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

"Safeguard Your Smile" an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior Among Punjabi Immigrants: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis; Dental Plaque
• Intervention / Treatment: Behavioral: Safeguard Your Smile an oral health literacy intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3C3J7
      • Faculty of dental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Safeguard Your Smile an oral health literacy intervention.	Behavioral: 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.
No Intervention: Control group; No intervention, only a conventional pamphlet will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral hygiene self-care knowledge using a self administered questionnaire	Using a self administered questionnaire	Three months
Oral hygiene self-care behavior using a self administered questionnaire	Using a self administered questionnaire	Three months
Gingival index	Loe and Sillness gingival index scores to assess gingivitis, score 0=no gingival inflammation, 1=mild inflammation-slight change in colour of gingiva, 2=moderate inflammation-moderate glazing, redness, edema and hypertrophy, tendency to bleed, score 3=severe inflammation, marked redness and hypertrophy, tendency to spontaneous bleeding.	Three months
Dental plaque index	Loe and Sillness plaque index on the six Ramfjord teeth (16, 12, 24, 36, 32, 44 on proximal, buccal and lingual sides). Score 0= no dental plaque seen in the gingival area; score 1= dental plaque present on the free gingival margin; score 2= moderate accumulation of dental plaque at the gingival margin seen by naked eye and score 3= abundant dental plaque in the gingival margin.	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health literacy measured using TS-REALD (Two Stage Rapid Estimate of Adult Literacy in Dentistry)	Participant's oral health literacy levels will be measured using validated oral health literacy measurement instrument i.e. TS-REALD (Two Stage Rapid Estimate of Adult Literacy in Dentistry). TS-REALD is a word recognition routing test in which participants are asked to read a list of 5 dental words aloud and one point is given for the correct answer. This first stage of the test categorizes the participants depending on their scores into three groups of stage 2 for further testing: i) low literacy stage-2 (4 words test); ii) average literacy stage-2 (6 words test); and high literacy stage-2 ( 3 words test).The score from routing test is added to stage-2 score and this is called raw score. This raw score is translated into a scaled score by using the scaled score translational table that had been derived using psychometric testing. Specific cut offs for high and low oral health literacy are determined using the mean and the standard deviation of the scaled scores.	Three months

Collaborators and Investigators

• Sponsor: Université de Montréal
• Investigators: Study Director: Louise Potvin, BA MSc. PhD, Université de Montréal; Study Director: Daniel P. Kandelman, DrCD DMD MPH, Université de Montréal; Principal Investigator: Navdeep Kaur, BDS MSc., Université de Montréal

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Oral health literacy intervention; oral hygiene behavior
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Tooth Diseases; Dental Deposits; Gingivitis; Dental Plaque; Anti-Infective Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Fenbendazole
• Other Study ID Numbers: 15-071-CERES-D