TerminatedNot Applicable

Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers

Stopped: Study was stopped and not completed

United States39 participantsStarted 2009-09-23

Plain-language summary

Young children with asthma who use drugs for their asthma are at higher risk for tooth decay. These drugs can cause (1) dry mouth from less saliva secretion and (2) acid mouth that causes teeth to become soft and bacteria to multiply. Herbal lollipops may reduce the risks of tooth decay in young children. The purpose of this research is to determine how well herbal lollipops can improve the negative effects of asthma drugs over a 6-month period. Herbal lollipops contain Chinese licorice root.

Who can participate

Age range

4 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must have a medical diagnosis of asthma and must use a beta2-adrenergic agonist inhaler or nebulizer for their symptoms as needed. * Must not have any other serious medical conditions that require taking another illness-related medication that may cloud the study results. (i.e. medications that have been shown to have anti-sialogogue effects. * Must not have a history of severe early childhood caries (SECC) or "baby bottle tooth decay." * Must fall within the age range of four (4) to sixteen (16) years old. * Must be available to return for data collection during six (6) months of participation in the experiment. Exclusion Criteria: * Children who do not fall within all the aforementioned inclusion criteria will not be considered for participation in this study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Levels of oral Streptococcus mutans

Timeframe: Measured at baseline and 6 months.

Trial details

NCT IDNCT01147835

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-09-27

View on ClinicalTrials.gov More Asthma trials