Dental Caries in ChildrenNCT04101617
Improving Dental Health Among Toddlers in the Dominican Republic
A study testing Oral Health education including printed educational material in people with Dental Caries in Children and Dental Caries, run by Universidad Iberoamericana at 1 site in Dominican Republic.
Trial summary
Caries prevalence in the Dominican Republic (DR) seems high, although recent information is lacking. In DR there is a growth and development program for all children from the age of 0 to 5.Even though there is a mandatory educational health program for children and parents in this program, where periodically… Read more about this study
- Who is it for?
- Ages 10 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Dental Caries
- What is being tested?
- Oral Health education including printed educational material
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteDominican Republic
- Study dates
- 13 Feb 2019to 1 Aug 2021
- 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 10 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children
- Parents agreed to participate in the program
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Hospital General Plaza de la Salud
Santo Domingo, Nacional
About this study
Official title: Cooperation Between Dentists and Pediatricians to Improve Dental Health Among Toddlers in the Dominican Republic
Caries prevalence in the Dominican Republic (DR) seems high, although recent information is lacking. In DR there is a growth and development program for all children from the age of 0 to 5.Even though there is a mandatory educational health program for children and parents in this program, where periodically pediatricians examine them, this program does not include oral health education/prevention. Thus, it is proposed A) to devise materials to be used by pediatricians to share relevant information about caries control to parents of toddlers, and B) to evaluate the impact of such material on caries prevention for groups of toddlers over a 1.5-year period. Educational material will be developed for parents, and the pediatricians will deliver this material to 10-months-old children randomly selected at Plaza de la Salud Hospital. The PI will train the pediatricians in caries prevention and how to deliver the information to the parents in a clear manner. A total of 306 will be allocated into two groups. The experimental group (128 children) will receive the devised educational materials at 10 months, follow-up information will be provided at growth and development visits when the child is 18-, and 24 months old. The second group will be considered as the control group and will not receive any educational materials (178 children). All the enrolled children will receive fluoride containing toothpaste and tooth brushes. After 18 months when the children will be about 3 years old they will be examined to assess dental caries status. A sample mortality rate of 40% is expected during the two-year follow-up. Differences in caries status between the two groups will be examined using Welch's independent t-tests for unequal variances.
- Conditions
- Dental Caries in Children, Dental Caries
- Being tested
- Oral Health education including printed educational material
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health education including printed educational materialBehavioural
Printed and online educational materials were developed and provided to pediatricians so they can share relevant information about caries control to parents of toddlers. A previous interview was performed to pediatricians as focus groups to know how they are doing their evaluations and what do they take into account during the children visits in order to identify where to focus for the training what it is necessary to change. After that pediatricians were trained to give oral health recommendations. So, to the intervention group, the pediatricians will give these recommendations to the parents and also they will give them a printed educational material previously developed for the project.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will receive previously designed educational material with recommendations for healthy habits and oral health recommendations. Also, pediatricians will give the parents oral health education. Parents and their children will receive toothbrushes as well as toothpaste. Receives: Behavioral: Oral Health education including printed educational material |
| Control Group | No intervention | Parents and their children will receive toothbrushes as well as toothpaste. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries status
Detection of dental caries lesions using the International Caries Detection and Assessment System (ICDAS) criteria.
Measured: Up to ten months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start13 Feb 2019
- Primary completion1 Jun 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Iberoamericana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Borrow Foundation, Hospital General Plaza de la Salud, Colgate Palmolive
- Responsible party
- Principal investigator, Ninoska Abreu Placeres, Universidad Iberoamericana
- Investigators
- Kim Ekstrand, PhD, Study director, The University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101617
- Sponsor's protocol ID
- CEI2017-14
- Status last verified
- Dec 2021
- First submitted
- 19 Sep 2019
- Last updated
- 20 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperation Between Dentists and Pediatricians to Improve Dental Health Among Toddlers in the Dominican Republic
- ClinicalTrials.gov ID
- NCT04101617
- Acronym / sponsor ID
- CEI2017-14
- Conditions
- Dental Caries in Children, Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Universidad IberoamericanaUniversity, hospital or other
- Collaborators
- University of Copenhagen, Borrow Foundation, Hospital General Plaza de la Salud, Colgate Palmolive
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 24 Sep 2019 (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.
Caries prevalence in the Dominican Republic (DR) seems high, although recent information is lacking. In DR there is a growth and development program for all children from the age of 0 to 5.Even though there is a mandatory educational health program for children and parents in this program, where periodically pediatricians examine them, this program does not include oral health education/prevention. Thus, it is proposed A) to devise materials to be used by pediatricians to share relevant information about caries control to parents of toddlers, and B) to evaluate the impact of such material on caries prevention for groups of toddlers over a 1.5-year period. Educational material will be developed for parents, and the pediatricians will deliver this material to 10-months-old children randomly selected at Plaza de la Salud Hospital. The PI will train the pediatricians in caries prevention and how to deliver the information to the parents in a clear manner. A total of 306 will be allocated into two groups. The experimental group (128 children) will receive the devised educational materials at 10 months, follow-up information will be provided at growth and development visits when the child is 18-, and 24 months old. The second group will be considered as the control group and will not receive any educational materials (178 children). All the enrolled children will receive fluoride containing toothpaste and tooth brushes. After 18 months when the children will be about 3 years old they will be examined to assess dental caries status. A sample mortality rate of 40% is expected during the two-year follow-up. Differences in caries status between the two groups will be examined using Welch's independent t-tests for unequal variances.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Oral Health education including printed educational materialParticipants will receive previously designed educational material with recommendations for healthy habits and oral health recommendations. Also, pediatricians will give the parents oral health education. Parents and their children will receive toothbrushes as well as toothpaste. |
| Control Group | No intervention | –Parents and their children will receive toothbrushes as well as toothpaste. |
Who may qualify
- Ages
- 10 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children
- Parents agreed to participate in the program
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Oral Health education including printed educational materialPrinted and online educational materials were developed and provided to pediatricians so they can share relevant information about caries control to parents of toddlers. A previous interview was performed to pediatricians as focus groups to know how they are doing their evaluations and what do they take into account during the children visits in order to identify where to focus for the training what it is necessary to change. After that pediatricians were trained to give oral health recommendations. So, to the intervention group, the pediatricians will give these recommendations to the parents and also they will give them a printed educational material previously developed for the project. | Behavioural | Experimental group |
Primary outcome
Dental caries status
Time frame: Up to ten months
Detection of dental caries lesions using the International Caries Detection and Assessment System (ICDAS) criteria.
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 20 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Kim Ekstrand, PhD study director
The University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health education including printed educational material in people with Dental Caries in Children and Dental Caries, run by Universidad Iberoamericana at 1 site in Dominican Republic.
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 2 inclusion and 1 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 20 Dec 2021. 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 Dominican Republic. 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?
Dental caries status (time frame: Up to ten months). 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 20 Dec 2021.