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Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction

Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction - a Cluster-randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04140929
Acronym
MundZaRR
Enrollment
358
Registered
2019-10-28
Start date
2019-10-31
Completion date
2024-04-30
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health, Oral-health Associated Quality of Life

Keywords

nursing homes, oral hygiene, quality of life, health services research

Brief summary

Based on the poor situation of residents in German nursing homes with regard to oral health, a cluster-randomized Trial will be carried out in Rhineland-Palatindate, Germany. Dentists investigated residents to identify dental or oral hygiene problems. In the invention group, dentists' recommendations will be reinstructed to the nursing staff by dental assistance.

Detailed description

Introduction: Oral health and oral-health-associated quality-of-life (OHrQL) of residents in German nursing homes are poor. The investigators will develop an evidence-based catalogue of interventions applicable and sustainable (Oral Health Tool Box). Based on this, care-accompanying reinstruction and remotivation of nursing staff by dental assistants (DA) will be provided. The investigators hypothesize such complex intervention to significantly improve OHrQL, and daily oral hygiene/care behaviour and its cost-effectiveness. Methods and analysis: Based on the findings of a rapid systematic review, possible intervention components will be systematized and assessed for their effectiveness. Mixed methods will be used to identify barriers and enablers of oral hygiene and care in German long-term residential care (LRC), and these will be linked with the intervention components using the Theoretical Domains Framework and the Behavior Change Wheel, the result being an Oral Health Tool Box. A two-arm cluster, randomized-controlled-trial (ratio of 1:1 via block randomization) will be performed in nursing homes in Rhineland-Palatinate, Germany, including residents with moderate to severe care dependency. Each nursing home represents a cluster. Based on a feasibility study, considering clustering and possible attrition, the investigators aim at recruiting 618 residents of 18 cluster. In the intervention group, dentists will identify the specific problems of each resident, and assign one or more intervention components from the box. During follow-up, nursing staff will be reinstructed and remotivated by dental assistants in how to deliver the intervention components in individual intervals. In the control group residents will receive care as usual. The primary outcome, OHrQL, will be measured using the German version of the General Oral Health Assessment Index (GOHAI). Secondary outcomes include pain condition, general health-related quality-of-life, caries increment, oral/prothetic hygiene and gingival status, incidence of dental emergencies and hospitalizations, and cost-utility/effectiveness. The endpoints will be measured at baseline and after 12 months. For the primary outcome, a mixed-linear model will be used within an intention-to-treat analysis. A process evaluation using mixed methods will be conducted alongside the trial. Due to the pandemic, the number of cases could not be reached despite outstanding commitment in recruitment. An application was made to the funding agency to adapt the project plan.

Interventions

OTHEROral Health Tool Box

Please see, description of the intervention group

Sponsors

Jena University Hospital
CollaboratorOTHER
Martin-Luther-Universität Halle-Wittenberg
CollaboratorOTHER
University of Applied Sciences, Cologne, Germany
CollaboratorUNKNOWN
Charite University, Berlin, Germany
CollaboratorOTHER
University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Cluster-randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Nursing homes without an existing dental cooperation agreement. Eligible are residents with a degree of care dependency of 3 to 5 (moderate to severe) as rated by an expert rater of the German statutory health insurance.

Exclusion criteria

* lack of consent (of the home management and/or the residents or their proxies or legal guardians) and residents in respite carer

Design outcomes

Primary

MeasureTime frameDescription
General Oral Health Assessment Index (GOHAI)12 monthsThe GOHAI is an established instrument for measuring oral health-related quality of life (OHRQoL) in older people. It comprises twelve items in four domains (functional limitations, pain/discomfort, psychological aspects, behavioral aspects), which are recorded ordinally scaled from 0 (never true) to 5 (always true).

Secondary

MeasureTime frameDescription
European Group Quality of life-5 Dimenions-5 Levels (EQ-5D-5L)12 monthsHealth-related quality of life
Decayed-Missing-Filled-Teeth (DMFT)12 monthsCaries experience/tooth loss, measured with Decayed-Missing-Filled Teeth,and root caries lesions
Geriatric Debris Index (GDI-S)12 monthsOral hygiene status
Pain scale12 monthsMeasurement of actual pain by scale (1-10), 1 -least pain, 10-most pain
Denture Hygiene Index12 monthsProsthetic hygiene
Health economic analysis12 monthsIncidence of dental-associated emergencies and hospitalisations. Nursing,dental and inpatient treatment costs
Periodonal Sulcus Index (PSI)12 monthsgingival inflammation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026