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

Primary Purpose

Asthma, Dental Caries

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chinese Licorice Root
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Herbal lollipops, Asthma, Dental Caries, Streptococcus mutans levels, DMFT/dmft scores

Eligibility Criteria

4 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Lollipop

Chinese Licorice Root

Arm Description

The placebo group will ingest the same herbal lollipop formula without the active ingredient.

The experimental group will ingest the herbal lollipop formula with the active ingredient.

Outcomes

Primary Outcome Measures

Levels of oral Streptococcus mutans
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
Decayed, missing and filled teeth (DMFT/dmft) score is an index for measuring dental caries.

Full Information

First Posted
June 11, 2010
Last Updated
August 21, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01147835
Brief Title
Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers
Acronym
Lollipops
Official Title
Effects of Herbal Lollipops on Streptococcus Mutans Levels and the Dental Caries Experience of Children With Asthma Taking beta2-adrenergic Agonist Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped and not completed
Study Start Date
September 23, 2009 (Actual)
Primary Completion Date
September 27, 2011 (Actual)
Study Completion Date
September 27, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Dental Caries
Keywords
Herbal lollipops, Asthma, Dental Caries, Streptococcus mutans levels, DMFT/dmft scores

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Lollipop
Arm Type
Placebo Comparator
Arm Description
The placebo group will ingest the same herbal lollipop formula without the active ingredient.
Arm Title
Chinese Licorice Root
Arm Type
Experimental
Arm Description
The experimental group will ingest the herbal lollipop formula with the active ingredient.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chinese Licorice Root
Other Intervention Name(s)
Herbal lollipops, Glycyrrhiza uralensis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Levels of oral Streptococcus mutans
Description
The count of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs).
Time Frame
Measured at baseline and 6 months.
Secondary Outcome Measure Information:
Title
DMFT/dmft score changes
Description
Decayed, missing and filled teeth (DMFT/dmft) score is an index for measuring dental caries.
Time Frame
Measured at baseling and 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Hamilton, DDS
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9643188
Citation
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.
Results Reference
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PubMed Identifier
2887602
Citation
Ryberg 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.
Results Reference
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PubMed Identifier
1871531
Citation
Ryberg 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.
Results Reference
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PubMed Identifier
12739694
Citation
Reddy DK, Hegde AM, Munshi AK. Dental caries status of children with bronchial asthma. J Clin Pediatr Dent. 2003 Spring;27(3):293-5.
Results Reference
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PubMed Identifier
9783301
Citation
McDerra EJ, Pollard MA, Curzon ME. The dental status of asthmatic British school children. Pediatr Dent. 1998 Jul-Aug;20(4):281-7.
Results Reference
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PubMed Identifier
1086008
Citation
Hetzer 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.
Results Reference
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PubMed Identifier
11423718
Citation
Shulman 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.
Results Reference
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PubMed Identifier
17036706
Citation
Milano 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.
Results Reference
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PubMed Identifier
16441081
Citation
He 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.
Results Reference
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Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers

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