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

Follow-up evaluation study by the lay health advisor (LHA) approach of periodontal care intervention for type ii diabetes patients: assessment, LHA training, and effects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17756516

Enrollment

200

Registered

2015-11-18

Start date

2015-11-20

Completion date

Unknown

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal disease in type II diabetic patients Oral Health Periodontal disease

Interventions

Participants will be randomly assigned by their sequence of date they signed inform consent form to the LHA intervention group or to a brochure-only control group. Both the intervention and control gr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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 2. Level of change on food intake is measured using food intake questionnaire at baseline, 1, 3 and 6 months 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 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	—

Measure

Time frame

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 2. Level of change on food intake is measured using food intake questionnaire at baseline, 1, 3 and 6 months 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 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

—

Secondary

Measure	Time frame
1. Oral health awareness is measured using awareness scale at baseline, 1, 3 and 6 months 2. Attitude towards oral health is measured using attitude toward oral health scale at baseline, 1, 3 and 6 months 3. Self-efficacy is measured using self-efficacy toward oral health scale at baseline, 1, 3 and 6 months 4. Oral health behavior is measured using oral health behaviors questionnaire at baseline, 1, 3 and 6 months	—

Measure

Time frame

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

—

Countries

Afghanistan, Taiwan, Tokelau, Tunisia, Turkey, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States Minor Outlying Islands, United States of America, Uruguay, Uzbekistan, Vanuatu, Venezuela, Viet Nam, Virgin Islands, British, Virgin Islands, U.S., Wallis and Futuna, Western Sahara

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026