## Protocol Section
### Identification Module
**NCT ID:** NCT06397079

**Brief Title:** Oral Care Program for Residients in Long-term Care Facility

**Official Title:** Investigation of Effect on Oral Care Program for Residents in Long-term Care Facility

#### Organization Study ID Info
**ID:** CTH-113-3-5-004
#### Organization
**Class:** OTHER
**Full Name:** National Taipei University of Nursing and Health Sciences
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-06

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-02

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-02
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-04-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Taipei University of Nursing and Health Sciences

#### Responsible Party

**Investigator Affiliation:** National Taipei University of Nursing and Health Sciences

**Investigator Full Name:** En-Chi Chiu

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this study is to investigate the effectiveness of an oral care program on the oral hygiene for residents in long-term care facility.

**Detailed Description:** The study adopts a randomized clinical trial design and utilizes a cross-over design. The main outcomes include assessments of oral health (Oral Health Assessment Tool, Oral Health Impact Profile, Geriatric Oral Health Assessment Index), tongue coating cleanliness (Tongue Coating Index), dental plaque and gum cleanliness (Plaque Index, Gingival Index, Gingival Bleeding Index), and swallowing ability (Eating Assessment Tool, Function Oral Intake Scale, International Dysphagia Diet Standardisation Initiative).

### Conditions Module

**Conditions:**

- Elder

- Oral Hygiene

**Keywords:**

- elder

- oral hygiene

- long-term care facility

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Teach Bass brushing technique and use electric toothbrush

**Intervention Names:**

- Behavioral: Electric toothbrush

**Label:** Electric toothbrush

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Teach Bass brushing technique and use soft bristle toothbrush

**Intervention Names:**

- Behavioral: Soft bristle toothbrush

**Label:** Soft bristle toothbrush

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Electric toothbrush

**Description:** Teach Bass brushing technique and bursh teeth using electric toothbrush dental hygiene three times a day.

**Name:** Electric toothbrush

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Soft bristle toothbrush

**Description:** Teach Bass brushing technique and bursh teeth using soft bristle toothbrush dental hygiene three times a day.

**Name:** Soft bristle toothbrush

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The Oral Health Assessment Tool is a scale for evaluating oral health. The score ranges is 0 to 16. A higher score indicates a poorer oral health condition.

**Measure:** Oral Health Assessment Tool

**Time Frame:** Baseline to 4 weeks

**Description:** The Oral Health Impact Profile assesses the quality of oral health-related life. The score ranges is 0 to 56. A higher score indicates poorer oral health-related quality of life.

**Measure:** Oral Health Impact Profile

**Time Frame:** Baseline to 4 weeks

**Description:** The Geriatric Oral Health Assessment Index evaluates oral health for older people. The score ranges is 12 to 60. A higher score indicates better oral health.

**Measure:** Geriatric Oral Health Assessment Index

**Time Frame:** Baseline to 4 weeks

**Description:** The Tongue Coating Index assesses tongue cleanliness. The score ranges is 0 to 18. A higher core indicates lower cleanliness of the tongue.

**Measure:** Tongue Coating Index

**Time Frame:** Baseline to 4 weeks

**Description:** Plaque Index assesses amount of dental plaque. The score ranges is 0 to 3. A higher score indicates lower amount of dental plaque.

**Measure:** Plaque Index

**Time Frame:** Baseline to 4 weeks

**Description:** The Gingival Index assesses gingival health. The score ranges is 0 to 3. A higher score indicates poorer gingival health.

**Measure:** Gingival Index

**Time Frame:** Baseline to 4 weeks

**Description:** The Gingival Bleeding Index assesses gingival health. The score ranges is 0 to 1. A higher score indicates poorer gingival health.

**Measure:** Gingival Bleeding Index

**Time Frame:** Baseline to 4 weeks

**Description:** The Eating Assessment Tool evaluates the degree of swallowing status. The score ranges is 0 to 40. A higher score indicates lower swallowing ability.

**Measure:** Eating Assessment Tool

**Time Frame:** Baseline to 4 weeks

**Description:** The Functional Oral Intake Scale assesses swallowing ability. The score ranges is 1 to 7. A higher score indicates greater swallowing ability.

**Measure:** Function Oral lntake Scale

**Time Frame:** Baseline to 4 weeks

**Description:** The International Dysphagia Diet Standardisation Initiative assesses swallowing ability. The score ranges is 0 to 7. A higher score indicates greater swallowing ability.

**Measure:** International Dysphagia Diet Standardisation Initiative

**Time Frame:** Baseline to 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Eating by mouth
2. Able to express fluently in Chinese after correcting vision and hearing
3. Normal hand functions
4. Able to follow instructions
5. Willing to participate in the study and sign the informed consent

Exclusion Criteria:

1. Unconsicous
2. Diagnosis of dementia and inability to communicate
3. Having a tracheostomy tube and nasogastric tube
4. Unable to move both upper limbs
5. Bedridden
6. Vulnerable populations (e.g., political, economic, or socially disadvantaged groups)

**Maximum Age:** 99 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** enchichiu@ntunhs.edu.tw

**Name:** En-Chi Chiu, PhD

**Phone:** +886-2-28227101

**Phone Ext:** 1291

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Taipei City

**Contacts:**

***Contact 1:***

- **Email:** enchichiu@ntunhs.edu.tw

- **Name:** En-Chi Chiu, PhD

- **Phone:** +886-2-28227101

- **Phone Ext:** 1291

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** Cardinal Tien Hospital

**State:** Xindian Dist

**Zip:** 231403

#### Overall Officials

**Official 1:**

**Affiliation:** National Taipei University of Nursing and Health Sciences

**Name:** En-Chi Chiu, PhD

**Role:** STUDY_DIRECTOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
