology, Dental, Biomedical and Dental Materials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Moscow State University of Medicine and DentistryUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 9 Feb 2022 (actual)
- Study completion
- May 2022 (estimated)
- First posted
- 16 Aug 2021 (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.
the purpose of this study is to clarify the rationale for the choice of the upper or lower jaw for positioning the occlusal splint
Detailed description
After being informed about the study and potential risks, all patients are giving written informed consent. Occlusal splints for the upper and lower jaws are made for each of the patients. An assessment is made of the relative values and distribution of chewing forces in two cases:
- "maxillary occlusal splint - lower dentition";
- "mandibular occlusal splint - upper dentition". The obtained values are used in the final elemental analysis of the stress-strain state and the degree of displacement of the dentition in both indicated cases.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients are included in a single study group. In a study group, each patient is assessed for both of the same primary treatment. The final results for each of the treatments for each patient are used for further analysis by the finite element method.
| Arm | Type | Receives |
|---|---|---|
| Occlusal splints | Experimental | Device: Occlusal splintIn a clinical setting, participants test the closure of the occlusal splint with the antagonistic dentition. Only one of the two occlusal splints (mandibular splint and maxillary splint) is used at a time. Occlusal splints are applied separately and alternately. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- continuous dentition
- diagnosis (by ICD*-10): K03.0 Excessive attrition of teeth
- diagnosis (by ICD-10): K07.6 Temporomandibular joint disorders
- complaints of nocturnal bruxism
- complaints of discomfort in the area of the chewing muscles
Key exclusion criteria (1 listed)
- refusal of the patient during the clinical trial from further treatment
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 |
|---|---|---|
| Occlusal splintOcclusal splints are hard, made of polymer biocompatible material using digital additive technology. | Device | Occlusal splints |
Primary outcome
Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teeth
Time frame: during one appointment, up to 2 hours
By means of the final elemental analysis, data on the stress-strain state (in MPa) and the displacement of the splinted teeth (in mm) will be obtained, individually for each patient.
1 secondary outcome
Difference between mandible and maxilla dentition in terms of stress-strain state and magnitude of displacement of the teeth
Time frame: during one appointment, up to 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Background: PubMed 33918647Gribov D, Antonik M, Butkov D, Stepanov A, Antonik P, Kharakh Y, Pivovarov A, Arutyunov S. Personalized Biomechanical Analysis of the Mandible Teeth Behavior in the Treatment of Masticatory Muscles Parafunction. J Funct Biomater. 2021 Apr 9;12(2):23. doi: 10.3390/jfb12020023.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in temporomandibular joint disorders. Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Request will be evaluated under common conditions by Interuniversity Ethics Committee (A.I. Evdokimov Moscow State University of Medicine and Dentistry)
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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.
Sergey Arutyunov, PhD study director
A.I. Yevdokimov Moscow State University of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal splint in people with Jaw, Edentulous and Mouth, Edentulous, run by Moscow State University of Medicine and Dentistry at 1 site in Russia.
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 9 inclusion and 1 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 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between mandible and maxilla of occlusal splints in terms of stress-strain state and magnitude of displacement of the splinted teeth (time frame: during one appointment, up to 2 hours). 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 NCT05007691, which also lists 1 linked publication.
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 18 Apr 2022.