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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01147835
First received: June 11, 2010
Last updated: June 23, 2010
Last verified: June 2010
  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
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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.
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
Experimental: Chinese Licorice Root
The experimental group will ingest the herbal lollipop formula with the active ingredient.
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147835

Contacts
Contact: Angela Cook, BA 720-284-8999 angela.k.cook@gmail.com
Contact: Scott Hamilton, DDS (402) 472-1306 shamilton@unmc.edu

Locations
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         
Sponsors and Collaborators
University of Nebraska
  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:
Dental Caries
Asthma
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 July 22, 2014