Oral Health Promotion Program for Persons With Severe Mental Illness

NCT04464941 | Completed DMC

• 1 other identifier: RD103035018
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Evaluate the Effects of an Oral Health Promotion Program

Keywords

oral health, promotion program, plaque index, mental illness

Outcome Measures

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.

  12-week

Study Arms (2)

oral health promotion program

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

Interventions

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

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

oral health promotion program

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted in chronic psychiatric wards were eligible.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Bing Show Chwan Memorial Hospital: lead

Related Publications (1)

• 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.

  PMID: 33109148 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment of dental plaque was carried out by a single dentist, who was blind to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: Cluster Randomized Controlled Study

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 9, 2020
• Study Start: March 21, 2016
• Primary Completion: June 30, 2016
• Study Completion: July 10, 2016
• Last Updated: July 9, 2020

Record last verified: 2020-07