The Effect of Oral Health Care Program on Oral Hygiene and Oral Function for the Elderly Patient With Dementia in Day Care Center

NCT07401693 | Completed

• 1 other identifier: IRB23-01-003
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the effects of an oral health care program on oral hygiene and oral function in older adults with dementia attending a day care center. Participants received a structured oral health care intervention, and changes in oral hygiene and oral function were assessed over a 4-week follow-up period. The goal of this study was to explore whether a structured oral health care program could help improve oral health outcomes in older adults with dementia in a day care setting.

Conditions

Dementia; Oral Health Care; Oral Hygiene

Keywords

Dementia; Oral hygiene; Day care center; Older adults; oral care intervention; oral function

Outcome Measures

Primary Outcomes (2)

• Oral hygiene

  Oral hygiene was assessed using the Oral Health Assessment Tool (OHAT) as the primary outcome measure. OHAT is a validated composite scale with a total score ranging from 0 to 16, with higher total scores indicating poorer oral health status.

  From baseline to 4 weeks after intervention

• Oral function

  Oral function was assessed using standardized functional assessments to evaluate changes in oral motor and swallowing function following the oral care intervention. Higher scores or values indicate better oral or swallowing function.

  From baseline to 4 weeks after intervention

Secondary Outcomes (6)

• Plaque index

  From baseline to 4 weeks after intervention

• Tongue coating index

  From baseline to 4 weeks after intervention.

• Puff cheeks

  From baseline to 4 weeks after intervention.

• Choke

  From baseline to 4 weeks after intervention.

• Repetitive Saliva Swallowing Test (RSST)

  From baseline to 4 weeks after intervention.

Study Arms (2)

Oral Health Care Program

EXPERIMENTAL

Participants assigned to the intervention group received a structured oral health care program designed to improve oral hygiene and oral function. Outcome measures were assessed at baseline and at 4 weeks after the intervention.

Behavioral: Oral Health Care Program

Usual Care (Waiting-list Control)

NO INTERVENTION

Participants assigned to the control (waiting-list) group did not receive the oral health care intervention during the study period and continued with usual care. Outcome measures were assessed at baseline and at 4 weeks.

Interventions

Oral Health Care Program BEHAVIORAL

A structured oral health care program designed to improve oral hygiene and oral function among older adults with dementia attending a day care center. The program included guided oral exercises and daily oral hygiene practices delivered over a 4-week period.

Oral Health Care Program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 60 years or older.
• Diagnosed with dementia by a physician.
• Attending a day care center.
• Able to participate in the oral health care program and assessments.
• Provided informed consent from the participant or a legally authorized representative

You may not qualify if:

• Presence of acute medical conditions that would interfere with participation.
• Severe physical or mental conditions that prevent completion of the intervention or outcome assessments.
• Refusal or inability to provide informed consent.

Sponsors & Collaborators

• Shiou-fang Lu: lead

Study Sites (1)

Mennonite Christian Hospital Shoufeng Branch Day Care Center

Hualien City, Hualien County, 974, Taiwan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were assigned to either an intervention group or a control (waiting-list) group. The intervention group received the oral health care program, while the control group did not receive the intervention during the study period. Outcomes were assessed at baseline and at 4 weeks after the intervention.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 10, 2026
• Study Start: July 20, 2023
• Primary Completion: October 21, 2023
• Study Completion: October 21, 2023
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)