Clinical trial NCT02521155: "Safeguard Your Smile" an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior
Official title: "Safeguard Your Smile" an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior Among Punjabi Immigrants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Dental Plaque
Keywords: Oral health literacy intervention
oral hygiene behavior
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Oral hygiene self-care knowledge using a self administered questionnaire
timeFrame: Three months
measure: Oral hygiene self-care behavior using a self administered questionnaire
timeFrame: Three months
measure: Gingival index
timeFrame: Three months
measure: Dental plaque index
timeFrame: Three months
Secondary outcomes:
measure: Oral health literacy measured using TS-REALD (Two Stage Rapid Estimate of Adult Literacy in Dentistry)
timeFrame: Three months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Faculty of Dental medicine
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Louise Potvin, BA MSc. PhD
role: STUDY_DIRECTOR
affiliation: Université de Montréal
name: Daniel P. Kandelman, DrCD DMD MPH
role: STUDY_DIRECTOR
affiliation: Université de Montréal
name: Navdeep Kaur, BDS MSc.
role: PRINCIPAL_INVESTIGATOR
References: