An interventional study of Professional dental cleaning in Dental Caries of Root Surface and Aging, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Prevention
Keep brushing your teeth, twice a day, during life for healthy teeth and body. Not brushing your teeth regularly and well, may have a devastating effect on your teeth and your general health. The teeth could develop root caries resulting in pain, fractured teeth, tooth loss and trouble eating. Further, brushing your teeth insufficiently leads to higher number of bacteria in the oral cavity and could in frail individuals lead to aspirations pneumonias.
With age, some of us will depend on daily care activities from others and help with daily toothbrushing. However, care dependent older adults often lack basic dental care (tooth brushing with fluoride tooth paste twice a day).
Dental care at home is a service proved by dental personnel. Visits at a dental clinic decrease with age and especially with a dementia diagnosis. Dental care at home can deliver regular dental check-ups and dental treatments to individuals who experience difficulties attending a dental clinic.
The effect of teeth cleaning performed at home on root caries development, has not yet been explored in care dependent older adults. Therefore, the aim is to study if the combination of high fluoride toothpaste used daily with teeth cleaning/ a reminder to use the toothpaste every third month, could be a method for preventing root caries development in this patient group.
The hypothesis is that domiciliary professional cleaning will improve the oral health, as measured by root caries development, gingival bleeding, plaque accumulation and oral mucosal status, compared with a control group that receives oral care as usual.
Care dependent older adults living in nursing homes have high rates of untreated root caries lesions (RCLs). RCLs, if left untreated could lead to pain, tooth loss, difficulties eating, and impacts on general health. An increasing number of research publications point to the association between poor oral health, respiratory tract infections and aspiration pneumonia. Therefore, there is a need for prevention and effective treatment among older adults, and especially those who are care dependent.
When hospitalized or being care dependent, help with care often depends on others. However, nursing assisted oral care/help with oral hygiene, is a difficult task. An effective method for preventing and treating RCLs is to brush the teeth twice a day with high fluoride toothpaste containing 5000 ppm F - . Toothpaste containing 5,000 ppm F - decreases the numbers of RCLs in comparison with ordinary toothpaste containing 1,100 - 1,450 ppm F - .
Visits at a dental clinic decrease with age and especially with a dementia diagnosis. For that reason, the service domiciliary dental care (DDC), could be an option since DDC enables dental care at home (check-ups, prophylaxis, simple tooth extractions, tooth restorations and prothesis adjustments) by dental personnel. DDC could be beneficial for the older adults, due to not having to leave home.
The effect of DDC on root caries development, has not yet been explored in care dependent older adults.
Objectives: The aim is to evaluate the effects of domiciliary professional cleaning for care dependent home living older adults. Furthermore, to contribute to increased knowledge for establishing oral health care recommendations about frequency and content for domiciliary preventive professional oral care in this patient group.
The first hypothesis is that domiciliary professional cleaning will improve the oral health, as measured by; root caries development, gingival bleeding, plaque accumulation and oral mucosal status, compared with a control group that receives assisted oral care as usual.
The second hypothesis is that domiciliary professional cleaning will improve the general health status, as measured by; oral health related quality of life, number of antibiotic treatments and number of respiratory tract infections, compared with a control group that receives assisted oral care as usual.
Study design: The project is designed as a randomized control trial (RCT), evaluator blinded, with two parallel study arms for one year. Randomization will be performed at individual level by a person not otherwise involved in the project.
Data collection will be performed at baseline and at twelve months, by calibrated registered dental hygienists (RDH) assisted by dental assistants. For the intervention, two additional dental assistants, will visit the study participants. Data analysis will be presented at group level and dropouts will be handle according to per protocol analysis.
Description of the study population: Variables regarding cognitive functions by Pfeiffer's test, age, gender, number of respiratory tract infections, oral hygiene habits (frequency of toothbrushing, performing oral hygiene routine by themself or nursing assisted oral care, frequency of interproximal cleaning), dental status (number of teeth, root tips, fillings, dental caries, missing teeth, implants) and drug intake (gathered from responsible nurse) will be collected during baseline visit for descriptive measurements.
The sample size is based on a power calculation (two-tailed) for the primary effect variable root caries, 63 individuals in each group are required. Due to high drop-out rates previously reported in the study population, the sample will be increased by 25%. Accordingly, the number of participants will be n=158 (79 in each group).
Data registration:
The participants are consecutively recruited during their annually oral health assessments and sorted to intervention or control group after informed consent. All study participants will, after baseline, start with fluoridated toothpaste ≥ 4000 part per million (ppm) for brushing their teeth twice a day during the study period to establish an equivalent oral hygiene routine. For controlling the adherence to the toothpaste routine, all participants will receive a litterbox to throw empty toothpaste tubes during the study period.
Preliminary results: The previous study was a RCT - study performed at nursing homes during six months. The intervention group received monthly professional dental cleaning, oral hygiene information and instruction, by RDHs. The control group continued with oral care as usual. Data collection was performed every third month. The analysis showed an improvement in both groups for gingival bleeding, mucosal score and root caries. Due to improvement in both groups, the upcoming study will reduce the prophylactic visits to every third month. Reducing visits is economical beneficial since delivering home care is often more time consuming. Also, instead of having RDHs for the visits, we now engage dental assistants. Dental assistants have prophylactic training in their education and it is important that every profession have possibilities to fully take advantage of their competence.
Significance: Oral diseases and especially dental root caries are common among older adults and increase with age. Among care dependent older adults the amount of untreated root caries is high, causing (if left untreated) pain, tooth loss and impacts on general health. An increasing number of research publications point to the association between poor oral health, aspiration pneumonia and quality of life. For that reason, the need for prevention and effective treatments for root caries is important among older adults, and especially those who need help with daily activities. For prevention, one simple and effective method is to use fluoride toothpaste containing 5000 ppm NaF daily. The combination with this toothpaste and prophylactic/reminding home visits every third month by a dental assistants, could be an effective method for preventing root caries in this patient group.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's enrollment of 194 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Every third month, a dental assistant will visit at home and deliver professional dental cleaning and delivery of one new toothbrush and fluoride toothpaste (\>4000ppm) (n:3) for the next three months. The visit is expected to take at the most 30 minutes.
Other: Professional dental cleaning
Continuous with oral care as usual, either by themselves or nursing assisted (help with oral hygiene procedure) during the whole study period. Home care aides working with the control study participants delivers a toothbrush and fluoride toothpaste (\> 4000 ppm) (n:3) every third month during the study period.
The dental assistant will visit at home and delivers professional dental cleaning, a reminder to use the fluoridated toothpaste (\> 4000 ppm ) and oral hygiene instruction to participants accompanied by home care aides, with manual toothbrush, fluoridated toothpaste (\> 4000 ppm) and relevant interproximal aids.
Dental root caries
Registered by the Fejerskov´s five levels root caries index at baseline and after twelve months.
Time frame: 12 months
Oral health-related quality of life
Measured by Geriatric Oral health Assessment GOHAI at baseline and after twelve months.
Time frame: 12 months
Oral hygiene
Measured by mucosal and plaque index, MPS and will be used both for fixed teeth and removable prosthesis, at baseline and twelve months.
Time frame: 12 months
Gingival bleeding
Bleeding on probing (BoP) in the gingival sulcus on buccal surfaces using the Ramfjord teeth (RT) 16, 21, 24, 36, 41, 44 or the nearest comparable teeth. The bleeding will be scored at four levels (0-3) due to Modified Sulcus Bleeding Index at baseline and after twelve months.
Time frame: 12 months
Oral microbiota
To possibly elucidate the causes behind the oral health situation. Collection of dental plaque and unstimulated saliva samples will be performed single-blinded in a subsample of 50 in the study population at baseline and after twelve months.
Time frame: 12 months
General health
Number of episodes with respiratory tract infections, pneumonia and use of antibiotics. Data is collected from medical responsible nurses at baseline and after twelve months.
Time frame: 12 months
Ran from Dec 2021 to primary completion in Dec 2023, 23 months.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's 23 months is below that.
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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