Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/01/2017
Date assigned
01/02/2017
Last edited
01/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

GP practices

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2015

Overall trial end date

31/12/2017

Reason abandoned

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

Patient

Age group

Adult

Gender

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.

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

Trial participating centre

Huisartsenmaatschap Holtrop & Sieben
's-Gravesandeplein 19-B
Amsterdam
1091 BB
Netherlands

Trial participating centre

Reinds en Hogewind Huisartsen
Meer en Vaart 58
Amsterdam
1068 ZZ
Netherlands

Trial participating centre

Thiel en van Maanen-Thiel, huisartsen
Ekingenstraat 23
Amsterdam
1069 DA
Netherlands

Trial participating centre

Huisartsencentrum pniël
Bos en lommerweg 189
Amsterdam
1055 DT
Netherlands

Trial participating centre

Gezondheidscentrum Vlaanderen
Laan van Vlaanderen 466
Amsterdam
1066 MT
Netherlands

Trial participating centre

Huisartsenpraktijk van Raalte
Gerard Terborgstraat 46
Amsterdam
1071 TP
Netherlands

Trial participating centre

J.G. van der Veen, Huisarts
Gerard Terborgstraat 46
Amsterdam
1071 TP
Netherlands

Trial participating centre

Huisartsenpraktijk Amsteldorp
Fahrenheitsingel 32
Amsterdam
1097 NS
Netherlands

Trial participating centre

Huisartsenpraktijk Dr. J. van Keimpema
Osdorper Ban 92
Amsterdam
1068 MK
Netherlands

Trial participating centre

Huisartsenpraktijk de Lairesse Acherman & Woertman
De Lairessestraat 42
Amsterdam
1071 PB
Netherlands

Trial participating centre

Huisartsenpraktijk Swart
Pascalstraat 10
Amsterdam
1098 PB
Netherlands

Trial participating centre

Huisartsenpraktijk Reguliersgracht
Reguliersgracht 78C
Amsterdam
1017 LV
Netherlands

Trial participating centre

Gezondheidscentrum Helmersstraat
Anna Spenglerstraat 101
Amsterdam
1054 NJ
Netherlands

Trial participating centre

Huisartsenpraktijk Kappeyne
Nassaukade 116
Amsterdam
1052 EB
Netherlands

Trial participating centre

M Staal Huisarts
Sumatrastraat 84
Amsterdam
1094 NJ
Netherlands

Trial participating centre

Praktijk H.L. Kieviet
Keizer Karelweg 94 C
Amstelveen
1185 HX
Netherlands

Trial participating centre

Huisartspraktijk van Wijngaarden
Lootsstraat 35
Amsterdam
1053 VN
Netherlands

Trial participating centre

Gezondheidscentrum Staatsliedenbuurt
Van Hallstraat 200
Amsterdam
1051 HL
Netherlands

Trial participating centre

Huisartsenpraktijk Nijpels & van Drooge
Meester P.N. Arntzeniusweg 84
Amsterdam
1098 GS
Netherlands

Trial participating centre

Huisartsenpraktijk Oud
Oosterpark 62
Amsterdam
1092 AR
Netherlands

Trial participating centre

Huisartsenpraktijk Luykx
Graaf Aelbrechtlaan 108
Amstelveen
1181 SX
Netherlands

Trial participating centre

Huisartsenpraktijk Javaeiland
Azartplein 45-47
Amsterdam
1019 PA
Netherlands

Trial participating centre

Huisartsenpraktijk Verhaar
C.J. van Houtenlaan 1 C
Weesp
1381 CN
Netherlands

Trial 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

www.acta.nl

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.

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)

Intention to publish date

01/07/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes