Plain English Summary
Background and study aims
People with diabetes are as greater risk for periodontal (gum) disease than the general population. While dental scaling and root planning works well for treating early periodontal disease (PD), little is known about how well preventive non-surgical treatment for periodontal disease works among pre-diabetes/diabetes patients, especially for middle aged people 35-54. The aim of this study is to evaluate the effectiveness of periodontal non-surgical treatment on pre-diabetes/diabetes patients.
Who can participate?
Adults aged 35-54 with pre-diabetes/diabetes.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention) are given the preventive non-surgical PD treatment (intervention). This includes checking with each participant how much they already know and an assessment on how bad their PD is. They are then given instructions on how best to use the tooth brush and dental floss, information on the causes and signs of PD, link between hyperglycemia (high blood sugar) and PD and general oral practice. Those in group 2 (control) are not given the intervention. All participants PD is assessed 2 months later, along with their knowledge of oral hygiene and PD.
What are the possible benefits and risks of participating?
Participants in the intervention group may get some positive benefit from the non-surgical PD treatment. There are no risks.
Where is the study run from?
Health Bureau of Keelung City and the Dr. Lo Dental Clinic (Taiwan)
When is the study starting and how long is it expected to run for?
August 2006 to March 2008
Who is funding the study?
Health Promotion Administration, Ministry of Health and Welfare (Taiwan)
Who is the main contact?
Dr Sherry Yueh-Hsia Chiu
Trial website
Contact information
Type
Public
Primary contact
Dr Sherry Yueh-Hsia Chiu
ORCID ID
http://orcid.org/0000-0002-7207-7088
Contact details
No. 259
Wen-Hwa 1st Road
333 Kwei-Shan
Taoyuan
333
Taiwan
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DOH 95-HP-1307
Study information
Scientific title
Effect of periodontal non-surgical treatment for pre-diabetes/type 2 diabetes patients: a randomized controlled trial among adults aged 35-54 years
Acronym
Study hypothesis
The effectiveness of periodontal non-surgical treatment for pre-diabetes/diabetes patuents could improve the status of periodontal status
Ethics approval
Institutional Review Board, Ethics Committee of Chang Gung Memorial Hospital, 05/09/2014, ref: 103-3920B
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available
Condition
Periodontal disease in pre-diabetes/diabetes for adults aged 35-54 years
Intervention
Participants were randomly allocated into either the intervention or the control group. The intervention included oral hygiene instruction and periodontal disease (PD) care and periodontal non-surgical treatment. The oral hygiene instruction was carried out by senior professional dental nurses individually. The contents included tooth brush, dental floss use, the causes and signs of PD, association between hyperglycemia and PD, and general oral hygiene practice. Periodontal non-surgical intervention was implemented by three dentists with profession in PD treatment with more than 10-year expertise, which were calibrated CPI examination and standardized procedure of non-surgical periodontal treatment were performed before study implementation. baseline of PD status were examined for six sextants and recorded by CPI (Community Periodontal Index), that included 0 for healthy periodontium, 1 for gingival bleeding, 2 for calculus, 3 for a 4-5mm periodontal pocket, and 4 for a >6mm periodontal pocket. Considering the feasibility and manpower, the severest quarter was taken as treatment site for intervention group compared with no treatment on control. After the follow-up measure, the non-surgical periodontal treatment was compensated for subjects in control group.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Periodontal community periodontal index (CPI), measured by periodontal CPI examination and fasting blood chemical biomarker- HbA1C, measured 2 months after the intervention.
Secondary outcome measures
Knowledge of oral hygiene and periodontal disease, assessed using a questionnaire of knowledge and attitude for periodontal health and oral hygiene. This was collected after 2 months after the intervention.
Overall trial start date
01/08/2006
Overall trial end date
30/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Those aged 35-54 with pre-diabetes/diabetes and without severe diseases (cancer/hospitalization)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
1399
Participant exclusion criteria
84
Recruitment start date
08/01/2007
Recruitment end date
30/01/2008
Locations
Countries of recruitment
Taiwan
Trial participating centre
Health Bureau of Keelung City
No.266, Sin 2nd Rd., Sinyi District
Keelung City
201
Taiwan
Trial participating centre
Dr. Lo Dental Clinic
2F, No. 7, Jen-Ai district, 3rd Jen Rd.
Keelung City
208
Taiwan
Funders
Funder type
Government
Funder name
Health Promotion Administration, Ministry of Health and Welfare (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary