Oral HealthMundZaRRNCT04140929
Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction
A study testing Oral Health Tool Box in people with Oral Health and Oral-health Associated Quality of Life, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Oral-health Associated Quality of Life
- What is being tested?
- Oral Health Tool Box
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteGermany
- Study dates
- 31 Oct 2019to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- lack of consent (of the home management and/or the residents or their proxies or legal guardians) and residents in respite carer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction - a Cluster-randomized Controlled Trial
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.
Read the 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.
- Being tested
- Oral Health Tool Box
- Keywords
- nursing homes, oral hygiene, quality of life, health services research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Tool BoxOther
Please see, description of the intervention group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (7)
Pain scale
Measurement of actual pain by scale (1-10), 1 -least pain, 10-most pain
Measured: 12 months
European Group Quality of life-5 Dimenions-5 Levels (EQ-5D-5L)
Health-related quality of life
Measured: 12 months
Decayed-Missing-Filled-Teeth (DMFT)
Caries experience/tooth loss, measured with Decayed-Missing-Filled Teeth,and root caries lesions
Measured: 12 months
Geriatric Debris Index (GDI-S)
Oral hygiene status
Measured: 12 months
Periodonal Sulcus Index (PSI)
gingival inflammation
Measured: 12 months
Denture Hygiene Index
Prosthetic hygiene
Measured: 12 months
Health economic analysis
Incidence of dental-associated emergencies and hospitalisations. Nursing,dental and inpatient treatment costs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start31 Oct 2019
- Primary completion31 Jul 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Jena University Hospital, Martin-Luther-Universität Halle-Wittenberg, University of Applied Sciences, Cologne, Germany, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Katrin Hertrampf, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140929
- Sponsor's protocol ID
- 01VSF18021
- Acronym
- MundZaRR
- Status last verified
- Dec 2023
- First submitted
- 24 Oct 2019
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After completion of the whole study, the results will be published
Publications
Wobst LM, Abraham J, Habig S, Gabelmann S, Gassmann G, Schwendicke F, Schlattmann P, Orawa H, Hertrampf K, Meyer G. Recruitment of nursing homes and residents in a cluster-randomised controlled trial to improve oral health (MundZaRR): a structured analysis of trials and tribulations. Trials. 2026 Mar 13;27(1):280. doi: 10.1186/s13063-026-09607-5.
PubMed 41827070Nordblom 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.
PubMed 39673909Hertrampf 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.
PubMed 32978183
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Improvement for Nursing Home Residents Through Delegated Remotivation and Reinstruction - a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04140929
- Acronym / sponsor ID
- MundZaRR / 01VSF18021
- Keywords
- nursing homes, oral hygiene, quality of life, health services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Jena University Hospital, Martin-Luther-Universität Halle-Wittenberg, University of Applied Sciences, Cologne, Germany, Charite University, Berlin, Germany
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Oral Health Tool BoxIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- lack of consent (of the home management and/or the residents or their proxies or legal guardians) and residents in respite carer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Health Tool BoxPlease see, description of the intervention group | Other | Intervention group |
Primary outcome
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).
7 secondary outcomes
Pain scale
Time frame: 12 months
European Group Quality of life-5 Dimenions-5 Levels (EQ-5D-5L)
Time frame: 12 months
Decayed-Missing-Filled-Teeth (DMFT)
Time frame: 12 months
Geriatric Debris Index (GDI-S)
Time frame: 12 months
Periodonal Sulcus Index (PSI)
Time frame: 12 months
Denture Hygiene Index
Time frame: 12 months
Health economic analysis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 41827070Wobst LM, Abraham J, Habig S, Gabelmann S, Gassmann G, Schwendicke F, Schlattmann P, Orawa H, Hertrampf K, Meyer G. Recruitment of nursing homes and residents in a cluster-randomised controlled trial to improve oral health (MundZaRR): a structured analysis of trials and tribulations. Trials. 2026 Mar 13;27(1):280. doi: 10.1186/s13063-026-09607-5.
- Derived from this study: PubMed 39673909Nordblom 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.
- Derived from this study: PubMed 32978183Hertrampf 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.
- Individual participant dataSharing planned: No. After completion of the whole study, the results will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health Tool Box in people with Oral Health and Oral-health Associated Quality of Life, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Oral Health Assessment Index (GOHAI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140929, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.