Oral Health Promotion Program for Persons With Severe Mental Illness

Not Applicable

Completed

• Conditions: Evaluate the Effects of an Oral Health Promotion Program
• Interventions: Behavioral: a composite intervention with both group and individual components for oral health promotion program

• Registration Number: NCT04464941
• Lead Sponsor: Chang Bing Show Chwan Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-21
• Primary Completion: 2016-06-30
• Study Completion: 2016-07-10
• Status Verified: 2020-07
• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Last Update Submitted: 2020-07-07
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Dental Plaque Index	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.