Plain English Summary
Background and study aims
Type 2 diabetes mellitus (T2DM) is a long term condition where sufferers have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). High blood sugar levels can lead to a range of complications, including damage to the eyes, kidneys and nerves. In the Netherlands, diabetic patients are treated in the primary diabetes care system (so-called "ketenzorg", or chain care), in which several medical specialists work together closely. Patients are checked regularly for the traditional complications, and treated if necessary, to improve their health and quality of life. Besides the classic complications, there is evidence that T2DM can lead to oral (mouth) complications, such as gum disease (periodontitis), dry mouth and mouth ulcers. This has led to the formation of guidelines for the medical community on how to deal with oral health in diabetes mellitus patients. These guidelines encourage close collaboration between healthcare professionals and dental specialists. Regardless of the existence of these guidelines, until now, the Dutch GPs pay little to no attention to oral health, simply because they lack the knowledge, resources and time to do so. Furthermore, the collaboration between GPs and dentists is non-existent. The aim of this study is to look at the effectiveness of incorporating oral care into primary care to see if it can improve the oral health and quality of life of T2DM patients.
Who can participate?
Adults who have T2DM
What does the study involve?
Participating GP practices are included and randomly assigned to either the experimental or control group. The general practitioners or nurse practitioners in the experimental group inform their diabetic patients about the relationship between diabetes and oral health. They also encourage their patients to visit a dentist, using a referral form. The patients also receive an introduction kit that contains preventive dental care products and an information brochure. In the control group, the diabetes care professionals do not pay extra attention to oral health, and perform their usual care protocol. At the start of the study and then again after one year, participants in both groups complete a range of questionnaires to measure their quality of life and have their mouths examined by dentists to assess their oral health.
What are the possible benefits and risks of participating?
Participating in this study will make patients aware of the importance of their oral health, which could lead to them visiting the dentist more often. This could help in the prevention and treatment of oral complications, such as periodontitis and dry mouth, improving their quality of life. There are no anticipated risks involved with participating.
Where is the study run from?
24 GP practices located in the area of Amsterdam (Netherlands)
When is study starting and how long is it expected to run for?
January 2015 to December2017
Who is funding the study?
Sunstar Suisse SA (Switzerland)
Who is the main contact?
Mr Martin Verhulst
m.verhulst@acta.nl
Study website
Contact information
Type
Scientific
Contact name
Mr Martijn Verhulst
ORCID ID
Contact details
Academisch Centrum Tandheelkunde Amsterdam
Afdeling Mondgezondheidswetenschappen
sectie Parodontologie & Orale Biochemie
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
+31 20 598 0173
m.verhulst@acta.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
14/585
Study information
Scientific title
Best practice model for interdisciplinary medicine in treating diabetes patients. The need for implementation of oral care
Acronym
Study hypothesis
Primary research questions:
1. Will incorporation of oral care, using a strict protocol, in primary diabetes care result in improvement of diagnosis of oral complications, like periodontitis and other oral diseases?
2. Will the improvement in diagnosis of oral diseases lead to prevention and/or treatment of oral complications?
3. Will this preventive strategy, including the use of oral care products, lead to improvement of oral health, general health and quality of life in diabetes patients?
Ethics approval(s)
The Medical Ethics Review Committee VU University Medical Center (registered with the OHRP as IRB00002991) discussed the application. On 29 January 2015, it was confirmed that the Medical Research Involving Human Subjects ACT (WMO) did not apply for this study, and an official approval of this study by the committee was not required.
Study design
Multi-centre cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
GP practice
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes Mellitus Type 2
Intervention
24 participating GP practices are randomly 24 participating GP practices are randomly allocated to either the control group or the intervention group, using the SNOSE (sequentially numbered, opaque, sealed envelopes) protocol.
Intervention group: Nurse practitioners at participating practices are were instructed to pay extra attention to oral health during their consultation hours, on top of their usual care. This consists of:
1. Informing the diabetes patients about the relationship between oral health and diabetes mellitus, and emphasizing it’s important to take care of their oral health.
2. Actively stimulating the patients to visit the dentist at least once/twice a year, using a standard referral letter. This referral letter also contained a return form, meant for the dentist. When the patient actually visited the dental office, the dentist would fill in this form and send it back to the GP practice.
3. Providing the patients with an introduction kit, containing (preventive) oral care products (e.g. oral rinse, tooth paste, interdental brushes etc.)
Control group: Nurse practitioners provide care as usual, without paying extra attention to oral health.
For all participants, the follow-up time is 12 months. Usually, a patient visits the GP/nurse practitioner every three months in the Dutch primary care, and these moments were used to continue motivating the participating patients to visit a dentist during the 12 months follow-up.
Intervention type
Behavioural
Primary outcome measure
1. Self-reported oral health, using a questionnaire based on large epidemiological studies from the United States, measured at baseline and 12 months
2. Oral health is assessed using an oral examination by a dentist at baseline and 12 months
3. Oral health related quality of life is assessed using the OHIP-14 questionnaire at baseline and 12 months
4. General quality of life is assessed using the SF-36 questionnaire at baseline and 12 months
Secondary outcome measures
Parameters of protocolization and optimalization:
1. Number of patients which are referred to a specialist by the dentist during the 12 months follow up. This is registered by the dentist on the return form that the patient received at baseline.
2. Number of patients which are seen by the dentist is measured by the number of return forms that the GP practices received during the 12 months follow-up
3. Number of patients which are treated by the dentist is registered on the return forms that the they received during the 12 months follow-up
4. Feasibility and effectiveness of our intervention protocol is assessed using a questionnaire related to the opinion of diabetes practitioners, measured as soon as they finished the follow-up period.
Change in general health as recorded by the diabetes practitioner:
1. Number and severity of diabetes-related complications is assessed through medical record review at baseline and 12 months
2. (Bio)markers of metabolic control of diabetes mellitus (Glucose, HbA1c, Lipids, etc..) is assessed through medical record review at baseline and 12 months
3. General characteristics (BMI, smoking habits, diet, etc..) is assessed through medical record review at baseline and 12 months
4. Medication use is assessed through medical record review at baseline and 12 months
Overall study start date
01/01/2015
Overall study end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years and over
2. Diabetes mellitus Type 2
3. Follows the standardized primary diabetes care protocol
4. Understands spoken and written Dutch
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
There are 24 clusters, which aim to include 100 patients each. This brings the total target number of participants at 2400.
Total final enrolment
764
Participant exclusion criteria
1. Don't understand spoken and written Dutch
2. Attend secondary diabetes care (i.e. internal medicine at the hospital)
Recruitment start date
01/03/2015
Recruitment end date
07/09/2016
Locations
Countries of recruitment
Netherlands
Study participating centre
Huisartsenmaatschap Holtrop & Sieben
's-Gravesandeplein 19-B
Amsterdam
1091 BB
Netherlands
Study participating centre
Reinds en Hogewind Huisartsen
Meer en Vaart 58
Amsterdam
1068 ZZ
Netherlands
Study participating centre
Thiel en van Maanen-Thiel, huisartsen
Ekingenstraat 23
Amsterdam
1069 DA
Netherlands
Study participating centre
Huisartsencentrum pniël
Bos en lommerweg 189
Amsterdam
1055 DT
Netherlands
Study participating centre
Gezondheidscentrum Vlaanderen
Laan van Vlaanderen 466
Amsterdam
1066 MT
Netherlands
Study participating centre
Huisartsenpraktijk van Raalte
Gerard Terborgstraat 46
Amsterdam
1071 TP
Netherlands
Study participating centre
J.G. van der Veen, Huisarts
Gerard Terborgstraat 46
Amsterdam
1071 TP
Netherlands
Study participating centre
Huisartsenpraktijk Amsteldorp
Fahrenheitsingel 32
Amsterdam
1097 NS
Netherlands
Study participating centre
Huisartsenpraktijk Dr. J. van Keimpema
Osdorper Ban 92
Amsterdam
1068 MK
Netherlands
Study participating centre
Huisartsenpraktijk de Lairesse Acherman & Woertman
De Lairessestraat 42
Amsterdam
1071 PB
Netherlands
Study participating centre
Huisartsenpraktijk Swart
Pascalstraat 10
Amsterdam
1098 PB
Netherlands
Study participating centre
Huisartsenpraktijk Reguliersgracht
Reguliersgracht 78C
Amsterdam
1017 LV
Netherlands
Study participating centre
Gezondheidscentrum Helmersstraat
Anna Spenglerstraat 101
Amsterdam
1054 NJ
Netherlands
Study participating centre
Huisartsenpraktijk Kappeyne
Nassaukade 116
Amsterdam
1052 EB
Netherlands
Study participating centre
M Staal Huisarts
Sumatrastraat 84
Amsterdam
1094 NJ
Netherlands
Study participating centre
Praktijk H.L. Kieviet
Keizer Karelweg 94 C
Amstelveen
1185 HX
Netherlands
Study participating centre
Huisartspraktijk van Wijngaarden
Lootsstraat 35
Amsterdam
1053 VN
Netherlands
Study participating centre
Gezondheidscentrum Staatsliedenbuurt
Van Hallstraat 200
Amsterdam
1051 HL
Netherlands
Study participating centre
Huisartsenpraktijk Nijpels & van Drooge
Meester P.N. Arntzeniusweg 84
Amsterdam
1098 GS
Netherlands
Study participating centre
Huisartsenpraktijk Oud
Oosterpark 62
Amsterdam
1092 AR
Netherlands
Study participating centre
Huisartsenpraktijk Luykx
Graaf Aelbrechtlaan 108
Amstelveen
1181 SX
Netherlands
Study participating centre
Huisartsenpraktijk Javaeiland
Azartplein 45-47
Amsterdam
1019 PA
Netherlands
Study participating centre
Huisartsenpraktijk Verhaar
C.J. van Houtenlaan 1 C
Weesp
1381 CN
Netherlands
Study participating centre
Huisartsen Diemen Centrum; Praktijk Bruinsel & Praktijk van Griek
Prinses Beatrixlaan 7
Diemen
1111 EX
Netherlands
Sponsor information
Organisation
Academisch Centrum Tandheelkunde Amsterdam
Sponsor details
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
Sponsor type
University/education
Website
ROR
Funders
Funder type
Industry
Funder name
Sunstar Suisse SA
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal, aimed at primary care professionals.
Intention to publish date
01/07/2019
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Martijn Verhulst (m.verhulst@acta.nl)
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | 18/06/2019 | 15/03/2023 | Yes | No | |
Results article | 10/05/2021 | 15/03/2023 | Yes | No |