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

NCT ID: NCT01147835

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-23
• Study Completion Date: 2011-09-27

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.

Conditions

Asthma; Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Placebo Lollipop

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

Group Type: PLACEBO_COMPARATOR

Chinese Licorice Root

Intervention Type: DIETARY_SUPPLEMENT

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.

Chinese Licorice Root

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

Group Type: EXPERIMENTAL

Chinese Licorice Root

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Herbal lollipops, Glycyrrhiza uralensis

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Hamilton, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 16441081 (View on PubMed)

Other Identifiers

0337-09-FB

Identifier Type: -

Identifier Source: org_study_id