NCT02521155

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

August 5, 2015

Last Update Submit

March 1, 2016

Conditions

Keywords

Oral health literacy interventionoral hygiene behavior

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

EXPERIMENTAL

Safeguard Your Smile an oral health literacy intervention.

Behavioral: Safeguard Your Smile an oral health literacy intervention

Control group

NO INTERVENTION

No 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.

Intervention group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

GingivitisDental Plaque

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Officials

  • Louise Potvin, BA MSc. PhD

    Université de Montréal

    STUDY DIRECTOR
  • Daniel P. Kandelman, DrCD DMD MPH

    Université de Montréal

    STUDY DIRECTOR
  • Navdeep Kaur, BDS MSc.

    Université de Montréal

    PRINCIPAL INVESTIGATOR

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

Locations