NCT05335239

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
Last Updated

December 3, 2025

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

April 12, 2022

Last Update Submit

November 25, 2025

Conditions

Keywords

Dental prophylaxisAgedDental devices, Home CareRoot CariesSodium Fluoride

Outcome Measures

Primary Outcomes (1)

  • Dental root caries

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

    12 months

Secondary Outcomes (5)

  • Oral health-related quality of life

    12 months

  • Oral hygiene

    12 months

  • Gingival bleeding

    12 months

  • Oral microbiota

    12 months

  • General health

    12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Controll group

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • Edentulousness
  • Full dentures
  • Cognitive limitations that is an obstacle for cooperation
  • Malignancies and/or immunosuppressive diseases
  • Coagulation defects.
  • Moving or planned to move to a nursing home
  • For oral microbiota: grade 3 according to mirror slide friction test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institute

Huddinge, 114 41, Sweden

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental CariesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Inger Wårdh

    Karolinska Institutet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single - blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 19, 2022

Study Start

December 6, 2021

Primary Completion

December 1, 2023

Study Completion

April 4, 2024

Last Updated

December 3, 2025

Record last verified: 2023-06

Locations