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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Oral Hygiene; Oral Health Care
• Intervention / Treatment: Behavioral: Oral Health Care Program

Detailed Description

This study employed a quasi-experimental design to examine the effects of an oral health care program on oral hygiene and oral function among older adults with dementia attending a day care center. Participants received a structured oral health care intervention designed to promote oral hygiene practices and oral functional ability. Outcome measures related to oral hygiene and oral function were assessed at baseline and at 4 weeks after the intervention. This study aimed to provide evidence on the effectiveness of an oral health care program for improving oral health outcomes in older adults with dementia in a day care setting.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hualien County
    • Hualien City, Hualien County, Taiwan, 974
      • Mennonite Christian Hospital Shoufeng Branch Day Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Health Care Program; 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; 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.
No Intervention: Usual Care (Waiting-list Control); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	Dental plaque accumulation was assessed using the Plaque Index, which evaluates the thickness of dental plaque at the gingival area. Scores range from 0 to 3, with higher scores indicating greater plaque accumulation and poorer oral hygiene.	From baseline to 4 weeks after intervention
Tongue coating index	Tongue coating was assessed using the Tongue Coating Index, with scores ranging from 0 to 2. A lower score indicates less tongue coating and better oral hygiene.	From baseline to 4 weeks after intervention.
Puff cheeks	The ability to puff the cheeks was assessed using a functional scoring scale ranging from 0 to 5, where 0 indicates inability to puff the cheeks, 3 indicates barely able to puff the cheeks, and 5 indicates the ability to puff both cheeks. Higher scores indicate better oral function.	From baseline to 4 weeks after intervention.
Choke	Swallowing ability was assessed using a choking frequency scale ranging from 0 to 5, where 0 indicates tube feeding, 1 indicates frequent choking, 3 indicates occasional choking, and 5 indicates almost no choking. Higher scores indicate better swallowing function.	From baseline to 4 weeks after intervention.
Repetitive Saliva Swallowing Test (RSST)	Have the subject sit. The examiner gently places their fingertip on the subject's Adam's apple or hyoid bone and instructs the subject to swallow saliva. The examiner can feel the Adam's apple rise and then return to its original position. If the subject experiences dry mouth, about 1 cc of water can be given. Observe this action for 30 seconds and record the number of swallows obtained through palpation.The Repetitive Saliva Swallowing Test (RSST) was used to assess swallowing function by counting the number of saliva swallows within 30 seconds. Higher values indicate better swallowing ability.	From baseline to 4 weeks after intervention.
Oral DDK rate(times/10')	Oral diadochokinetic (DDK) rate was assessed by counting the number of syllable repetitions produced within 10 seconds. Higher values indicate better oral motor function.	From baseline to 4 weeks after intervention.

Collaborators and Investigators

• Sponsor: Shiou-fang Lu

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Actual): October 21, 2023
• Study Completion (Actual): October 21, 2023

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dementia; Oral hygiene; Older adults; oral function; Day care center; oral care intervention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: IRB23-01-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No