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

Primary Purpose

Gingivitis, Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Safeguard Your Smile an oral health literacy intervention
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring Oral health literacy intervention, oral hygiene behavior

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dental medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Safeguard Your Smile an oral health literacy intervention.

No intervention, only a conventional pamphlet will be given.

Outcomes

Primary Outcome Measures

Oral hygiene self-care knowledge using a self administered questionnaire
Using a self administered questionnaire
Oral hygiene self-care behavior using a self administered questionnaire
Using a self administered questionnaire
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 5, 2015
Last Updated
March 1, 2016
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02521155
Brief Title
"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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Dental Plaque
Keywords
Oral health literacy intervention, oral hygiene behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Safeguard Your Smile an oral health literacy intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention, only a conventional pamphlet will be given.
Intervention Type
Behavioral
Intervention Name(s)
Safeguard Your Smile an oral health literacy intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oral hygiene self-care knowledge using a self administered questionnaire
Description
Using a self administered questionnaire
Time Frame
Three months
Title
Oral hygiene self-care behavior using a self administered questionnaire
Description
Using a self administered questionnaire
Time Frame
Three months
Title
Gingival index
Description
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.
Time Frame
Three months
Title
Dental plaque index
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Oral health literacy measured using TS-REALD (Two Stage Rapid Estimate of Adult Literacy in Dentistry)
Description
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.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Potvin, BA MSc. PhD
Organizational Affiliation
Université de Montréal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel P. Kandelman, DrCD DMD MPH
Organizational Affiliation
Université de Montréal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Navdeep Kaur, BDS MSc.
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dental medicine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3C3J7
Country
Canada

12. IPD Sharing Statement

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

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