Removable Dental ProsthesisPhase 3NCT05595304
Impact on General Functionality of an Immediate Prosthetic Functionalization Protocol in People Over 70 Years of Age With Deficient Removable Prostheses
A Phase 3 study testing prosthetic refunctioning and conventional prosthetic treatment in people with Removable Dental Prosthesis and Dental Restoration, run by Gerardo F Fasce Pineda, MD at 1 site in Chile.
Trial summary
Title: Evaluation of the impact on general functionality of the application of an immediate prosthetic functionalization protocol, in patients with deficient removable prostheses, compared with the conventional treatment that is delivered at the secondary level of the health system, to people over 70 years of age. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Removable Dental Prosthesis, Dental Restoration, Elderly
- What is being tested?
- prosthetic refunctioning and conventional prosthetic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChile
- Study dates
- 3 Nov 2020to 30 May 2023
- Phase
- Phase 3
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 or older
- Willingness to participate
- Discharged from Primary Care to the Oral Health Department at Hospital Salvador, Santiago Chile for prosthetic treatment
- With both maxilar an mandibular prosthesis affected
- Eichner groups B3, B4, C1, C2 and C3.
Who cannot join
- Cognitive impairment (Pfeiffer test classified as moderate or severe)
- Diseases that affect the ability to use facial muscles
- Soft Tissue diseases that affect facial functionality like fibroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact on General Functionality of the Application of a Protocol of Immediate Prosthetic Functionalization in Patients With Deficient Removable Prostheses, Compared With the Conventional Treatment That is Delivery at the Secondary Level of the Health System to People Over 70 Years
Title: Evaluation of the impact on general functionality of the application of an immediate prosthetic functionalization protocol, in patients with deficient removable prostheses, compared with the conventional treatment that is delivered at the secondary level of the health system, to people over 70 years of age.
Introduction: Sarcopenia and malnutrition are closely involved in frailty. To prevent them it is important to assess oral function. "Oral fragility" manifests with specific signs or symptoms, among which are loss of occlusion due to tooth loss and chewing difficulty. To recover from it, it is important to restore function by placing a dental prosthesis in the event of tooth loss. In Chile, a large percentage of patients who are referred to secondary care to perform new prosthetic treatment, lives in conditions of less oral functionality and enters waiting lists that can take years, with a silent impact on general functionality. Falls are a public health problem with a significant economic cost, being the second cause of death worldwide. One of the causes is sarcopenia and it has been studied that the decrease in the number of teeth and the occlusal posterior support region may be risk factors for decreased gait speed, an objective measurement of fall risk. It has been studied that the decrease in the number of teeth causes a reduction in: total muscle mass, walking speed and lower quality of life.
Read more
Hypothesis: The recovery of immediate functionality in deficient prostheses in patients 70 years of age and older will have a positive and rapid impact on general functionality and on their assessment of oral health related quality of life.
General objective: To evaluate the impact on general functionality of the application of an immediate prosthetic functionalization protocol in patients with deficient removable prostheses, compared with conventional treatment, at the secondary level of the health system, in patients over 70 years of age.
Methodology: randomized, double-blind clinical trial with two groups of 62 patients each: experimental and control. The intervention will consist of recovering prosthetic function in one session, before conventional rehabilitation vs. the control group that will receive conventional rehabilitation. Measurements will include manual grip strength measurements, made with a Jamar dynamometer, timed up and go test, before and after prosthetic treatments and quality of life related to oral health through Ohip 7sp. Descriptive statistics will be applied, through the registration of frequency and contingency tables. To compare hand grip strength, the Pearson's Correlation will be used; for risk of pre and post fall, the t-test will be applied for 2 related samples; for quality of life before and after intervention, Chi2 will be used; changes in grip strength, fall risk and quality of life, between the different groups according to the Eichner index, one-way ANOVA will be applied, for related samples.
Results: A short-term improvement is expected in patients whose functionality will be recovered, which, being a simple technique of competence of the general dentist, could be applied in primary care, without loss of valuable time before attention is achieved, at the secondary level for rehabilitation with new prostheses.
Read the detailed description
In the public health system, older adults who need new dental prostheses are referred from primary health care to the rehabilitation specialty at the secondary care level. In many cases, they wear old, fractured, non-functional prosthetic devices and enter waiting lists for several months at the hospital level. During that time, they continue a process of oral hypofunction, a stage that gradually progresses to a process of oral dysfunction and decreased systemic function. Once they are called from the secondary level to enter treatment, they must wait for the rehabilitation process time that takes about two months, a period in which they continue with oral hypofunction, a functional pathophysiological condition that closely maintains the negatively impact in nutrition. Our proposal consists of carrying out a dental intervention, competence of the general dentist, when the patient begins the conventional treatment process, once you enter secondary care. This intervention is intended to immediately recover bilateral, homogeneous and simultaneous occlusal contacts, in addition to recovering the prosthetic biomechanical characteristics, by improving prosthetic support, retention and stability. All of this will be made with supplies commonly used in the dental clinic in health services and university teaching clinics. To evaluate the effect that this intervention will have at the muscular level, the patient's manual grip strength and gait speed will be measured, before the intervention and fifteen days later. Subsequently, once the new prostheses have been made, a new measurement will be made. A quality of life survey related to oral health will be applied to both groups, before and after the intervention and treatment. Based on international scientific evidence and on an investigation carried out by this research team (presented at the Chilean National Congress of Geriatrics and Gerontology), between October 2018 and April 2019 in 60 octogenarian older adults not wearing prostheses in whom dental prostheses were built - whose objective was to determine if there was an association between the use of prostheses that return the premolars and molars and the gripping force of the hand. Hand tightening force was measured before and 15 days after prosthetic rehabilitation with a manual hydraulic dynamometer (Jamar MR). For the cohort in study the use of prostheses increased the gripping force of the hand by a statistically significant value. This research aims to be a contribution for the Chilean population and for geriatrics, since the immediate recovery of oral functionality will eliminate a risk factor in older people, reducing conditions that increase frailty, which in cases of entering long-term lists is expected to have a greater impact at the systemic level and higher health costs. In some cases, out-of-pocket spending on dental supplies will also be reduced, because by recovering prosthetic biomechanical conditions, older people will not have to invest resources in creams and/or adhesive powders to "improve" prosthetic adhesion. With this, it would also be possible to contribute to the improvement of the quality of life of these patients as a result of the recovery of functions: masticatory and social. It will also allow a better integration of dentists into the multidisciplinary team in the care model proposed by the Health Ministry and will allow the development and implementation of a care protocol in primary health care, considering that the intervention will contemplate actions that are the responsibility of general dentists.
Without the development of this research, care system will maintain its long waits for this age group for treatment, a situation that will continue to increase considering that global projections related with a greater increase in older inhabitants, and also of the costs already described.
- Being tested
- prosthetic refunctioning, conventional prosthetic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosthetic refunctioningProcedure or surgery
Active treatment followed by regular interventions
conventional prosthetic treatmentProcedure or surgery
new prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Oral Functionalization | Experimental | Prosthesis repairment: prosthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts and follow up with conventional prosthesis treatment Receives: Procedure: prosthetic refunctioning |
| control | Active comparator | conventional prosthetic treatment (new prosthesis) Receives: Procedure: conventional prosthetic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength
measurment in kilograms of handgrip strength. Higher scores mean a better outcome
Measured: 15-30 days
Falls Risk
Measurement of Time up and go test. Measured in seconds. Higher scores mean worse outcomes
Measured: 15-30 days
Estimation of Quality of Life
Use of Oral Health Impact Profile Ultra Short Version (OHIP 7Tsp) survey. Score from 0 to 28, higher scores mean worse outcomes
Measured: 15-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start3 Nov 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Removable Dental ProsthesisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gerardo F Fasce Pineda, MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gerardo F Fasce Pineda, MD, Comisión Nacional de Investigación Científica y Tecnológica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595304
- Sponsor's protocol ID
- SA20I0052
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact on General Functionality of the Application of a Protocol of Immediate Prosthetic Functionalization in Patients With Deficient Removable Prostheses, Compared With the Conventional Treatment That is Delivery at the Secondary Level of the Health System to People Over 70 Years
- ClinicalTrials.gov ID
- NCT05595304
- Acronym / sponsor ID
- SA20I0052
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Gerardo F Fasce Pineda, MDOther government
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 26 Oct 2022 (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.
Title: Evaluation of the impact on general functionality of the application of an immediate prosthetic functionalization protocol, in patients with deficient removable prostheses, compared with the conventional treatment that is delivered at the secondary level of the health system, to people over 70 years of age.
Introduction: Sarcopenia and malnutrition are closely involved in frailty. To prevent them it is important to assess oral function. "Oral fragility" manifests with specific signs or symptoms, among which are loss of occlusion due to tooth loss and chewing difficulty. To recover from it, it is important to restore function by placing a dental prosthesis in the event of tooth loss. In Chile, a large percentage of patients who are referred to secondary care to perform new prosthetic treatment, lives in conditions of less oral functionality and enters waiting lists that can take years, with a silent impact on general functionality. Falls are a public health problem with a significant economic cost, being the second cause of death worldwide. One of the causes is sarcopenia and it has been studied that the decrease in the number of teeth and the occlusal posterior support region may be risk factors for decreased gait speed, an objective measurement of fall risk. It has been studied that the decrease in the number of teeth causes a reduction in: total muscle mass, walking speed and lower quality of life.
Hypothesis: The recovery of immediate functionality in deficient prostheses in patients 70 years of age and older will have a positive and rapid impact on general functionality and on their assessment of oral health related quality of life.
General objective: To evaluate the impact on general functionality of the application of an immediate prosthetic functionalization protocol in patients with deficient removable prostheses, compared with conventional treatment, at the secondary level of the health system, in patients over 70 years of age.
Methodology: randomized, double-blind clinical trial with two groups of 62 patients each: experimental and control. The intervention will consist of recovering prosthetic function in one session, before conventional rehabilitation vs. the control group that will receive conventional rehabilitation. Measurements will include manual grip strength measurements, made with a Jamar dynamometer, timed up and go test, before and after prosthetic treatments and quality of life related to oral health through Ohip 7sp. Descriptive statistics will be applied, through the registration of frequency and contingency tables. To compare hand grip strength, the Pearson's Correlation will be used; for risk of pre and post fall, the t-test will be applied for 2 related samples; for quality of life before and after intervention, Chi2 will be used; changes in grip strength, fall risk and quality of life, between the different groups according to the Eichner index, one-way ANOVA will be applied, for related samples.
Results: A short-term improvement is expected in patients whose functionality will be recovered, which, being a simple technique of competence of the general dentist, could be applied in primary care, without loss of valuable time before attention is achieved, at the secondary level for rehabilitation with new prostheses.
Detailed description
In the public health system, older adults who need new dental prostheses are referred from primary health care to the rehabilitation specialty at the secondary care level. In many cases, they wear old, fractured, non-functional prosthetic devices and enter waiting lists for several months at the hospital level. During that time, they continue a process of oral hypofunction, a stage that gradually progresses to a process of oral dysfunction and decreased systemic function. Once they are called from the secondary level to enter treatment, they must wait for the rehabilitation process time that takes about two months, a period in which they continue with oral hypofunction, a functional pathophysiological condition that closely maintains the negatively impact in nutrition. Our proposal consists of carrying out a dental intervention, competence of the general dentist, when the patient begins the conventional treatment process, once you enter secondary care. This intervention is intended to immediately recover bilateral, homogeneous and simultaneous occlusal contacts, in addition to recovering the prosthetic biomechanical characteristics, by improving prosthetic support, retention and stability. All of this will be made with supplies commonly used in the dental clinic in health services and university teaching clinics. To evaluate the effect that this intervention will have at the muscular level, the patient's manual grip strength and gait speed will be measured, before the intervention and fifteen days later. Subsequently, once the new prostheses have been made, a new measurement will be made. A quality of life survey related to oral health will be applied to both groups, before and after the intervention and treatment. Based on international scientific evidence and on an investigation carried out by this research team (presented at the Chilean National Congress of Geriatrics and Gerontology), between October 2018 and April 2019 in 60 octogenarian older adults not wearing prostheses in whom dental prostheses were built - whose objective was to determine if there was an association between the use of prostheses that return the premolars and molars and the gripping force of the hand. Hand tightening force was measured before and 15 days after prosthetic rehabilitation with a manual hydraulic dynamometer (Jamar MR). For the cohort in study the use of prostheses increased the gripping force of the hand by a statistically significant value. This research aims to be a contribution for the Chilean population and for geriatrics, since the immediate recovery of oral functionality will eliminate a risk factor in older people, reducing conditions that increase frailty, which in cases of entering long-term lists is expected to have a greater impact at the systemic level and higher health costs. In some cases, out-of-pocket spending on dental supplies will also be reduced, because by recovering prosthetic biomechanical conditions, older people will not have to invest resources in creams and/or adhesive powders to "improve" prosthetic adhesion. With this, it would also be possible to contribute to the improvement of the quality of life of these patients as a result of the recovery of functions: masticatory and social. It will also allow a better integration of dentists into the multidisciplinary team in the care model proposed by the Health Ministry and will allow the development and implementation of a care protocol in primary health care, considering that the intervention will contemplate actions that are the responsibility of general dentists.
Without the development of this research, care system will maintain its long waits for this age group for treatment, a situation that will continue to increase considering that global projections related with a greater increase in older inhabitants, and also of the costs already described.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Functionalization | Experimental | Procedure: prosthetic refunctioningProsthesis repairment: prosthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts and follow up with conventional prosthesis treatment |
| control | Active comparator | Procedure: conventional prosthetic treatmentconventional prosthetic treatment (new prosthesis) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 70 or older
- Willingness to participate
- Discharged from Primary Care to the Oral Health Department at Hospital Salvador, Santiago Chile for prosthetic treatment
- With both maxilar an mandibular prosthesis affected
- Eichner groups B3, B4, C1, C2 and C3.
Key exclusion criteria (3 listed)
- Cognitive impairment (Pfeiffer test classified as moderate or severe)
- Diseases that affect the ability to use facial muscles
- Soft Tissue diseases that affect facial functionality like fibroids
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 |
|---|---|---|
| prosthetic refunctioningActive treatment followed by regular interventions | Procedure or surgery | Oral Functionalization |
| conventional prosthetic treatmentnew prosthesis | Procedure or surgery | control |
Primary outcome
Handgrip strength
Time frame: 15-30 days
measurment in kilograms of handgrip strength. Higher scores mean a better outcome
Falls Risk
Time frame: 15-30 days
Measurement of Time up and go test. Measured in seconds. Higher scores mean worse outcomes
Estimation of Quality of Life
Time frame: 15-30 days
Use of Oral Health Impact Profile Ultra Short Version (OHIP 7Tsp) survey. Score from 0 to 28, higher scores mean worse outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 3 study testing prosthetic refunctioning and conventional prosthetic treatment in people with Removable Dental Prosthesis and Dental Restoration, run by Gerardo F Fasce Pineda, MD 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 5 inclusion and 3 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 26 Oct 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 15-30 days). 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?
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 26 Oct 2022.