AsthmaLollipopsNCT01147835
Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers
A study testing Chinese Licorice Root in people with Asthma and Dental Caries, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Dental Caries
- What is being tested?
- Chinese Licorice Root
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2009to 27 Sep 2011
- 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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children who do not fall within all the aforementioned inclusion criteria will not be considered for participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Effects of Herbal Lollipops on Streptococcus Mutans Levels and the Dental Caries Experience of Children With Asthma Taking beta2-adrenergic Agonist Drugs
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.
Read the detailed description
This study is entitled, "Effects of herbal lollipops on Streptococcus Mutans levels and the dental caries experience of children with asthma taking beta2-adrenergic drugs." In this study, forty-five (45) children between the ages of four (4) and sixteen (16) with bronchial asthma taking a beta2-adrenergic agonist drug at least once a week will participate in a six (6) month regimen of herbal lollipops as adjunctive oral hygiene therapy. The objective of this study is to determine how effective the six-month regimen of herbal lollipops is at controlling the Streptococcus Mutans levels and the caries process in the study group. Whether or not a case can be made for including herbal lollipops in standard oral hygiene protocol for children with asthma will also be a goal of this study. Relevant data will be collected using the following method. The subjects of this study will be provided with and instructed to dissolve two (2) herbal lollipops by mouth per day for the first ten (10) days of the study and again for ten (10) days three (3) months into the study. Each subject will receive a total of forty (40) lollipops for the study. The study group will be matched with a control group of forty-five (45) children who also have asthma and who take beta2-adrenergic agonist drugs as needed for symptoms. The children in the control group will be given placebo lollipops and will be instructed to use them in the manner described above. All ninety (90) subjects will be drawn from the collective patient pools of the UNMC College of Dentistry in Lincoln, NE, and the UNMC Pediatric Dentistry and UNMC Pediatrics Clinics in Omaha, NE. Oral hygiene instructions will be given to all participating subjects at the onset of the study. Entrance Streptococcus mutans levels and decayed, missing and filled teeth scores (DMFT/dmft) will be determined on the subjects and changes over the six (6) month study will be compared and evaluated. If some stabilization or improvement in the Streptococcus mutans levels and/or dental caries experience in the study group is shown, such promising results will allow for implementation of longer-term studies. The significance of this study is that adjunctive oral hygiene therapy that employs herbal lollipops may prove to help children who suffer from bronchial asthma lower their dental caries risks and have healthier oral environments unburdened by the effects of their medication and condition.
- Conditions
- Asthma, Dental Caries
- Being tested
- Chinese Licorice Root
- Keywords
- Herbal lollipops, Asthma, Dental Caries, Streptococcus mutans levels, DMFT/dmft scores
- Medical subject headings
- Asthma, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Licorice RootDietary supplement
Also called Herbal lollipops, Glycyrrhiza uralensis
Chinese Licorice Root lollipops are given to the subjects in the study group to ingest twice daily for 10 days. Then the subjects must wait 3 months, and then again ingest the lollipops twice daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Lollipop | Placebo comparator | The placebo group will ingest the same herbal lollipop formula without the active ingredient. Receives: Dietary Supplement: Chinese Licorice Root |
| Chinese Licorice Root | Experimental | The experimental group will ingest the herbal lollipop formula with the active ingredient. Receives: Dietary Supplement: Chinese Licorice Root |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of oral Streptococcus mutans
The count of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs).
Measured: Measured at baseline and 6 months.
Secondary outcomes (1)
DMFT/dmft score changes
Decayed, missing and filled teeth (DMFT/dmft) score is an index for measuring dental caries.
Measured: Measured at baseling 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 posted22 Jun 2010 (estimated)
- Study start23 Sep 2009
- Primary completion27 Sep 2011
- Study completion27 Sep 2011
Why it stopped: Study was stopped and not completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Hamilton, DDS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147835
- Sponsor's protocol ID
- 0337-09-FB
- Acronym
- Lollipops
- Status last verified
- Aug 2023
- First submitted
- 11 Jun 2010
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kargul B, Tanboga I, Ergeneli S, Karakoc F, Dagli E. Inhaler medicament effects on saliva and plaque pH in asthmatic children. J Clin Pediatr Dent. 1998 Winter;22(2):137-40.
PubMed 9643188Ryberg M, Moller C, Ericson T. Effect of beta 2-adrenoceptor agonists on saliva proteins and dental caries in asthmatic children. J Dent Res. 1987 Aug;66(8):1404-6. doi: 10.1177/00220345870660082401.
PubMed 2887602Ryberg M, Moller C, Ericson T. Saliva composition and caries development in asthmatic patients treated with beta 2-adrenoceptor agonists: a 4-year follow-up study. Scand J Dent Res. 1991 Jun;99(3):212-8. doi: 10.1111/j.1600-0722.1991.tb01887.x.
PubMed 1871531Reddy DK, Hegde AM, Munshi AK. Dental caries status of children with bronchial asthma. J Clin Pediatr Dent. 2003 Spring;27(3):293-5.
PubMed 12739694McDerra EJ, Pollard MA, Curzon ME. The dental status of asthmatic British school children. Pediatr Dent. 1998 Jul-Aug;20(4):281-7.
PubMed 9783301Hetzer R, Heim K, Borst HG, Amende I, Sigwart U. [Cineradiographical studies of local ventricular motility before and after aorto-coronary bypass (author's transl)]. Thoraxchir Vask Chir. 1976 Aug;24(4):296-302. doi: 10.1055/s-0028-1095932. German.
PubMed 1086008Shulman JD, Taylor SE, Nunn ME. The association between asthma and dental caries in children and adolescents: A population-based case-control study. Caries Res. 2001 Jul-Aug;35(4):240-6. doi: 10.1159/000047464.
PubMed 11423718Milano M, Lee JY, Donovan K, Chen JW. A cross-sectional study of medication-related factors and caries experience in asthmatic children. Pediatr Dent. 2006 Sep-Oct;28(5):415-9.
PubMed 17036706He J, Chen L, Heber D, Shi W, Lu QY. Antibacterial compounds from Glycyrrhiza uralensis. J Nat Prod. 2006 Jan;69(1):121-4. doi: 10.1021/np058069d.
PubMed 16441081
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Herbal Lollipops on Streptococcus Mutans Levels and the Dental Caries Experience of Children With Asthma Taking beta2-adrenergic Agonist Drugs
- ClinicalTrials.gov ID
- NCT01147835
- Acronym / sponsor ID
- Lollipops / 0337-09-FB
- Conditions
- Asthma, Dental Caries
- Keywords
- Herbal lollipops, Asthma, Dental Caries, Streptococcus mutans levels, DMFT/dmft scores
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped and not completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 23 Sep 2009 (actual)
- Primary completion
- 27 Sep 2011 (actual)
- Study completion
- 27 Sep 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- 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.
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.
Detailed description
This study is entitled, "Effects of herbal lollipops on Streptococcus Mutans levels and the dental caries experience of children with asthma taking beta2-adrenergic drugs." In this study, forty-five (45) children between the ages of four (4) and sixteen (16) with bronchial asthma taking a beta2-adrenergic agonist drug at least once a week will participate in a six (6) month regimen of herbal lollipops as adjunctive oral hygiene therapy. The objective of this study is to determine how effective the six-month regimen of herbal lollipops is at controlling the Streptococcus Mutans levels and the caries process in the study group. Whether or not a case can be made for including herbal lollipops in standard oral hygiene protocol for children with asthma will also be a goal of this study. Relevant data will be collected using the following method. The subjects of this study will be provided with and instructed to dissolve two (2) herbal lollipops by mouth per day for the first ten (10) days of the study and again for ten (10) days three (3) months into the study. Each subject will receive a total of forty (40) lollipops for the study. The study group will be matched with a control group of forty-five (45) children who also have asthma and who take beta2-adrenergic agonist drugs as needed for symptoms. The children in the control group will be given placebo lollipops and will be instructed to use them in the manner described above. All ninety (90) subjects will be drawn from the collective patient pools of the UNMC College of Dentistry in Lincoln, NE, and the UNMC Pediatric Dentistry and UNMC Pediatrics Clinics in Omaha, NE. Oral hygiene instructions will be given to all participating subjects at the onset of the study. Entrance Streptococcus mutans levels and decayed, missing and filled teeth scores (DMFT/dmft) will be determined on the subjects and changes over the six (6) month study will be compared and evaluated. If some stabilization or improvement in the Streptococcus mutans levels and/or dental caries experience in the study group is shown, such promising results will allow for implementation of longer-term studies. The significance of this study is that adjunctive oral hygiene therapy that employs herbal lollipops may prove to help children who suffer from bronchial asthma lower their dental caries risks and have healthier oral environments unburdened by the effects of their medication and condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Lollipop | Placebo comparator | Dietary Supplement: Chinese Licorice RootThe placebo group will ingest the same herbal lollipop formula without the active ingredient. |
| Chinese Licorice Root | Experimental | Dietary Supplement: Chinese Licorice RootThe experimental group will ingest the herbal lollipop formula with the active ingredient. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Children who do not fall within all the aforementioned inclusion criteria will not be considered for participation in this 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 |
|---|---|---|
| Chinese Licorice RootAlso: Herbal lollipops, Glycyrrhiza uralensisChinese Licorice Root lollipops are given to the subjects in the study group to ingest twice daily for 10 days. Then the subjects must wait 3 months, and then again ingest the lollipops twice daily for 10 days. | Dietary supplement | Chinese Licorice Root, Placebo Lollipop |
Primary outcome
Levels of oral Streptococcus mutans
Time frame: Measured at baseline and 6 months.
The count of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs).
1 secondary outcome
DMFT/dmft score changes
Time frame: Measured at baseling and 6 months.
Results and safety
The study was stopped early (reason given: Study was stopped and not completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Background: PubMed 9643188Kargul B, Tanboga I, Ergeneli S, Karakoc F, Dagli E. Inhaler medicament effects on saliva and plaque pH in asthmatic children. J Clin Pediatr Dent. 1998 Winter;22(2):137-40.
- Background: PubMed 2887602Ryberg M, Moller C, Ericson T. Effect of beta 2-adrenoceptor agonists on saliva proteins and dental caries in asthmatic children. J Dent Res. 1987 Aug;66(8):1404-6. doi: 10.1177/00220345870660082401.
- Background: PubMed 1871531Ryberg M, Moller C, Ericson T. Saliva composition and caries development in asthmatic patients treated with beta 2-adrenoceptor agonists: a 4-year follow-up study. Scand J Dent Res. 1991 Jun;99(3):212-8. doi: 10.1111/j.1600-0722.1991.tb01887.x.
- Background: PubMed 12739694Reddy DK, Hegde AM, Munshi AK. Dental caries status of children with bronchial asthma. J Clin Pediatr Dent. 2003 Spring;27(3):293-5.
- Background: PubMed 9783301McDerra EJ, Pollard MA, Curzon ME. The dental status of asthmatic British school children. Pediatr Dent. 1998 Jul-Aug;20(4):281-7.
- Background: PubMed 1086008Hetzer R, Heim K, Borst HG, Amende I, Sigwart U. [Cineradiographical studies of local ventricular motility before and after aorto-coronary bypass (author's transl)]. Thoraxchir Vask Chir. 1976 Aug;24(4):296-302. doi: 10.1055/s-0028-1095932. German.
- Background: PubMed 11423718Shulman JD, Taylor SE, Nunn ME. The association between asthma and dental caries in children and adolescents: A population-based case-control study. Caries Res. 2001 Jul-Aug;35(4):240-6. doi: 10.1159/000047464.
- Background: PubMed 17036706Milano M, Lee JY, Donovan K, Chen JW. A cross-sectional study of medication-related factors and caries experience in asthmatic children. Pediatr Dent. 2006 Sep-Oct;28(5):415-9.
- Background: PubMed 16441081He J, Chen L, Heber D, Shi W, Lu QY. Antibacterial compounds from Glycyrrhiza uralensis. J Nat Prod. 2006 Jan;69(1):121-4. doi: 10.1021/np058069d.
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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.
Scott Hamilton, DDS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Licorice Root in people with Asthma and Dental Caries, run by University of Nebraska 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 5 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: stopped early, as of the sponsor's last update on 23 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 was stopped early (reason given: Study was stopped and not completed). 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?
Levels of oral Streptococcus mutans (time frame: Measured at baseline and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147835, which also lists 9 linked publications.
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 23 Aug 2023.