The effect of lay health advisor approach of periodontal care intervention for type II diabetes patients

Not Applicable

Completed

• Conditions: Periodontal disease in type II diabetic patients; Oral Health; Periodontal disease

• Registration Number: ISRCTN17756516
• Lead Sponsor: Ministry of Science and Technology, R.O.C.

Brief Summary

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/31635118 results (added 07/04/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34444121/ (added 12/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-18
• Study Completion: 2019-02-01
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Aged between 36 and 65 years
2. Diagnosis of type II diabetes
3. Patients who have at least 16 functional teeth, with 4 or more than 4 supporting zones (minimum of one in the premolar and molar region on each side)-Eichner index: class A
4. Patients who have gingival bleeding
5. Periodontal pockets with a depth of at least 5mm

Exclusion Criteria

1. Periodontitis patients who have undergone periodontal treatment within the last 6 months
2. Regular use of antibiotics and bisphosphonates, or other similar medication
3. Smokers or betel quid chewers, or both users who have quit less than 6 months
4. Systematic diseases (such as cancer, kidney or liver failure, heart disease)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Level of change on oral health-related quality of life is measured using Taiwanese version of the oral health impact profile-14 (OHIP-14T) at baseline, 1, 3 and 6 months<br> 2. Level of change on food intake is measured using food intake questionnaire at baseline, 1, 3 and 6 months<br> 3. Periodontal status (i.e. probing pocket depth, plaque index, gingival index, and clinical attachment loss) is measured using periodontal examination record at baseline, 1, 3 and 6 months<br> 4. The level of change on blood value (i.e. AC Sugar, T-CHO, HDL, LDL, TG, HbA1c, BUN, Creatinine, CRP, Hb(Hct), RBC and MCV) is collected using electronic medical record at baseline, 1, 3 and 6 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Oral health awareness is measured using awareness scale at baseline, 1, 3 and 6 months<br> 2. Attitude towards oral health is measured using attitude toward oral health scale at baseline, 1, 3 and 6 months<br> 3. Self-efficacy is measured using self-efficacy toward oral health scale at baseline, 1, 3 and 6 months<br> 4. Oral health behavior is measured using oral health behaviors questionnaire at baseline, 1, 3 and 6 months<br>