SarcopeniaNCT04606745
Increase of Handgrip Strength After the Use of Removable Partial Dentures.
An observational study of Sarcopenia, run by Comisión Nacional de Investigación Científica y Tecnológica at 1 site in Chile.
Trial summary
A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures? Read more about this study
- Who is it for?
- Ages 80 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2018to 31 Jan 2021
- How long will I take part?
- 18 Months
- 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 80 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Independent octogenarians that consulted in centers of the greater metropolitan area of Santiago, Chile, in search of solving their lack of posterior teeth with dental prostheses
Who may be able to join
- agree to participate by signing the voluntary informed consent form
- qualify according to the Eichner Index in any of the categories that represent the loss of premolars and molars: B3-B4-C1-and C2.
Who cannot join
- not accepting to participate
- cognitive or auditory sensory impairment-
- being dependent in activities of daily living
- belonging to another category of the Eichner Index
Trial locations and contacts
1 site in 1 country.
About this study
A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures?
Read the detailed description
A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures?
- Conditions
- Sarcopenia
- Keywords
- removable partial dentures
- Medical subject headings
- Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
role of use of removable partial dentures (RPD) in handgrip strength in octogenarians
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Oct 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Comisión Nacional de Investigación Científica y Tecnológica
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerardo F Fasce Pineda, MD, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606745
- Sponsor's protocol ID
- HDEN
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increase of Handgrip Strength After the Use of Removable Partial Dentures.
- ClinicalTrials.gov ID
- NCT04606745
- Acronym / sponsor ID
- HDEN
- Conditions
- Sarcopenia
- Keywords
- removable partial dentures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Comisión Nacional de Investigación Científica y TecnológicaOther government
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 28 Oct 2020 (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.
A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures?
Detailed description
A common goal of the health professions is to keep the elderly functional, preventing sarcopenia and frailty. Is there an association between handgrip strength in partially edentulous elderlies after completing their dentition with removable partial dentures?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Independent octogenarians that consulted in centers of the greater metropolitan area of Santiago, Chile, in search of solving their lack of posterior teeth with dental prostheses
Key inclusion criteria (2 listed)
- agree to participate by signing the voluntary informed consent form
- qualify according to the Eichner Index in any of the categories that represent the loss of premolars and molars: B3-B4-C1-and C2.
Key exclusion criteria (4 listed)
- not accepting to participate
- cognitive or auditory sensory impairment-
- being dependent in activities of daily living
- belonging to another category of the Eichner Index
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Handgrip strength
Time frame: 18 months
role of use of removable partial dentures (RPD) in handgrip strength in octogenarians
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Comisión Nacional de Investigación Científica y Tecnológica at 1 site in Chile.
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 4 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 28 Oct 2020. 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 Chile. 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?
Handgrip strength (time frame: 18 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 28 Oct 2020.