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Completed

NCT Number: NCT04140929

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Schleswig-Holstein

Kiel, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Health Tool Box

Other

Please see, description of the intervention group

Primary outcomes

  1. General Oral Health Assessment Index (GOHAI)

    Time frame: 12 months

    The 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 outcomes

  1. Pain scale

    Time frame: 12 months

    Measurement of actual pain by scale (1-10), 1 -least pain, 10-most pain

  2. European Group Quality of life-5 Dimenions-5 Levels (EQ-5D-5L)

    Time frame: 12 months

    Health-related quality of life

  3. Decayed-Missing-Filled-Teeth (DMFT)

    Time frame: 12 months

    Caries experience/tooth loss, measured with Decayed-Missing-Filled Teeth,and root caries lesions

  4. Geriatric Debris Index (GDI-S)

    Time frame: 12 months

    Oral hygiene status

  5. Periodonal Sulcus Index (PSI)

    Time frame: 12 months

    gingival inflammation

  6. Denture Hygiene Index

    Time frame: 12 months

    Prosthetic hygiene

  7. Health economic analysis

    Time frame: 12 months

    Incidence of dental-associated emergencies and hospitalisations. Nursing,dental and inpatient treatment costs

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • Charite University, Berlin, Germany
  • Jena University Hospital
  • Martin-Luther-Universität Halle-Wittenberg
  • University of Applied Sciences, Cologne, Germany

Registry information

Official study title

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

Acronym: MundZaRR

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Oct 28, 2019
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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