"Safeguard Your Smile" an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior

NCT ID: NCT02521155

Last Updated: 2016-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-02-29

Brief Summary

The purpose of the investigators' study is to assess effectiveness of community based oral health literacy intervention promoting positive oral hygiene self-care behavior among Montreal's Punjabi immigrants.

Detailed Description

There will be 140 participants in this study who will be randomly allocated into either intervention group (70) or control group (70).The intervention group will receive one hour long "Safeguard Your Smile" intervention and control group will receive no intervention and only a conventional pamphlet. Data will be collected at baseline and after 3 months using three research instruments. i) Oral hygiene self-care knowledge and oral hygiene self-care behavior will be assessed using self administered questionnaire. ii) Using Loe and Sillness indices, plaque and gingival index scores will be measured. iii) And oral health literacy of participants will be measured with the TS-REALD tool.The data analysis will include descriptive statistics and frequency tables will be provided for both baseline and endpoint data of the both groups. Continuous variables will be summarized with mean, standard deviation and range and for the categorical variables; frequency counts and percentage of subjects within each category will be provided. An array of data analysis including t-test, correlations and logistic regression will be performed assessing effectiveness of the Safeguard Your Smile intervention.

Conditions

Gingivitis; Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

Safeguard Your Smile an oral health literacy intervention.

Group Type: EXPERIMENTAL

Safeguard Your Smile an oral health literacy intervention

Intervention Type: BEHAVIORAL

Safeguard Your Smile intervention will consist of following five components:

i) Reviewing photonovel (educational booklet) with participants to help them understand adequate oral hygiene self-care behavior. ii) Demonstrating adequate tooth brushing, flossing and tongue cleaning (frequency, duration and technique) on dentoform iii) Helping participants to make a concrete plan (specifying when where and how will they perform oral hygiene self-care behavior and a coping plan). Also, to identify a prompt/cue that would act as a reminder. iv) Assigning a task to participants to daily check-mark their behavioral progress on a calendar provided in the photonovel for the next three months. v) Follow up by making three phone calls to each participant of the intervention group once a month.

Control group

No intervention, only a conventional pamphlet will be given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Safeguard Your Smile an oral health literacy intervention

Safeguard Your Smile intervention will consist of following five components:

i) Reviewing photonovel (educational booklet) with participants to help them understand adequate oral hygiene self-care behavior. ii) Demonstrating adequate tooth brushing, flossing and tongue cleaning (frequency, duration and technique) on dentoform iii) Helping participants to make a concrete plan (specifying when where and how will they perform oral hygiene self-care behavior and a coping plan). Also, to identify a prompt/cue that would act as a reminder. iv) Assigning a task to participants to daily check-mark their behavioral progress on a calendar provided in the photonovel for the next three months. v) Follow up by making three phone calls to each participant of the intervention group once a month.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Punjabi immigrants who are Montreal residents
• Be in good general health
• Will give written informed consent

Exclusion Criteria

• Non permanent residents e.g. refugees
• Presence of orthodontic appliances
• Having any disease of soft/ hard oral tissues e.g. advanced periodontitis
• Having any systemic disease e.g. diabetes
• On certain medications such as phenytoin.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Louise Potvin

Canada Research Chair (950-228295), Institut de recherche en Santé Publique and the Centre de Recherche Léa-Roback, School of Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise Potvin, BA MSc. PhD

Role: STUDY_DIRECTOR

Université de Montréal

Daniel P. Kandelman, DrCD DMD MPH

Role: STUDY_DIRECTOR

Université de Montréal

Navdeep Kaur, BDS MSc.

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

Faculty of Dental medicine

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

15-071-CERES-D

Identifier Type: -

Identifier Source: org_study_id