CariesNCT05212142
A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia
A study testing verbal education and verbal education, visual aids, and motivational interviewing in people with Caries, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a preventive strategy in increasing return to follow up and recall appointments. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Caries
- What is being tested?
- verbal education and verbal education, visual aids, and motivational interviewing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2022to 15 Apr 2023
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- parent with child (patient) planned for dental treatment with general anesthesia (GA)
- parent of a child (patient) age less than six
- parent of a child (patient) with health status of healthy (American Society of Anesthesiologists (ASA) I or II).
Who cannot join
- parents/guardians who chose not to participate in the study
- parents who spoke a language other than English or Spanish
- Parents of a child (patient) with special health care needs or patients of ASA III or IV status
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia: a Randomized Controlled Trial
The purpose of this study is to evaluate the effectiveness of a preventive strategy in increasing return to follow up and recall appointments.
- Conditions
- Caries
- Being tested
- verbal education, verbal education, visual aids, and motivational interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
verbal educationBehavioural
Participants will receive oral health anticipatory guidance in the form of verbal and written education alongside the same preventive follow up and recall appointment schedule.
verbal education, visual aids, and motivational interviewingBehavioural
Participants will receive oral health anticipatory guidance through a combination preventive strategy using motivational interviewing, individualized goal setting, visual aids, and verbal education alongside a preventive follow up and recall appointment schedule
| Study group | Role | What they receive |
|---|---|---|
| Traditional intervention: verbal education | Sham comparator | Not described Receives: Behavioral: verbal education |
| New intervention: verbal education, visual aids, and motivational interviewing | Experimental | Not described Receives: Behavioral: verbal education, visual aids, and motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in parental self-efficacy (PSE)
The PSE questionnaire adapted from an combination of questions developed by Dumka et al. and Johnston \& Mash will measure parents perceived self-efficacy in controlling their child's oral health.
Measured: Baseline to 2 weeks
Change in parent oral health knowledge
A questionnaire developed by Alsada et al. will be adapted and used to test parent's knowledge of overall oral health.
Measured: Baseline to 2 weeks
Follow up return rate
Number of participants who return for follow up in 1 - 2 weeks.
Measured: 2 weeks
3-month recall return rate
Number of participants who return for follow up in 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start10 Jun 2022
- Primary completion30 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayakumar Jayaraman, DDS, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212142
- Sponsor's protocol ID
- HM20023677
- Status last verified
- Aug 2023
- First submitted
- 25 Jan 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05212142
- Acronym / sponsor ID
- HM20023677
- Conditions
- Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- 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 this study is to evaluate the effectiveness of a preventive strategy in increasing return to follow up and recall appointments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional intervention: verbal education | Sham comparator | Behavioral: verbal education |
| New intervention: verbal education, visual aids, and motivational interviewing | Experimental | Behavioral: verbal education, visual aids, and motivational interviewing |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parent with child (patient) planned for dental treatment with general anesthesia (GA)
- parent of a child (patient) age less than six
- parent of a child (patient) with health status of healthy (American Society of Anesthesiologists (ASA) I or II).
Key exclusion criteria (3 listed)
- parents/guardians who chose not to participate in the study
- parents who spoke a language other than English or Spanish
- Parents of a child (patient) with special health care needs or patients of ASA III or IV status
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 |
|---|---|---|
| verbal educationParticipants will receive oral health anticipatory guidance in the form of verbal and written education alongside the same preventive follow up and recall appointment schedule. | Behavioural | Traditional intervention: verbal education |
| verbal education, visual aids, and motivational interviewingParticipants will receive oral health anticipatory guidance through a combination preventive strategy using motivational interviewing, individualized goal setting, visual aids, and verbal education alongside a preventive follow up and recall appointment schedule | Behavioural | New intervention: verbal education, visual aids, and motivational interviewing |
Primary outcome
Change in parental self-efficacy (PSE)
Time frame: Baseline to 2 weeks
The PSE questionnaire adapted from an combination of questions developed by Dumka et al. and Johnston \& Mash will measure parents perceived self-efficacy in controlling their child's oral health.
Change in parent oral health knowledge
Time frame: Baseline to 2 weeks
A questionnaire developed by Alsada et al. will be adapted and used to test parent's knowledge of overall oral health.
Follow up return rate
Time frame: 2 weeks
Number of participants who return for follow up in 1 - 2 weeks.
3-month recall return rate
Time frame: 3 months
Number of participants who return for follow up in 3 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 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Jayakumar Jayaraman, DDS principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing verbal education and verbal education, visual aids, and motivational interviewing in people with Caries, run by Virginia Commonwealth University 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 3 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 2023. 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. Some participants in this study may receive a placebo. 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?
Change in parental self-efficacy (PSE) (time frame: Baseline to 2 weeks). 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 2023.