Preventive Oral HealthNCT00846066
Oral Health Training Program for Pediatric Residents
A study testing Hands on training and Web based training in people with Preventive Oral Health, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study was to compare the effect of the addition of hands on training by a pediatric dentist on the pediatric residents skills, confidence, opinions and practice related to preventive oral health. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Preventive Oral Health
- What is being tested?
- Hands on training and Web based training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pediatric Residents in the Continuity Care Clinics at Children's Mercy Hospital during the months of January and February 2007
Who cannot join
- Residents on leave of absence
- Residents who have their Continuity Care Clinics off site
- Residents refusing consent for inclusion of results in study
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Effective Educational Instruction in Preventive Oral Health: Hands On Training (HOT)Versus Web Based Training (WBT): A Randomized Control Trial
The purpose of this study was to compare the effect of the addition of hands on training by a pediatric dentist on the pediatric residents skills, confidence, opinions and practice related to preventive oral health.
Read the detailed description
Objectives:
To compare the addition of Hands on Training (HOT) to Web Based Training (WBT)on residents' skills, confidence, opinions and practice .
Methods: Pediatric residents participated in WBT on preventive oral health. Then the WBT subjects were randomly assigned to receive HOT by a dentist, or WBT alone. All subjects were assessed on skills in the performance of an oral exam, by direct observation. Residents' confidence regarding oral health counseling, and their opinions about the importance of the incorporation of oral health into the well child visit, was measured by surveys utilizing a Likert scale. Residents' change in practice was assessed by a retrospective chart audit.
- Conditions
- Preventive Oral Health
- Being tested
- Hands on training, Web based training
- Keywords
- educational research,, instructional methods,, Hands on training,, Web based training,, pediatric residents, preventive oral health,, dental caries,, Instructional strategies in Preventive Oral health, Web-based training on Preventive Oral Health, Hands on Training on Preventive Oral Health
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands on trainingOther
Also called Active educational training with a pediatric dentist
Hands on training by a pediatric dentist on preventive oral health
Web based trainingOther
Also called Educational Web Based Training for all residents
Web based training alone
| Study group | Role | What they receive |
|---|---|---|
| Hands on Training | Experimental | Hands on Training by a pediatric dentist Receives: Other: Hands on training; Other: Web based training |
| Web Based Training | Active comparator | Web Based Training for all residents before randomization Receives: Other: Web based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percentage of Correct Skills
Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups
Measured: 3 months after Hands-on Training (HOT)
Percent Change From Baseline in Confidence at 4 Months
Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of "very confident" was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%
Measured: Baseline and 4 months
Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months
Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the "agree" and "strongly agree" responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%
Measured: Baseline and 4 months
Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months
The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}*100%
Measured: At baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preventive Oral HealthStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasreen Talib, Children's Mercy Hospital Kansas City
- Investigators
- Nasreen J Talib, MD,MPH, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846066
- Sponsor's protocol ID
- IRB# 06 10-150E
- Status last verified
- Jul 2015
- First submitted
- 13 Feb 2009
- Last updated
- 14 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Educational Instruction in Preventive Oral Health: Hands On Training (HOT)Versus Web Based Training (WBT): A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00846066
- Acronym / sponsor ID
- IRB# 06 10-150E
- Conditions
- Preventive Oral Health
- Keywords
- educational research,, instructional methods,, Hands on training,, Web based training,, pediatric residents, preventive oral health,, dental caries,, Instructional strategies in Preventive Oral health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 22 Oct 2009
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 this study was to compare the effect of the addition of hands on training by a pediatric dentist on the pediatric residents skills, confidence, opinions and practice related to preventive oral health.
Detailed description
Objectives:
To compare the addition of Hands on Training (HOT) to Web Based Training (WBT)on residents' skills, confidence, opinions and practice .
Methods: Pediatric residents participated in WBT on preventive oral health. Then the WBT subjects were randomly assigned to receive HOT by a dentist, or WBT alone. All subjects were assessed on skills in the performance of an oral exam, by direct observation. Residents' confidence regarding oral health counseling, and their opinions about the importance of the incorporation of oral health into the well child visit, was measured by surveys utilizing a Likert scale. Residents' change in practice was assessed by a retrospective chart audit.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hands on Training | Experimental | Other: Hands on training, Other: Web based trainingHands on Training by a pediatric dentist |
| Web Based Training | Active comparator | Other: Web based trainingWeb Based Training for all residents before randomization |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pediatric Residents in the Continuity Care Clinics at Children's Mercy Hospital during the months of January and February 2007
Key exclusion criteria (3 listed)
- Residents on leave of absence
- Residents who have their Continuity Care Clinics off site
- Residents refusing consent for inclusion of results in study
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 |
|---|---|---|
| Hands on trainingAlso: Active educational training with a pediatric dentistHands on training by a pediatric dentist on preventive oral health | Other | Hands on Training |
| Web based trainingAlso: Educational Web Based Training for all residentsWeb based training alone | Other | Hands on Training, Web Based Training |
Primary outcome
Mean Percentage of Correct Skills
Time frame: 3 months after Hands-on Training (HOT)
Skills were observed by pediatric dentists for each resident utilizing a six item checklist 3 months after the intervention (HOT) was completed.Each correct skill demonstrated was scored as 1 (16.67%) with a maximum of 6 representing 100%.The mean pecentage of correct skills were measured by direct observation by a pediatric dentist among the WBT alone and WBT+HOT groups
Percent Change From Baseline in Confidence at 4 Months
Time frame: Baseline and 4 months
Confidence was measured by self-administered surveys regarding knowledge and practice of oral health. The surveys used a 4 point Likert scale (1=not confident, 4=very confident).The mean percent of change in the responses of "very confident" was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%
Percent Change From Baseline in Opinions Regarding Incorporating Oral Health Into a Well Child Visit at 4 Months
Time frame: Baseline and 4 months
Opinions regarding incorporating oral health into a well child visit was measured by self administered surveys. The surveys used a 4 point Likert scale from 1 for (strongly disagree) to 4 for (strongly agree). Mean percentage change in the "agree" and "strongly agree" responses by the residents was compared between both groups. The percentage change equals {(mean score at 4 months-mean score at baseline)/ mean score at baseline} *100%
Percent Change From Baseline in Practice of Oral Health Based on Pre and Post Study Chart Audit at 6 Months
Time frame: At baseline and 6 months
The mean percent change in the documentation of oral health components at a well child visit. This was done by an audit of a random selection of 5 charts of patients who came in for well child visits, completed by each resident at baseline and at 6 months later.We scored this utilizing a 4 item checklist each correct item was scored as 1 (25%), with a maximum of 4(100%). The percentage change used the following formula {(mean score at 6 months-mean score at baseline)/mean score at baseline}*100%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nasreen J Talib, MD,MPH principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hands on training and Web based training in people with Preventive Oral Health, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 1 inclusion and 3 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 14 Aug 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Percentage of Correct Skills (time frame: 3 months after Hands-on Training (HOT)). 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 14 Aug 2015.