Back to resultsOral Health Promotion Program for Persons With Severe Mental Illness
Primary Purpose
Evaluate the Effects of an Oral Health Promotion Program
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
a composite intervention with both group and individual components for oral health promotion program
Sponsored by
About this trial
This is an interventional prevention trial for Evaluate the Effects of an Oral Health Promotion Program focused on measuring oral health, promotion program, plaque index, mental illness
Eligibility Criteria
Inclusion Criteria:
- Patients admitted in chronic psychiatric wards were eligible.
Exclusion Criteria:
- significant cognitive disabilities, severe hearing impairment, orthodontic appliances, an edentulous status, or a handicap when tooth-brushing
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
oral health promotion program
Usual care group
Arm Description
The oral health promotion program was a composite intervention with both group and individual components. The group intervention consisted of: 1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included: 1. Instruction in the Bass tooth-brushing method 2. Individual behavioral modification method
Outcomes
Primary Outcome Measures
Dental Plaque Index
Plaque Control Index (PCI) developed by O'Leary et al. to score the primary outcome, plaque accumulation, on the surfaces of the teeth. The score was computed by the existence of plaque divided by all examined surfaces; a higher plaque index indicated poor oral hygiene. We calculated a person-level plaque score by averaging plaque scores for all teeth at each examination.
Secondary Outcome Measures
Full Information
NCT ID
NCT04464941
First Posted
July 7, 2020
Last Updated
July 7, 2020
Sponsor
Chang Bing Show Chwan Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04464941
Brief Title
Oral Health Promotion Program for Persons With Severe Mental Illness
Official Title
Oral Health Promotion Program for Persons With Severe Mental Illness: A Cluster Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
July 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Bing Show Chwan Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A cluster randomized controlled study was carried out in chronic psychiatric wards of a general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards were randomly assigned to an experimental and a control group. Participants in the experimental group underwent an oral health promotion program that consisted of biweekly group education sessions, and a 12-week individual behavioral modification for oral hygiene course. The participants in the control group received usual care only. Dental plaque (measured by the Plaque Control Index) was examined by a single dentist before and after the experiment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluate the Effects of an Oral Health Promotion Program
Keywords
oral health, promotion program, plaque index, mental illness
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster Randomized Controlled Study
Masking
Outcomes Assessor
Masking Description
Assessment of dental plaque was carried out by a single dentist, who was blind to group assignment.
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral health promotion program
Arm Type
Experimental
Arm Description
The oral health promotion program was a composite intervention with both group and individual components. The group intervention consisted of:
1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:
1. Instruction in the Bass tooth-brushing method 2. Individual behavioral modification method
Arm Title
Usual care group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
a composite intervention with both group and individual components for oral health promotion program
Intervention Description
The group intervention consisted of:
1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:
1. Instruction in the Bass tooth-brushing method, 2. Individual behavioral modification method
Primary Outcome Measure Information:
Title
Dental Plaque Index
Description
Plaque Control Index (PCI) developed by O'Leary et al. to score the primary outcome, plaque accumulation, on the surfaces of the teeth. The score was computed by the existence of plaque divided by all examined surfaces; a higher plaque index indicated poor oral hygiene. We calculated a person-level plaque score by averaging plaque scores for all teeth at each examination.
Time Frame
12-week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted in chronic psychiatric wards were eligible.
Exclusion Criteria:
significant cognitive disabilities, severe hearing impairment, orthodontic appliances, an edentulous status, or a handicap when tooth-brushing
12. IPD Sharing Statement
Citations:
PubMed Identifier
33109148
Citation
Kuo MW, Yeh SH, Chang HM, Teng PR. Effectiveness of oral health promotion program for persons with severe mental illness: a cluster randomized controlled study. BMC Oral Health. 2020 Oct 27;20(1):290. doi: 10.1186/s12903-020-01280-7.
Results Reference
derived
Learn more about this trial
Oral Health Promotion Program for Persons With Severe Mental Illness
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