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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521155
• Other study ID #: 15-071-CERES-D
• Status: Completed
• Phase: N/A
• First received: August 5, 2015
• Last updated: March 1, 2016
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: September 2015
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Plaque
• Gingivitis

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.

Locations

Country	Name	City	State
Canada	Faculty of Dental medicine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral hygiene self-care knowledge using a self administered questionnaire	Using a self administered questionnaire	Three months	No
Primary	Oral hygiene self-care behavior using a self administered questionnaire	Using a self administered questionnaire	Three months	No
Primary	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	No
Primary	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	No
Secondary	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	No