Dental Prosthesis FailureNCT05818436
Immediate Dental Prosthesis Functionalization Protocol in People Over 70 Years of Age
A study testing Procedure: prosthetic functioning and Conventional dental prosthesis in people with Dental Prosthesis Failure and Frail Elderly Syndrome, run by University of Chile at 1 site in Chile.
Trial summary
Sarcopenia and malnutrition are closely involved in frailty. To prevent them, it is essential to assess oral function. "Oral fragility" manifests with specific signs or symptoms, including occlusion loss due to tooth loss and chewing difficulty. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Dental Prosthesis Failure, Frail Elderly Syndrome
- What is being tested?
- Procedure: prosthetic functioning and Conventional dental prosthesis
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChile
- Study dates
- 19 Apr 2021to 30 Mar 2024
- 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 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: Impact on General Functionality of an Immediate Prosthetic Functionalization Protocol in People Over 70 Years of Age with Deficient Removable Prostheses
Sarcopenia and malnutrition are closely involved in frailty. To prevent them, it is essential to assess oral function. "Oral fragility" manifests with specific signs or symptoms, including occlusion loss due to tooth loss and chewing difficulty. To recover from it, restoring function by placing a dental prosthesis in the event of tooth loss is essential. In Chile, many patients referred to secondary care to perform new prosthetic treatment live in conditions of less oral functionality and enter waiting lists that can take years, impacting general functionality. Falls are a public health problem with a high economic cost, 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.
General objective: To evaluate the impact on the general functionality of applying 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 receiving 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, Pearson's Correlation will be used; for risk of pre and post-fall, the t-test will be applied for two related samples; for quality of life before and after the 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.
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 speciality 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, which 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, which takes about two months, a period in which they continue with oral hypofunction. This functional pathophysiological condition closely maintains the negative impact on nutrition. Our proposal consists of carrying out a dental intervention, the 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 and recover the prosthetic biomechanical characteristics by improving prosthetic support, retention and stability. This will be made with supplies commonly used in the dental clinic, health services and university teaching clinics. To evaluate this intervention's effect 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. 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 the study, the use of prostheses increased the hand's gripping force by a statistically significant value.
This research aims to contribute to the Chilean population since the immediate recovery of oral functionality may contribute to reducing conditions that increase frailty, which in cases of entering long-term lists is expected to have a more significant impact on 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 adhesive powders to "improve" prosthetic adhesion. With this, it is also possible to contribute to improving the quality of life of these patients due to the recovery of functions: masticatory and social. It will also allow better integration of dentists into the multidisciplinary team in the care model proposed by the Health Ministry. It 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, the 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 to a greater increase in older inhabitants and also the costs already described
- Conditions
- Dental Prosthesis Failure, Frail Elderly Syndrome
- Being tested
- Procedure: prosthetic functioning, Conventional dental prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: prosthetic functioningProcedure or surgery
Prosthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts
Conventional dental prosthesisDevice
: conventional prosthetic treatment new prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Oral Functionalization Prosthesis repairment | Experimental | Experimental: Oral Functionalization 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: Procedure: prosthetic functioning; Device: Conventional dental prosthesis |
| Active Comparator: control | Active comparator | Active Comparator: control conventional prosthetic treatment (new prosthesis) Receives: Device: Conventional dental prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip strength change
measurment in kilograms of handgrip strength. Higher scores mean a better outcome
Measured: Time Frame: Baseline, 15 and 30 days after intervention
Time up-and-go change
Measurement of Timed up-and-go test. Measured in seconds. Higher scores mean worse outcomes
Measured: Time Frame: Baseline, 15 and 30 days after intervention
Estimation of oral health-related Quality of Life change
Use of Oral Health Impact Profile Ultra Short Version (OHIP 7Tsp) survey. Score from 0 to 28, higher scores mean worse outcomes
Measured: Time Frame: Baseline, 15 and 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start19 Apr 2021
- Primary completion30 Oct 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Prosthesis FailureStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile
- Responsible party
- Principal investigator, Pilar Barahona, University of Chile
- Investigators
- Pilar O Barahona, DDS, MSC, Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818436
- Sponsor's protocol ID
- 05595304
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2023
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on General Functionality of an Immediate Prosthetic Functionalization Protocol in People Over 70 Years of Age with Deficient Removable Prostheses
- ClinicalTrials.gov ID
- NCT05818436
- Acronym / sponsor ID
- 05595304
- Conditions
- Dental Prosthesis Failure, Frail Elderly Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- National Fund for Research and Development in Health, Chile
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 18 Apr 2023 (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.
Sarcopenia and malnutrition are closely involved in frailty. To prevent them, it is essential to assess oral function. "Oral fragility" manifests with specific signs or symptoms, including occlusion loss due to tooth loss and chewing difficulty. To recover from it, restoring function by placing a dental prosthesis in the event of tooth loss is essential. In Chile, many patients referred to secondary care to perform new prosthetic treatment live in conditions of less oral functionality and enter waiting lists that can take years, impacting general functionality. Falls are a public health problem with a high economic cost, 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.
General objective: To evaluate the impact on the general functionality of applying 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 receiving 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, Pearson's Correlation will be used; for risk of pre and post-fall, the t-test will be applied for two related samples; for quality of life before and after the 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.
Detailed description
In the public health system, older adults who need new dental prostheses are referred from primary health care to the rehabilitation speciality 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, which 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, which takes about two months, a period in which they continue with oral hypofunction. This functional pathophysiological condition closely maintains the negative impact on nutrition. Our proposal consists of carrying out a dental intervention, the 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 and recover the prosthetic biomechanical characteristics by improving prosthetic support, retention and stability. This will be made with supplies commonly used in the dental clinic, health services and university teaching clinics. To evaluate this intervention's effect 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. 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 the study, the use of prostheses increased the hand's gripping force by a statistically significant value.
This research aims to contribute to the Chilean population since the immediate recovery of oral functionality may contribute to reducing conditions that increase frailty, which in cases of entering long-term lists is expected to have a more significant impact on 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 adhesive powders to "improve" prosthetic adhesion. With this, it is also possible to contribute to improving the quality of life of these patients due to the recovery of functions: masticatory and social. It will also allow better integration of dentists into the multidisciplinary team in the care model proposed by the Health Ministry. It 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, the 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 to a greater increase in older inhabitants and also 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 |
|---|---|---|
| Experimental: Oral Functionalization Prosthesis repairment | Experimental | Procedure: Procedure: prosthetic functioning, Device: Conventional dental prosthesisExperimental: Oral Functionalization Prosthesis repairment: prosthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts and follow up with conventional prosthesis treatment |
| Active Comparator: control | Active comparator | Device: Conventional dental prosthesisActive Comparator: control conventional 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 |
|---|---|---|
| Procedure: prosthetic functioningProsthetic reline and occlusal stabilization through repair of missing pieces and recovery of occlusal contacts | Procedure or surgery | Experimental: Oral Functionalization Prosthesis repairment |
| Conventional dental prosthesis: conventional prosthetic treatment new prosthesis | Device | Active Comparator: control, Experimental: Oral Functionalization Prosthesis repairment |
Primary outcome
Handgrip strength change
Time frame: Time Frame: Baseline, 15 and 30 days after intervention
measurment in kilograms of handgrip strength. Higher scores mean a better outcome
Time up-and-go change
Time frame: Time Frame: Baseline, 15 and 30 days after intervention
Measurement of Timed up-and-go test. Measured in seconds. Higher scores mean worse outcomes
Estimation of oral health-related Quality of Life change
Time frame: Time Frame: Baseline, 15 and 30 days after intervention
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
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 Mar 2025.
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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.
Pilar O Barahona, DDS, MSC study chair
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: prosthetic functioning and Conventional dental prosthesis in people with Dental Prosthesis Failure and Frail Elderly Syndrome, run by University of Chile 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: finished, as of the sponsor's last update on 30 Mar 2025. 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?
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?
Handgrip strength change (time frame: Time Frame: Baseline, 15 and 30 days after intervention). 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 30 Mar 2025.