EdentulousNCT03415971
Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)
A study testing EMG befor denture treatment, EMG in a month after termination of treatment and EMG in a 3 months after termination of treatment in people with Edentulous and Teeth Replacement, run by North-Western State Medical University named after I.I.Mechnikov.
Trial summary
The result of the study will demonstrate that the functional activity of maxillofacial area with edentulous posterior bounded spaces recovers more effectively in patients treated with restorations on implants comparing to patients treated with fixed dentures. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous, Teeth Replacement, Bounded Edentulous Space
- What is being tested?
- EMG befor denture treatment, EMG in a month after termination of treatment and EMG in a 3 months after termination of treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 23 Jan 2018
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Partially edentulous bounded space in dental arch (not more that 3 teeth absent)
- Patients ages 20-45 y.o.
Who cannot join
- Chronical third-degree cardiac failure
- Connective tissue diseases
- Decompensated diabetes
- Neoplastic processes
- Strokes
About this study
The result of the study will demonstrate that the functional activity of maxillofacial area with edentulous posterior bounded spaces recovers more effectively in patients treated with restorations on implants comparing to patients treated with fixed dentures.
Read the detailed description
All patients will be provided with electromyographic research before denture treatment, in a month and three months after the termination of treatment.
- Conditions
- Edentulous, Teeth Replacement, Bounded Edentulous Space
- Being tested
- EMG befor denture treatment, EMG in a month after termination of treatment, EMG in a 3 months after termination of treatment
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG befor denture treatmentProcedure or surgery
Also called electromyographia
EMG in a month after termination of treatmentProcedure or surgery
Also called electromyographia
EMG in a 3 months after termination of treatmentProcedure or surgery
Also called electromyographia
| Study group | Role | What they receive |
|---|---|---|
| ASTRA TECH implants | Active comparator | implant restoration(replace of a missing tooth) - 35 patients Receives: Procedure: EMG befor denture treatment; Procedure: EMG in a month after termination of treatment; Procedure: EMG in a 3 months after termination of treatment |
| CROWN | Active comparator | to fixed denture restorations in own teeth - 32 patients Receives: Procedure: EMG befor denture treatment; Procedure: EMG in a month after termination of treatment; Procedure: EMG in a 3 months after termination of treatment |
| non-edontulos | Placebo comparator | control group will consist 38 non-edotulos patients Receives: Procedure: EMG befor denture treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The signals were averaged over 25 ms, with muscle activity assessed as the root mean square (RMS) of the amplitude (µV). sEMG signals were recorded for further analysis.
The present study demonstrated that Osseo Speed implants are safe and reasonable way of treatment for partial tooth loss in the lateral side. There was observed healthy soft tissue and marginal bone stability around the implants. Received data analysis using surface EMG allow to assume than functional state of maxillofacial region and neuromuscular coordination of the muscles of mastication in patients with bounded edentulous space in the lateral side (molars and/or premolars) with implant-supported prosthesis is considerably better than in patients with fixed bridges. Implant-supported prosthesis provide greater bite force for chewing function in comparison with fixed bridges , but certainly less effective than natural teeth. Implant-supported prosthesis increase patients' quality of life and is more convenient for dentoalveolar apparatus.
Measured: up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study startOct 2015
- Primary completionJan 2016
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- North-Western State Medical University named after I.I.Mechnikov
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silin Alexey Viktorovich, North-Western State Medical University named after I.I.Mechnikov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415971
- Sponsor's protocol ID
- NWSMU
- Status last verified
- Jan 2018
- First submitted
- 28 Jan 2016
- Last updated
- 30 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)
- ClinicalTrials.gov ID
- NCT03415971
- Acronym / sponsor ID
- NWSMU
- Conditions
- Edentulous, Teeth Replacement, Bounded Edentulous Space
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- North-Western State Medical University named after I.I.MechnikovUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 30 Jan 2018 (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 result of the study will demonstrate that the functional activity of maxillofacial area with edentulous posterior bounded spaces recovers more effectively in patients treated with restorations on implants comparing to patients treated with fixed dentures.
Detailed description
All patients will be provided with electromyographic research before denture treatment, in a month and three months after the termination of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASTRA TECH implants | Active comparator | Procedure: EMG befor denture treatment, Procedure: EMG in a month after termination of treatment, Procedure: EMG in a 3 months after termination of treatmentimplant restoration(replace of a missing tooth) - 35 patients |
| CROWN | Active comparator | Procedure: EMG befor denture treatment, Procedure: EMG in a month after termination of treatment, Procedure: EMG in a 3 months after termination of treatmentto fixed denture restorations in own teeth - 32 patients |
| non-edontulos | Placebo comparator | Procedure: EMG befor denture treatmentcontrol group will consist 38 non-edotulos patients |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Partially edentulous bounded space in dental arch (not more that 3 teeth absent)
- Patients ages 20-45 y.o.
Key exclusion criteria (5 listed)
- Chronical third-degree cardiac failure
- Connective tissue diseases
- Decompensated diabetes
- Neoplastic processes
- Strokes
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 |
|---|---|---|
| EMG befor denture treatmentAlso: electromyographia | Procedure or surgery | ASTRA TECH implants, CROWN, non-edontulos |
| EMG in a month after termination of treatmentAlso: electromyographia | Procedure or surgery | ASTRA TECH implants, CROWN |
| EMG in a 3 months after termination of treatmentAlso: electromyographia | Procedure or surgery | ASTRA TECH implants, CROWN |
Primary outcome
The signals were averaged over 25 ms, with muscle activity assessed as the root mean square (RMS) of the amplitude (µV). sEMG signals were recorded for further analysis.
Time frame: up to 3 months.
The present study demonstrated that Osseo Speed implants are safe and reasonable way of treatment for partial tooth loss in the lateral side. There was observed healthy soft tissue and marginal bone stability around the implants. Received data analysis using surface EMG allow to assume than functional state of maxillofacial region and neuromuscular coordination of the muscles of mastication in patients with bounded edentulous space in the lateral side (molars and/or premolars) with implant-supported prosthesis is considerably better than in patients with fixed bridges. Implant-supported prosthesis provide greater bite force for chewing function in comparison with fixed bridges , but certainly less effective than natural teeth. Implant-supported prosthesis increase patients' quality of life and is more convenient for dentoalveolar apparatus.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EMG befor denture treatment, EMG in a month after termination of treatment and EMG in a 3 months after termination of treatment in people with Edentulous and Teeth Replacement, run by North-Western State Medical University named after I.I.Mechnikov.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The signals were averaged over 25 ms, with muscle activity assessed as the root mean square (RMS) of the amplitude (µV). sEMG signals were recorded for further analysis. (time frame: up to 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2018.