GingivitisNCT02521155
"Safeguard Your Smile" an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior
A study testing Safeguard Your Smile an oral health literacy intervention in people with Gingivitis and Dental Plaque, run by Université de Montréal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque
- What is being tested?
- Safeguard Your Smile an oral health literacy intervention
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Punjabi immigrants who are Montreal residents
- Be in good general health
- Will give written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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.
- Conditions
- Gingivitis, Dental Plaque
- Being tested
- Safeguard Your Smile an oral health literacy intervention
- Keywords
- Oral health literacy intervention, oral hygiene behavior
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safeguard Your Smile an oral health literacy interventionBehavioural
Safeguard Your Smile intervention will consist of following five components:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Safeguard Your Smile an oral health literacy intervention. Receives: Behavioral: Safeguard Your Smile an oral health literacy intervention |
| Control group | No intervention | No intervention, only a conventional pamphlet will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral hygiene self-care knowledge using a self administered questionnaire
Using a self administered questionnaire
Measured: Three months
Oral hygiene self-care behavior using a self administered questionnaire
Using a self administered questionnaire
Measured: 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.
Measured: 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.
Measured: Three months
Secondary outcomes (1)
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Potvin, Université de Montréal
- Investigators
- Louise Potvin, BA MSc. PhD, Study director, Université de MontréalDaniel P. Kandelman, DrCD DMD MPH, Study director, Université de MontréalNavdeep Kaur, BDS MSc., Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521155
- Sponsor's protocol ID
- 15-071-CERES-D
- Status last verified
- Sep 2015
- First submitted
- 5 Aug 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Safeguard Your Smile" an Oral Health Literacy Intervention Promoting Positive Oral Hygiene Self-care Behavior Among Punjabi Immigrants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02521155
- Acronym / sponsor ID
- 15-071-CERES-D
- Conditions
- Gingivitis, Dental Plaque
- Keywords
- Oral health literacy intervention, oral hygiene behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Safeguard Your Smile an oral health literacy interventionSafeguard Your Smile an oral health literacy intervention. |
| Control group | No intervention | –No intervention, only a conventional pamphlet will be given. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Punjabi immigrants who are Montreal residents
- Be in good general health
- Will give written informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safeguard Your Smile an oral health literacy interventionSafeguard 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. | Behavioural | Intervention group |
Primary outcome
Oral hygiene self-care knowledge using a self administered questionnaire
Time frame: Three months
Using a self administered questionnaire
Oral hygiene self-care behavior using a self administered questionnaire
Time frame: Three months
Using a self administered questionnaire
Gingival index
Time frame: Three months
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
Time frame: Three months
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.
1 secondary outcome
Oral health literacy measured using TS-REALD (Two Stage Rapid Estimate of Adult Literacy in Dentistry)
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Potvin, BA MSc. PhD study director
Université de Montréal
Daniel P. Kandelman, DrCD DMD MPH study director
Université de Montréal
Navdeep Kaur, BDS MSc. principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safeguard Your Smile an oral health literacy intervention in people with Gingivitis and Dental Plaque, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral hygiene self-care knowledge using a self administered questionnaire (time frame: Three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.