NCT06397079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

January 5, 2026

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

April 29, 2024

Last Update Submit

December 30, 2025

Conditions

Keywords

elderoral hygienelong-term care facility

Outcome Measures

Primary Outcomes (10)

  • Oral Health Assessment Tool

    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.

    Baseline to 4 weeks

  • Oral Health Impact Profile

    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.

    Baseline to 4 weeks

  • Geriatric Oral Health Assessment Index

    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.

    Baseline to 4 weeks

  • Tongue Coating Index

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

    Baseline to 4 weeks

  • Plaque Index

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

    Baseline to 4 weeks

  • Gingival Index

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

    Baseline to 4 weeks

  • Gingival Bleeding Index

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

    Baseline to 4 weeks

  • Eating Assessment Tool

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

    Baseline to 4 weeks

  • Function Oral lntake Scale

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

    Baseline to 4 weeks

  • International Dysphagia Diet Standardisation Initiative

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

    Baseline to 4 weeks

Study Arms (2)

Electric toothbrush

EXPERIMENTAL

Teach Bass brushing technique and use electric toothbrush

Behavioral: Electric toothbrush

Soft bristle toothbrush

ACTIVE COMPARATOR

Teach Bass brushing technique and use soft bristle toothbrush

Behavioral: Soft bristle toothbrush

Interventions

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

Electric toothbrush

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

Soft bristle toothbrush

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eating by mouth
  • Able to express fluently in Chinese after correcting vision and hearing
  • Normal hand functions
  • Able to follow instructions
  • Willing to participate in the study and sign the informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardinal Tien Hospital

New Taipei City, Xindian Dist, 231403, Taiwan

Location

Study Officials

  • En-Chi Chiu, PhD

    National Taipei University of Nursing and Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

September 16, 2024

Primary Completion

December 16, 2024

Study Completion

December 16, 2024

Last Updated

January 5, 2026

Record last verified: 2024-09

Locations