Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
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Asthma Dental Caries |
Dietary Supplement: Chinese Licorice Root |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Effects of Herbal Lollipops on Streptococcus Mutans Levels and the Dental Caries Experience of Children With Asthma Taking beta2-adrenergic Agonist Drugs |
- Levels of oral Streptococcus mutans [ Time Frame: Measured at baseline and 6 months. ] [ Designated as safety issue: No ]The count of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs).
- DMFT/dmft score changes [ Time Frame: Measured at baseling and 6 months. ] [ Designated as safety issue: No ]Decayed, missing and filled teeth (DMFT/dmft) score is an index for measuring dental caries.
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Lollipop
The placebo group will ingest the same herbal lollipop formula without the active ingredient.
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Dietary Supplement: Chinese Licorice Root
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.
Other Name: Herbal lollipops, Glycyrrhiza uralensis
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Experimental: Chinese Licorice Root
The experimental group will ingest the herbal lollipop formula with the active ingredient.
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Dietary Supplement: Chinese Licorice Root
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.
Other Name: Herbal lollipops, Glycyrrhiza uralensis
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Angela Cook, BA | 720-284-8999 | angela.k.cook@gmail.com |
| Contact: Scott Hamilton, DDS | (402) 472-1306 | shamilton@unmc.edu |
| United States, Nebraska | |
| University of Nebraska Medical Center, Pediatric Dentistry Residency | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Elizabeth Johnson, DDS 402-770-7697 | |
| Principal Investigator: Elizabeth Johnson, DDS | |
| Sub-Investigator: Scott Hamilton, DDS | |
More Information
Publications:
| Responsible Party: | Angela Cook, University of Nebraska Medical Center College of Dentistry |
| ClinicalTrials.gov Identifier: | NCT01147835 History of Changes |
| Other Study ID Numbers: | 337-09 |
| Study First Received: | June 11, 2010 |
| Last Updated: | June 23, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Nebraska:
|
Herbal lollipops Asthma Dental Caries Streptococcus mutans levels DMFT/dmft scores |
Additional relevant MeSH terms:
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Asthma Dental Caries Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Tooth Demineralization Tooth Diseases Stomatognathic Diseases Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013