Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576063
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Antibacterial Photodynamic Therapy As an Adjunctive Treatment on Oral Hygiene in Elderly Persons
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of the Regular Use of Antibacterial Photodynamic Therapy As an Adjunctive Treatment on Oral Hygiene in Elderly Persons Living At Home or At Care Homes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
On average the dental condition of elderly people is poor due to various reasons The importance of oral health maintenance of the ageing population has been recognized by the World Health Organization WHO as oral health plays a key role in reaching the global goal of the Decade of Healthy Ageing 2021-2030
New measures for maintaining good oral health are welcome The use of antibacterial photodynamic therapy aPDT and antibacterial blue light aBL has been studied and found to reduce the amount of plaque in the mouth The Lumoral device is a CE-marked home medical device combining aPDT and aBL and it is effective in reducing the development of plaque and harmful bacteria in the plaque The device has also been shown to be easy and safe to use In this study a combination of regular dental appointments with the importance of enhanced dental self-care will be tested as one regional solution for reaching the global goal set by WHO
New measures for maintaining good oral health are welcome The use of antibacterial photodynamic therapy aPDT and antibacterial blue light aBL has been studied and found to reduce the amount of plaque in the mouth The Lumoral device is a CE-marked home medical device combining aPDT and aBL and it is effective in reducing the development of plaque and harmful bacteria in the plaque The device has also been shown to be easy and safe to use In this study a combination of regular dental appointments with the importance of enhanced dental self-care will be tested as one regional solution for reaching the global goal set by WHO
Detailed Description:
The ageing population is increasing rapidly worldwide In the year 2000 there were 69 million people over the age of 80 in the world and it is estimated that by the year 2030 1 out of 6 persons will be 60 years of age or more worldwide The proportion of the ageing population having their natural teeth left is also increasing In Finland the average number of toothless people aged over 65 has decreased from 44 measured in the year 2000 to 21 in 2011
As people get older their ability to function deteriorates and the elderly especially those living in round-the-clock care have been found to have shortcomings in maintaining oral hygiene Toothlessness is reduced in the elderly population living in care homes too According to a Study in Finland in 2003 52 of inhabitants were toothless in enhanced service housing and in 2017 the proportion of toothless had decreased to 38 In 2017-2018 inhabitants of elderly care homes had an average of 138 teeth Only a small proportion of the population had clean teeth and the worse the level of oral hygiene the worse the quality of life
The World Health Organization has proposed a Decade of Healthy Ageing 2021-2030 action plan to encourage countries to develop and implement policies and programs to promote healthy ageing and improve the quality of life in the older population While there is an interrelation between oral and systemic health periodontal health has been linked to several chronic systemic conditions such as diabetes and cardiovascular diseases via shared inflammatory pathways Good oral health enables daily functions like eating and speaking while tooth loss hyposalivation and other oral conditions obstruct oral functions and make nutritional intake more difficult Bad oral condition also affects social interaction and quality of life As oral functioning declines it is associated with a decline in general function and weakness in the older population and it can eventually lead even to disability and loss of independence Therefore the World Health Organization together with the World Dental Federation have recognized the importance of oral health maintenance and functioning to enable healthy ageing in older adults
The dental condition of elderly persons is often poor Cavities and dental connective tissue disease are relatively common in persons of 75 and older Untreated oral infections predispose elderly people to pneumonia among other complications Chronic oral infectious diseases and sometimes fatal complications are preventable with good oral hygiene Regular cleaning of the mouth and teeth from plaque is still the most important thing for keeping the mouth healthy One third of the aged population in Finland suffers from dry mouth due to various illnesses or the use of many medications Lack or reduction of saliva may predispose to inflammatory diseases in the mouth If multiple medications are in use simultaneously the dry mouth symptoms may even worsen
The use of antibacterial photodynamic therapy aPDT and antibacterial blue light as adjunctive treatments to standard oral home care has been studied and found to reduce the amount of plaque in the mouth The Lumoral device is a CE class IIa -marked medical device for home use that has been found to be effective in reducing the development of plaque and harmful bacteria in the plaque The performance of the device is based on the aPDT method in which the photosensitive substance in the Lumorinse mouthwash attaches to the bacterial coating and is activated as an antibacterial by light The antibacterial effect is applied directly to the plaque reducing the impact on the normal oral flora Preliminary studies have found that the method reduces inflammatory factors in periodontitis In addition the heat produced by the device also enhances saliva production which also affects maintaining good oral health Unpublished data from a randomized clinical trial conducted by the University of Helsinki in which Lumoral was used by the residents of elderly 24-hour care also showed that the device was safe to use and it had a significant impact on oral health measured by the Community Periodontal Index
This study aims to determine the effectiveness of the Lumoral Treatment method as an adjunctive treatment on oral hygiene inflammatory load and dryness of mouth in elderly people living at home or at care homes and who are regular customers with the study sites
As people get older their ability to function deteriorates and the elderly especially those living in round-the-clock care have been found to have shortcomings in maintaining oral hygiene Toothlessness is reduced in the elderly population living in care homes too According to a Study in Finland in 2003 52 of inhabitants were toothless in enhanced service housing and in 2017 the proportion of toothless had decreased to 38 In 2017-2018 inhabitants of elderly care homes had an average of 138 teeth Only a small proportion of the population had clean teeth and the worse the level of oral hygiene the worse the quality of life
The World Health Organization has proposed a Decade of Healthy Ageing 2021-2030 action plan to encourage countries to develop and implement policies and programs to promote healthy ageing and improve the quality of life in the older population While there is an interrelation between oral and systemic health periodontal health has been linked to several chronic systemic conditions such as diabetes and cardiovascular diseases via shared inflammatory pathways Good oral health enables daily functions like eating and speaking while tooth loss hyposalivation and other oral conditions obstruct oral functions and make nutritional intake more difficult Bad oral condition also affects social interaction and quality of life As oral functioning declines it is associated with a decline in general function and weakness in the older population and it can eventually lead even to disability and loss of independence Therefore the World Health Organization together with the World Dental Federation have recognized the importance of oral health maintenance and functioning to enable healthy ageing in older adults
The dental condition of elderly persons is often poor Cavities and dental connective tissue disease are relatively common in persons of 75 and older Untreated oral infections predispose elderly people to pneumonia among other complications Chronic oral infectious diseases and sometimes fatal complications are preventable with good oral hygiene Regular cleaning of the mouth and teeth from plaque is still the most important thing for keeping the mouth healthy One third of the aged population in Finland suffers from dry mouth due to various illnesses or the use of many medications Lack or reduction of saliva may predispose to inflammatory diseases in the mouth If multiple medications are in use simultaneously the dry mouth symptoms may even worsen
The use of antibacterial photodynamic therapy aPDT and antibacterial blue light as adjunctive treatments to standard oral home care has been studied and found to reduce the amount of plaque in the mouth The Lumoral device is a CE class IIa -marked medical device for home use that has been found to be effective in reducing the development of plaque and harmful bacteria in the plaque The performance of the device is based on the aPDT method in which the photosensitive substance in the Lumorinse mouthwash attaches to the bacterial coating and is activated as an antibacterial by light The antibacterial effect is applied directly to the plaque reducing the impact on the normal oral flora Preliminary studies have found that the method reduces inflammatory factors in periodontitis In addition the heat produced by the device also enhances saliva production which also affects maintaining good oral health Unpublished data from a randomized clinical trial conducted by the University of Helsinki in which Lumoral was used by the residents of elderly 24-hour care also showed that the device was safe to use and it had a significant impact on oral health measured by the Community Periodontal Index
This study aims to determine the effectiveness of the Lumoral Treatment method as an adjunctive treatment on oral hygiene inflammatory load and dryness of mouth in elderly people living at home or at care homes and who are regular customers with the study sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None