"Safeguard Your Smile" an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 5, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 2, 2016
September 1, 2015
3 months
August 5, 2015
March 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Oral health literacy measured using TS-REALD (Two Stage Rapid Estimate of Adult Literacy in Dentistry)
Three months
Study Arms (2)
Intervention group
EXPERIMENTALSafeguard Your Smile an oral health literacy intervention.
Control group
NO INTERVENTIONNo intervention, only a conventional pamphlet will be given.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Punjabi immigrants who are Montreal residents
- Be in good general health
- Will give written informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dental medicine
Montreal, Quebec, H3C3J7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Canada Research Chair (950-228295), Institut de recherche en Santé Publique and the Centre de Recherche Léa-Roback, School of Public Health
Study Record Dates
First Submitted
August 5, 2015
First Posted
August 13, 2015
Study Start
July 1, 2015
Primary Completion
October 1, 2015
Study Completion
February 1, 2016
Last Updated
March 2, 2016
Record last verified: 2015-09