Clinical trial NCT05993741: Using AR Dental Care Training on Periodontal Status, Blood Sugar Control and QoL in Patients With Type 2 Diabetes
Official title: Augmented Reality(AR) Training System on Periodontal Health, Blood Sugar Control and Quality of Life in Patients With T2DM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus Type 2 With Periodontal Disease
Keywords: Augmented Reality
Periodontal Health
Blood Sugar Control
Type 2 Diabetes Mellitus
Lead sponsor: Chimei Medical Center
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University
First posted: 2023-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the long-term effectiveness of an AR dental care training in health education on periodontal status, blood sugar control and quality of life in patients with poorly controlled type 2 diabetes. This randomized controlled trial included experimental group: AR group (EG-AR), AR health consulting group (EG-ARHC) and control group (CG), respectively. The EG-AR and EG-ARHC received AR dental care training intervention 2 to 3 times during non-surgical periodontal treatment. Baseline and follow-up surveys were used to collect the data in periodontal index, blood sugar data, oral health knowledge, attitudes, behavior, oral health related quality of life.

Detailed description: A randomized experimental design was used. Patients with type 2 diabetes whose aged 35-65 years and HbA1c over 7% in the past six months were recruited through department of Endocrinology and Metabolism in Chimei Hospital Yongkang and Liuying Campus.

Each group was expected for 100 per group, patients will be randomized into each group. G\*Power (version 3.1.9.4) was used for power analysis. All patients will underwent periodontal examination at baseline and at 1-month, 3-month, 6-month and 1-year follow-ups. Each patients will be diagnosed periodontal disease by dentist and have more than 12 functional teeth. Each patients will completed the questionnaire at baseline and at 1-month, 3- month, 6-month and 1-year follow-ups.

Eligibility criteria: Inclusion Criteria:

* Age 35 years old (inclusive) and above
* HbA1c over 7% in the past six months
* There are more than 12 functional teeth to ensure that the patient has enough teeth to evaluate the periodontal condition

Exclusion Criteria:

* Have received periodontal treatment within the previous 6 months
* Habits of smoking, drugs and betel nut chewing
* Taking antibiotics and osteoporosis bisphosphonates and other drugs regularly
* People with cognitive function or physical and mental disabilities
* Severely impaired diseases (for example: cancer, renal function or liver failure, etc.)

Primary outcomes:
measure: Gingival index (GI)
timeFrame: Change from Baseline GI at 1-month after intervention
measure: Gingival index (GI)
timeFrame: Change from Baseline GI at 3-month after intervention
measure: Gingival index (GI)
timeFrame: Change from Baseline GI at 6-month after intervention
measure: Gingival index (GI)
timeFrame: Change from Baseline GI at 1-year after intervention
measure: Plaque index (PI)
timeFrame: Change from Baseline PI at 1-month after intervention
measure: Plaque index (PI)
timeFrame: Change from Baseline PI at 3-month after intervention
measure: Plaque index (PI)
timeFrame: Change from Baseline PI at 6-month after intervention
measure: Plaque index (PI)
timeFrame: Change from Baseline PI at 1-year after intervention
measure: Probing Pocket Depth (PPD)
timeFrame: Change from Baseline PPD at 1-month after intervention
measure: Probing Pocket Depth (PPD)
timeFrame: Change from Baseline PPD at 3-month after intervention
measure: Probing Pocket Depth (PPD)
timeFrame: Change from Baseline PPD at 6-month after intervention
measure: Probing Pocket Depth (PPD)
timeFrame: Change from Baseline PPD at 1-year after intervention
measure: Clinical Attachment Loss(CAL)
timeFrame: Change from Baseline CAL at 1-month after intervention
measure: Clinical Attachment Loss(CAL)
timeFrame: Change from Baseline CAL at 3-month after intervention
measure: Clinical Attachment Loss(CAL)
timeFrame: Change from Baseline CAL at 6-month after intervention
measure: Clinical Attachment Loss(CAL)
timeFrame: Change from Baseline CAL at 1-year after intervention
measure: Plaque Control Record (PCR)
timeFrame: Change from Baseline PCR at 1-month after intervention
measure: Plaque Control Record (PCR)
timeFrame: Change from Baseline PCR at 3-month after intervention
measure: Plaque Control Record (PCR)
timeFrame: Change from Baseline PCR at 6-month after intervention
measure: Plaque Control Record (PCR)
timeFrame: Change from Baseline PCR at 1-year after intervention
Secondary outcomes:
measure: Oral health knowledge
timeFrame: Change from Baseline at 1-month after intervention
measure: Oral health knowledge
timeFrame: Change from Baseline at 3-month after intervention
measure: Oral health knowledge
timeFrame: Change from Baseline at 6-month after intervention
measure: Oral health knowledge
timeFrame: Change from Baseline at 1-year after intervention
measure: Attitude toward oral health
timeFrame: Change from Baseline at 1-month after intervention
measure: Attitude toward oral health
timeFrame: Change from Baseline at 3-month after intervention
measure: Attitude toward oral health
timeFrame: Change from Baseline at 6-month after intervention
measure: Attitude toward oral health
timeFrame: Change from Baseline at 1-year after intervention
measure: Oral Health Related Quality of Life(OHRQoL)
timeFrame: Change from Baseline at 1-month after intervention
measure: Oral Health Related Quality of Life(OHRQoL)
timeFrame: Change from Baseline at 3-month after intervention
measure: Oral Health Related Quality of Life(OHRQoL)
timeFrame: Change from Baseline at 6-month after intervention
measure: Oral Health Related Quality of Life(OHRQoL)
timeFrame: Change from Baseline at 1-year after intervention
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chimei Medical Center
Study officials:
affiliation: Chimei Medical Center
name: WEI-FU HUANG, MD
role: PRINCIPAL_INVESTIGATOR
References: