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

• Register: ISRCTN
• Last refreshed on: 22 August 2022
• Main ID: ISRCTN17756516
• Date of registration: 18/11/2015
• Prospective Registration: Yes
• Primary sponsor: Ministry of Science and Technology, R.O.C.
• Public title: The effect of lay health advisor approach of periodontal care intervention for type II diabetes patients
• Scientific title: 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
• Date of first enrolment: 20/11/2015
• Target sample size: 200
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN17756516
• Study type: Interventional
• Study design: Randomized controlled trial (Not Specified)
• Phase: Not Applicable

Countries of recruitment

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

Contacts

• Name: Hsiao-Ling Huang

Key inclusion & exclusion 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:
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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Periodontal disease in type II diabetic patients
Oral Health
Periodontal disease

Intervention(s)

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 groups will receive non-surgical periodontal treatment (NSPT) including scaling, root planning and oral hygiene instruction.

LHV intervention group: In addition to the conventional periodontal therapy (subgingival scaling and root planning), participants will receive additional professional oral health education by a well-trained lay health advisor (LHA) during NSPT period, lasting for 30 minutes, as well as instruction once a week for 4-5 weeks.

Brochure-only control group: In addition to the conventional periodontal therapy, participants receive a brochure providing information about oral health.

The follow-up surveys will conduct at 1, 3 and 6 months after they finished treatment.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

N/A

Source(s) of Monetary Support

Ministry of Science and Technology, R.O.C.

Ethics review

Status:
Approval date:
Contact:

Institutional review board of Kaohsiung Medical University Chung-Ho Memorial Hospital, 16/10/2015, ref: KMUH-IRB-20140291

Results

• Results available: Yes
• Date Completed: 01/02/2019