Increase of Handgrip Strength After the Use of Removable... | NCT04606745

Studies
Increase of Handgrip Strength After the Use of Removable Partial Dentures.

NCT04606745

Sponsor

Comisión Nacional de Investigación Científica y Tecnológica

Status

Unknown status

Last Update Posted

Oct 28, 2020Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Sarcopenia

Interventions

Not provided

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Jan 31, 2021Estimated

First Submitted Date

Oct 22, 2020

First Submission Date that Met QC Criteria

Oct 22, 2020

First Posted Date

Oct 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2020

Last Update Posted Date

Oct 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerardo F Fasce Pineda, MD, MD, University of ChilePrincipal Investigator

Lead Sponsor

Comisión Nacional de Investigación Científica y TecnológicaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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?

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Handgrip strength	role of use of removable partial dentures (RPD) in handgrip strength in octogenarians	18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

not accepting to participate
cognitive or auditory sensory impairment-
being dependent in activities of daily living
belonging to another category of the Eichner Index

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de Chile		Santiago			Chile

Condition Browse Module

MeSH Terms

ID	Term
D055948	Sarcopenia

Ancestor Terms

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided