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Dental Caries of Root SurfaceHETNCT05335239

Domiciliary Professional Oral Care for Dependent Older Adults

A study testing Professional dental cleaning in people with Dental Caries of Root Surface and Aging, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dental Caries of Root Surface, Aging
What is being tested?
Professional dental cleaning
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteSweden
Study dates
6 Dec 2021to 4 Apr 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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Home-living older adults
  • Age ≥65
  • Eligible for subsidized dental care for those with in-home care
  • Accepted oral health assessment by dental hygienists
  • Non-smokers
  • Ability to cooperate during oral assessment for 5-10 minutes
Show all 9Show fewer
  • At least one natural tooth
  • Understand and able to communicate in Swedish.
  • Additionally: For oral microbiota, grade 1-2 according to mirror slide friction test.

Who cannot join

  • Edentulousness
  • Full dentures
  • Cognitive limitations that is an obstacle for cooperation
  • Malignancies and/or immunosuppressive diseases
  • Coagulation defects.
  • Anticoagulants are registered but not as an exclusion criterion.
  • Moving or planned to move to a nursing home
  • For oral microbiota: grade 3 according to mirror slide friction test

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska institute

    Huddinge, 114 41

Other trials in Sweden

About this study

Official title: Domiciliary Professional Cleaning for Care Dependent Older Adults - A Randomized Controlled Trial

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).

Read more

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.

Read the detailed description

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:

  • Dental root caries lesions
  • Gingival bleeding/Bleeding on probing (BoP)
  • Oral hygiene
  • Oral health related quality of life
  • General health
  • Oral microbiota: Collection of dental plaque and unstimulated saliva samples will be performed single-blinded in a subsample of 50 from the total study population. To possibly elucidate the causes behind the oral health situation. The PhD-student is responsible for coding, adequate storage and the transport to the lab for analysis. Analysis of saliva samples will be performed at NGS at the appropriate core facilities (SciLifeLabs) at Karolinska Institutet (Professor Belibasakis). Dental plaque at Umeå University, Institute of Odontology, Clinical Oral Microbiology Laboratory (Dr. Anders Johansson). All samples will, after completion of the process at the lab (up to six months after collection), be destroyed.

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.

Being tested
Professional dental cleaning
Keywords
Dental prophylaxis, Aged, Dental devices, Home Care, Root Caries, Sodium Fluoride
Medical subject headings
Root Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Professional dental cleaningOther

    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.

Study groups in NCT05335239
Study groupRoleWhat they receive
Intervention groupExperimentalEvery 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.
Receives: Other: Professional dental cleaning
Controll groupNo interventionContinuous 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dental root caries

    Registered by the Fejerskov´s five levels root caries index at baseline and after twelve months.

    Measured: 12 months

Secondary outcomes (5)
  1. Oral health-related quality of life

    Measured by Geriatric Oral health Assessment GOHAI at baseline and after twelve months.

    Measured: 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2022
  2. Study start6 Dec 2021
  3. Primary completion1 Dec 2023
  4. Study completion4 Apr 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05335239
Sponsor's protocol ID
KarolinskaDalarnaGävleborg
Acronym
HET
Status last verified
Jun 2023
First submitted
12 Apr 2022
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Girestam Croonquist C, Dalum J, Skott P, Sjogren P, Wardh I, Moren E. Effects of Domiciliary Professional Oral Care for Care-Dependent Elderly in Nursing Homes - Oral Hygiene, Gingival Bleeding, Root Caries and Nursing Staff's Oral Health Knowledge and Attitudes. Clin Interv Aging. 2020 Aug 6;15:1305-1315. doi: 10.2147/CIA.S236460. eCollection 2020.

    PubMed 32982191

Questions about this trial

What is this clinical trial studying?

A study testing Professional dental cleaning in people with Dental Caries of Root Surface and Aging, run by Karolinska Institutet at 1 site in Sweden.

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 9 inclusion and 8 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 3 Dec 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 Sweden. 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?

Dental root caries (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05335239, which also lists 1 linked publication.

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 3 Dec 2025.

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