Condition category
Oral Health
Date applied
13/07/2015
Date assigned
17/08/2015
Last edited
17/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Health Promotion Administration, Ministry of Health and Welfare

Sponsor details

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

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes