LeukemiaNCT03281746
Effect of Prevention Education in Caries Formation in Pediatric Patients With Leukemia
A study testing Dental Procedure, Educational Intervention (prevention education) and Interview in people with Leukemia, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies how well preventive education works in decreasing caries formation in pediatric patients with leukemia. Prevention education may have an effect on factors important in causing cavities in pediatric patients with leukemia. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Dental Procedure, Educational Intervention (prevention education) and Interview
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2017to 2 Mar 2018
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients who have been recently diagnosed with leukemia
- Patients will also predictably be in primary or mixed dentition
- Patients of Virginia Commonwealth University Medical Center Pediatric Hematology Oncology Clinic
Who cannot join
- Full permanent dentition
- Primary language is not English
- Children in the custody of the state with no parent or legal guardian present to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Effect of Prevention Education on Factors of Importance in Caries Formation in Pediatric Patients With Leukemia
This randomized pilot clinical trial studies how well preventive education works in decreasing caries formation in pediatric patients with leukemia. Prevention education may have an effect on factors important in causing cavities in pediatric patients with leukemia.
Read the detailed description
Patients treated for leukemia at Virginia Commonwealth University Medical Center in the department of Pediatric Hematology and Oncology are currently receiving oral hygiene instruction at diagnosis. In this study, patients will be randomized into two groups at diagnosis: one receiving current prevention education and the other group receiving one-on-one prevention education and counseling with the physician and pediatric dental resident. Physician and pediatric dental resident will use motivational interviewing informed techniques during counseling. A caries risk assessment will be performed for each patient at diagnosis. Caries incidence, plaque scores, mutans streptococci levels, salivary flow rate, and salivary pH will be assessed at week one (diagnosis), week 16 or start of interim maintenance therapy whichever comes second, week 32 or beginning of maintenance therapy whichever is later for all patients enrolled in the study. Data will be collected through a clinical intraoral examination and salivary sample. Data collected will be used to assess the effect of increased prevention education on factors of importance in caries formation.
- Conditions
- Leukemia
- Being tested
- Dental Procedure, Educational Intervention (prevention education), Interview, Survey Administration, Educational Intervention (one-on one education)
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ProcedureProcedure or surgery
Undergo dental examination
Educational Intervention (prevention education)Other
Also called Education for Intervention, Intervention by Education
Receive prevention education
InterviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
Educational Intervention (one-on one education)Other
Also called Education for Intervention, Educational Intervention, Intervention by Education, Intervention through Education
Receive one-on-one education
| Study group | Role | What they receive |
|---|---|---|
| Group I (standard prevention education) | Active comparator | Patients undergo dental examination at baseline and then receive standard prevention education at diagnosis discussing the effects of prolonged neutropenia on oral hygiene, importance of a regular oral hygiene regimen, and the long term clinical outcomes of oncologic patients. Patients also receive fliers with pictograms describing proper brushing, use of mouth wash, and common oral complications during therapy, as well as a bottle and prescription for chlorhexidine gluconate 0.12% rinse. Receives: Procedure: Dental Procedure; Other: Educational Intervention (prevention education); Other: Interview; Other: Survey Administration |
| Group II (standard and one-on-one education, consultation) | Experimental | Patients undergo dental examination and receive standard prevention education as in Group I. Patients also receive one-on-one prevention education and counseling with the physician and pediatric dental resident. Receives: Procedure: Dental Procedure; Other: Educational Intervention (prevention education); Other: Interview; Other: Survey Administration; Other: Educational Intervention (one-on one education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caries assessed by CAMBRA risk assessment tool
Measured: Baseline up to 32 weeks
Change in salivary flow rate
Change in salivary flow rate will be measured utilizing pre-weighed cotton rolls. Patients will saturate as many cotton rolls as possible in one minute by chewing. Dose cups and cotton rolls will be weighed prior to and after data collection. The change in weight in grams will be converted to mL of saliva collected.
Measured: Baseline up to 32 weeks
Change in salivary pH
Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.
Measured: Baseline up to 32 weeks
Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth
Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.
Measured: Baseline up to 32 weeks
Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)
Measured: Baseline up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start19 May 2017
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Helou A Marieka, MD, MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281746
- Sponsor's protocol ID
- MCC-16-13019
- Other IDs
- NCI-2017-01354
- Status last verified
- Feb 2020
- First submitted
- 7 Sep 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prevention Education on Factors of Importance in Caries Formation in Pediatric Patients With Leukemia
- ClinicalTrials.gov ID
- NCT03281746
- Acronym / sponsor ID
- MCC-16-13019
- Conditions
- Leukemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 13 Sep 2017 (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.
This randomized pilot clinical trial studies how well preventive education works in decreasing caries formation in pediatric patients with leukemia. Prevention education may have an effect on factors important in causing cavities in pediatric patients with leukemia.
Detailed description
Patients treated for leukemia at Virginia Commonwealth University Medical Center in the department of Pediatric Hematology and Oncology are currently receiving oral hygiene instruction at diagnosis. In this study, patients will be randomized into two groups at diagnosis: one receiving current prevention education and the other group receiving one-on-one prevention education and counseling with the physician and pediatric dental resident. Physician and pediatric dental resident will use motivational interviewing informed techniques during counseling. A caries risk assessment will be performed for each patient at diagnosis. Caries incidence, plaque scores, mutans streptococci levels, salivary flow rate, and salivary pH will be assessed at week one (diagnosis), week 16 or start of interim maintenance therapy whichever comes second, week 32 or beginning of maintenance therapy whichever is later for all patients enrolled in the study. Data will be collected through a clinical intraoral examination and salivary sample. Data collected will be used to assess the effect of increased prevention education on factors of importance in caries formation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (standard prevention education) | Active comparator | Procedure: Dental Procedure, Other: Educational Intervention (prevention education), Other: Interview, Other: Survey AdministrationPatients undergo dental examination at baseline and then receive standard prevention education at diagnosis discussing the effects of prolonged neutropenia on oral hygiene, importance of a regular oral hygiene regimen, and the long term clinical outcomes of oncologic patients. Patients also receive fliers with pictograms describing proper brushing, use of mouth wash, and common oral complications during therapy, as well as a bottle and prescription for chlorhexidine gluconate 0.12% rinse. |
| Group II (standard and one-on-one education, consultation) | Experimental | Procedure: Dental Procedure, Other: Educational Intervention (prevention education), Other: Interview, Other: Survey Administration, Other: Educational Intervention (one-on one education)Patients undergo dental examination and receive standard prevention education as in Group I. Patients also receive one-on-one prevention education and counseling with the physician and pediatric dental resident. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients who have been recently diagnosed with leukemia
- Patients will also predictably be in primary or mixed dentition
- Patients of Virginia Commonwealth University Medical Center Pediatric Hematology Oncology Clinic
Key exclusion criteria (3 listed)
- Full permanent dentition
- Primary language is not English
- Children in the custody of the state with no parent or legal guardian present to sign consent
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 |
|---|---|---|
| Dental ProcedureUndergo dental examination | Procedure or surgery | Group I (standard prevention education), Group II (standard and one-on-one education, consultation) |
| Educational Intervention (prevention education)Also: Education for Intervention, Intervention by EducationReceive prevention education | Other | Group I (standard prevention education), Group II (standard and one-on-one education, consultation) |
| InterviewAncillary studies | Other | Group I (standard prevention education), Group II (standard and one-on-one education, consultation) |
| Survey AdministrationAncillary studies | Other | Group I (standard prevention education), Group II (standard and one-on-one education, consultation) |
| Educational Intervention (one-on one education)Also: Education for Intervention, Educational Intervention, Intervention by Education, Intervention through EducationReceive one-on-one education | Other | Group II (standard and one-on-one education, consultation) |
Primary outcome
Change in caries assessed by CAMBRA risk assessment tool
Time frame: Baseline up to 32 weeks
Change in salivary flow rate
Time frame: Baseline up to 32 weeks
Change in salivary flow rate will be measured utilizing pre-weighed cotton rolls. Patients will saturate as many cotton rolls as possible in one minute by chewing. Dose cups and cotton rolls will be weighed prior to and after data collection. The change in weight in grams will be converted to mL of saliva collected.
Change in salivary pH
Time frame: Baseline up to 32 weeks
Will be measured with litmus paper in the gingival sulcus of the tooth where plaque is collected for bacterial load testing.
Change in levels of mutans streptococci in buccal surface of most posterior maxillary right tooth
Time frame: Baseline up to 32 weeks
Samples will be plated on mitis salivarius and incubated. Mutans streptococci colonies will be counted after incubation.
Change in caries assessed by Merged International Caries Detection and Assessment System (ICDAS)
Time frame: Baseline up to 32 weeks
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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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.
Helou A Marieka, MD, MPH 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 Dental Procedure, Educational Intervention (prevention education) and Interview in people with Leukemia, 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: stopped early, as of the sponsor's last update on 25 Feb 2020. 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?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
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 caries assessed by CAMBRA risk assessment tool (time frame: Baseline up to 32 weeks). The study lists 5 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 25 Feb 2020.