Oral Health Promotion Program for Persons With Severe Mental Illness

Evaluate the Effects of an Oral Health Promotion Program Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464941
• Other study ID #: RD103035018
• Status: Completed
• Phase: N/A
• Start date: March 21, 2016
• Est. completion date: July 10, 2016

Study information

• Verified date: July 2020
• Source: Chang Bing Show Chwan Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 10, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Evaluate the Effects of an Oral Health Promotion Program
• Mental Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Bing Show Chwan Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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