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CompletedNCT04464941Updated Jul 9, 2020

Oral Health Promotion Program for Persons With Severe Mental Illness

An interventional study of a composite intervention with both group and individual components for oral health promotion program in Evaluate the Effects of an Oral Health Promotion Program, sponsored by Chang Bing Show Chwan Memorial Hospital. Completed. Open to male participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-09.

Sponsored by Chang Bing Show Chwan Memorial Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Mar 2016, registered Jul 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Male
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Study 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.

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Conditions studied

  • Evaluate the Effects of an Oral Health Promotion Program

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Keywords

  • oral health, promotion program, plaque index, mental illness
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In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 68 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

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Lead sponsor

Chang Bing Show Chwan Memorial Hospital is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patients admitted in chronic psychiatric wards were eligible.

Exclusion criteria

Exclusion Criteria:

  • significant cognitive disabilities, severe hearing impairment, orthodontic appliances, an edentulous status, or a handicap when tooth-brushing
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    oral health promotion program

    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

    Behavioral: a composite intervention with both group and individual components for oral health promotion program

  • No intervention
    Usual care group

Interventions

  • Behaviorala composite intervention with both group and individual components for oral health promotion program

    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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12-week

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 33109148 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04464941
Lead sponsor
Chang Bing Show Chwan Memorial Hospital
Responsible party
Po-Ren Teng (MD, PhD, Chang Bing Show Chwan Memorial Hospital) — Principal investigator
First posted
Jul 9, 2020
Start date
Mar 21, 2016
Primary completion
Jun 30, 2016
Completion
Jul 10, 2016
Last update
Jul 9, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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