Oral Health Promotion Program for Persons With Severe Mental Illness

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
No Intervention: Usual care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-week

Collaborators and Investigators

• Sponsor: Chang Bing Show Chwan Memorial Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2016
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): July 10, 2016

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: oral health, promotion program, plaque index, mental illness
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: RD103035018

Drug and device information, study documents

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