Effect of periodontal non-surgical treatment for pre-diabetes/type 2 diabetes patients

ISRCTN ISRCTN25474337
DOI https://doi.org/10.1186/ISRCTN25474337
Secondary identifying numbers DOH 95-HP-1307
Submission date
13/07/2015
Registration date
17/08/2015
Last edited
17/08/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Sherry Yueh-Hsia Chiu
Public

No. 259, Wen-Hwa 1st Road, 333 Kwei-Shan
Taoyuan
333
Taiwan

ORCiD logoORCID ID 0000-0002-7207-7088

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available
Scientific titleEffect of periodontal non-surgical treatment for pre-diabetes/type 2 diabetes patients: a randomized controlled trial among adults aged 35-54 years
Study objectivesThe effectiveness of periodontal non-surgical treatment for pre-diabetes/diabetes patuents could improve the status of periodontal status
Ethics approval(s)Institutional Review Board, Ethics Committee of Chang Gung Memorial Hospital, 05/09/2014, ref: 103-3920B
Health condition(s) or problem(s) studiedPeriodontal disease in pre-diabetes/diabetes for adults aged 35-54 years
InterventionParticipants 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 typeMixed
Primary outcome measurePeriodontal community periodontal index (CPI), measured by periodontal CPI examination and fasting blood chemical biomarker- HbA1C, measured 2 months after the intervention.
Secondary outcome measuresKnowledge 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 study start date01/08/2006
Completion date30/03/2008

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participants1399
Key inclusion criteriaThose aged 35-54 with pre-diabetes/diabetes and without severe diseases (cancer/hospitalization)
Key exclusion criteria84
Date of first enrolment08/01/2007
Date of final enrolment30/01/2008

Locations

Countries of recruitment

  • Taiwan

Study participating centres

Health Bureau of Keelung City
No.266, Sin 2nd Rd., Sinyi District
Keelung City
201
Taiwan
Dr. Lo Dental Clinic
2F, No. 7, Jen-Ai district, 3rd Jen Rd.
Keelung City
208
Taiwan

Sponsor information

Health Promotion Administration, Ministry of Health and Welfare
Government

6F., No.95, Mincyuan Rd., West District
Taichung
40341
Taiwan

ROR logo "ROR" https://ror.org/024w0ge69

Funders

Funder type

Government

Health Promotion Administration, Ministry of Health and Welfare (Taiwan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan
IPD sharing plan