Evaluate the Effects of an Oral Health Promotion ProgramNCT04464941

Oral Health Promotion Program for Persons With Severe Mental Illness

A study testing a composite intervention with both group and individual components for oral health promotion program in people with Evaluate the Effects of an Oral Health Promotion Program, run by Chang Bing Show Chwan Memorial Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 65 years, men only
Conditions the study is for: Evaluate the Effects of an Oral Health Promotion Program
What is being tested?: a composite intervention with both group and individual components for oral health promotion program
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: No sites listed yet
Study dates: 21 Mar 2016to 10 Jul 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients admitted in chronic psychiatric wards were eligible.

Who cannot join

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

About this study

Official title: 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.

Conditions: Evaluate the Effects of an Oral Health Promotion Program
Being tested: a composite intervention with both group and individual components for oral health promotion program
Keywords: oral health, promotion program, plaque index, mental illness
Medical subject headings: Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

a composite intervention with both group and individual components for oral health promotion programBehavioural
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:
2. Instruction in the Bass tooth-brushing method, 2. Individual behavioral modification method

Study groups in NCT04464941
Study group	Role	What they receive
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 Receives: Behavioral: a composite intervention with both group and individual components for oral health promotion program
Usual care group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 201610 Jul 2016

First posted9 Jul 2020
Study start21 Mar 2016
Primary completion30 Jun 2016
Study completion10 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Evaluate the Effects of an Oral Health Promotion ProgramStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Cluster Randomized Controlled Study
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04464941
Sponsor's protocol ID: RD103035018
Status last verified: Jul 2020
First submitted: 7 Jul 2020
Last updated: 9 Jul 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 33109148

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Health Promotion Program for Persons With Severe Mental Illness: A Cluster Randomized Controlled Study
ClinicalTrials.gov ID: NCT04464941
Acronym / sponsor ID: RD103035018
Conditions: Evaluate the Effects of an Oral Health Promotion Program
Keywords: oral health, promotion program, plaque index, mental illness
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Chang Bing Show Chwan Memorial HospitalUniversity, hospital or other
Study start: 21 Mar 2016 (actual)
Primary completion: 30 Jun 2016 (actual)
Study completion: 10 Jul 2016 (actual)
First posted: 9 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Cluster Randomized Controlled Study

Arm	Type	Receives
oral health promotion program	Experimental	Behavioral: a composite intervention with both group and individual components for oral health promotion programThe 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
Usual care group	No intervention	–

Who may qualify

Ages: 20 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients admitted in chronic psychiatric wards were eligible.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
a composite intervention with both group and individual components for oral health promotion programThe 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	Behavioural	oral health promotion program

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
Derived from this study: PubMed 33109148Kuo 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dental Plaque Index (time frame: 12-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04464941, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.