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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN25474337 |
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Date of registration:
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17/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of periodontal non-surgical treatment for pre-diabetes/type 2 diabetes patients
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Scientific title:
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Effect of periodontal non-surgical treatment for pre-diabetes/type 2 diabetes patients: a randomized controlled trial among adults aged 35-54 years |
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Date of first enrolment:
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08/01/2007 |
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Target sample size:
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1399 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN25474337 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial
(Prevention)
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Phase:
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Sherry Yueh-Hsia
Chiu |
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Address:
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No. 259, Wen-Hwa 1st Road, 333 Kwei-Shan
333
Taoyuan
Taiwan |
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Key inclusion & exclusion criteria
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Inclusion criteria: Those aged 35-54 with pre-diabetes/diabetes and without severe diseases (cancer/hospitalization)
Exclusion criteria: 84
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Periodontal disease in pre-diabetes/diabetes for adults aged 35-54 years
Oral Health
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Intervention(s)
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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.
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Primary Outcome(s)
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Periodontal community periodontal index (CPI), measured by periodontal CPI examination and fasting blood chemical biomarker- HbA1C, measured 2 months after the intervention.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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DOH 95-HP-1307
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Source(s) of Monetary Support
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Health Promotion Administration, Ministry of Health and Welfare (Taiwan)
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Results
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Results available:
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Date Posted:
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Date Completed:
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