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

NCT04140929 | Completed

• 1 other identifier: 01VSF18021
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health; Oral-health Associated Quality of Life

Keywords

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

Outcome Measures

Primary Outcomes (1)

• General Oral Health Assessment Index (GOHAI)

  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).

  12 months

Secondary Outcomes (7)

• Pain scale

  12 months

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

  12 months

• Decayed-Missing-Filled-Teeth (DMFT)

  12 months

• Geriatric Debris Index (GDI-S)

  12 months

• Periodonal Sulcus Index (PSI)

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Oral Health Tool Box

Control group

NO INTERVENTION

In the control group, the residents receive care as usual. This includes the recording of the same parameters are recorded as in intervention group, a standardized form is filled out and handed over to the nursing staff. As in the case of Intervention group, the nursing staff is informed in the event of a need for treatment. No further measures are applied.

Interventions

Oral Health Tool Box OTHER

Please see, description of the intervention group

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• Jena University Hospital: collaborator
• Martin-Luther-Universität Halle-Wittenberg: collaborator
• University of Applied Sciences, Cologne, Germany: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

University Hospital Schleswig-Holstein

Kiel, Germany

Location

Related Publications (2)

• Nordblom NF, Hertrampf K, Habig S, Gabelmann S, Schlattmann P, Orawa H, Meyer G, Gassmann G, Abraham J, Wobst LM, Schwendicke F. Cost-effectiveness-analysis of oral health remotivation and reinstruction in nursing homes in a cluster-randomized controlled trial. J Dent. 2025 Feb;153:105520. doi: 10.1016/j.jdent.2024.105520. Epub 2024 Dec 13.

  PMID: 39673909 DERIVED

• Hertrampf K, Schlattmann P, Meyer G, Gassmann G, Abraham J, Hammen V, Schwendicke F. Oral health improvement for nursing home residents through delegated remotivation and reinstruction (MundZaRR Study): study protocol of a cluster-randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e035999. doi: 10.1136/bmjopen-2019-035999.

  PMID: 32978183 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Cluster-randomized controlled trial

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: October 31, 2019
• Primary Completion: July 31, 2023
• Study Completion: April 30, 2024
• Last Updated: April 1, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)