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

Not Applicable

Completed

• Conditions: Oral Health; Oral-health Associated Quality of Life
• Interventions: Other: Oral Health Tool Box

• Registration Number: NCT04140929
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-24
• Study First Posted: 2019-10-28
• Study Start: 2019-10-31
• Primary Completion: 2023-07-31
• Status Verified: 2023-12
• Study Completion: 2024-04-30
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Oral Health Tool Box	In the intervention group, a range of clinical parameters are recorded and the dentists prepares an individual oral hygiene and care recommendation, based on the Oral Health Tool Box. The Box is also used for instructing the dental assistants and the nursing staff for each patient individually. It is then determined when and how the dental assistants re-evaluates the oral hygiene and care process and reinstructs and remotivates the nursing staff. If the examination reveals a need for dental treatment (possibly requiring referral and transport), this will be communicated to the nursing staff. The dental assistant will further receive a training in communication, enabling them in reinstruction and remotivation. Dentists and dental assistants will further receive a training in geriatric dentistry by the State Commissioner of the German Society for Geriatric Dentistry.

Primary Outcome Measures

Name	Time	Method
General Oral Health Assessment Index (GOHAI)	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 Outcome Measures

Name	Time	Method
Denture Hygiene Index	12 months	Prosthetic hygiene
European Group Quality of life-5 Dimenions-5 Levels (EQ-5D-5L)	12 months	Health-related quality of life
Periodonal Sulcus Index (PSI)	12 months	gingival inflammation
Health economic analysis	12 months	Incidence of dental-associated emergencies and hospitalisations. Nursing,dental and inpatient treatment costs
Geriatric Debris Index (GDI-S)	12 months	Oral hygiene status
Pain scale	12 months	Measurement of actual pain by scale (1-10), 1 -least pain, 10-most pain
Decayed-Missing-Filled-Teeth (DMFT)	12 months	Caries experience/tooth loss, measured with Decayed-Missing-Filled Teeth,and root caries lesions

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany