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Completed

NCT Number: NCT04464941

Oral Health Promotion Program for Persons With Severe Mental Illness

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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Key information

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

The group intervention consisted of:

  • Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:
  • Instruction in the Bass tooth-brushing method, 2. Individual behavioral modification method

Primary outcomes

  1. Dental Plaque Index

    Time frame: 12-week

    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.

Sponsors and collaborators

Lead sponsor

Chang Bing Show Chwan Memorial Hospital

Other

Registry information

Official study title

Oral Health Promotion Program for Persons With Severe Mental Illness: A Cluster Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2020
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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