SubjectsareenrolledinthestudywithIRBapproval

SubjectsarepatientsofrecordatUNMC,have
medicaldiagnosesofasthmaandaretreatedweekly
with2adrenergicagonistinhalers
Assignmentofsubjectstotheherballollipopor
controlgroupisdeterminedbyarandomizedlist

Determinewhetherornotherballollipopsshouldbe
usedasdirectivetherapyforchildrenwithasthma.

Thedurationofthestudyissixmonthsfrom
enrollmenttocompletionandisconductedasfollows:

Dr.JohnsoncompletesaclinicalDMFT/
dmftscreeningonanasthmapatient.

Bitewingsaretakenfortheradiographic
determinationofDMFT/dmftscores.

Asampleofthepatientssalivaispipetted
ontotheCRTbacteriateststrip.

Thesalivasamplesareculturedat37oC
for48hours.

S.mutanscoloniesarecountedand
recordedafterculture.

Patientsmileswithhisrstround
oforangelollipops.

STUDY
FLOWCHART
Patient
Enrolled

Herbal
Group
S.mutans
Test

DispenseHerbal
Lollipops

Subjectdemographicinformationiscollectedduring
studyenrollment.
GeneralSubjectInformation(n=13):

Placebo
Group
S.mutans
Test

DMFT/dmft
score

DispensePlacebo
Lollipops

GeneralCharacteristics
Male=9,Female=4
AA=7,Caucasian=2,Hispanic=4
9.52.8years

Gender
Ethnicity
AverageAge

AverageYearlyFamilyIncome

ASTHMACLASSIFICATION
17%

RellHerbal
Lollipops

RellPlacebo
Lollipops

Recall

Recall

DMFT/dmft
score

S.mutans
Test

DMFT/dmft
score

S.mutans
Test

Disclose
Outcome

TheDMFT/dmftscoresandS.mutanstestsforeach
grouparecomparedwithregardtothechange
measuredineachoverthesixmonthcourse.

AFFECTSONQUALITYOFLIFE
17% 8%

33%

50%

Moderate

Severe

ASTHMARELATEDSCHOOL
ABSENCESINTHELASTYEAR
8%

PreliminaryresultsareanticipatedinmidApril2010as
theearliestenrolledsubjectscompletethestudyinits
entirety.Enrollmentofeligiblesubjectsisongoingand
willcontinueuntil90subjectssuccessfullycomplete
thestudy.Theecacyofherballollipoptherapyfor
asthmaticchildrenwillthenbedeterminedstatistically.

17%

58%

Alot

Moderate

Alittle

17%

83%

1to7

8to30

Notatall

PARENTKNOWLEDGEOF
DENTALSIDEEFFECTS

42%

50%

Disclose
Outcome

22.8K12.4K

SubjectAsthmaInformation(n=13):

Mild

SubjectsMUST:
*Haveamedicaldiagnosisofasthmaandusea2
adrenergicagonistinhalerasneededforsymptoms
*Bebetweentheagesof4and16years
*Beavailableforrecall
SubjectsMUSTNOT:
*Betakingotherxerostomiacausingmedications
unrelatedtothetreatmentofasthma
*Havehistoryofsevereearlychildhoodcaries(SECC)

CRTbacteria
Streptococcusmutans
testsweremanufactured
byIvoclarVivodent,
Amherst,NY

Thestudyisdoubleblind;boththeresearcherandthe
subjectsareunawareofgroupassignments

DMFT/dmft
score

Determinehoweectiveasixmonthcourseofherbal
lollipopsisonS.mutanslevelsandthedentalcaries
experienceofasthmaticchildrenversusaplacebo

Herballollipopswere
manufacturedby
IntelliherbLLC,
Inglewood,CAandare
FDAapproved

Yes

No

Allphotosweretakenandprintedwithparentalpermission.

Dentalcariesandasthmaaretwoofthemost
commonchronicdiseasesofchildhood
Presently,9.3%ofchildrenintheUnitedStatessuer
fromsomeformofasthma
Childrenwhoaretreatedwith2adrenergic
agonistinhalersforasthmahavebeenshowntohave:
*Decreasedsalivaryoutowwhichlimits
theprotectivebuerofsaliva
*DecreasedplaquepHbelowthecriticalpH
forenameldemineralization
*HigherDMFT/dfmtscores
Studiesstronglyrecommendadditionalpreventative
programsforchildrenwithasthmatokeepdental
cariesrisksundercontrol
HerballollipopscontainGlycyrrihizauralensis,a
compoundextractedfromChineselicoriceroot,which
hasdemonstratedantibacterialactivityagainst
Streptococcusmutans(S.mutans),anoralpathogen
responsiblefordentalcaries
Itishypothesizedthatasixmonthcourseofherbal
lollipopswillreduceS.mutanspopulationsinsaliva
ofchildrenwithasthma,andthereby,improveDMFT/
dmftscores

SpecialthankstoJeeryPayneDDS,PeterGiannini
DDS,MS,MichaelMolvarDDS,MSandCarenBarnes
RDH,MSofUNMCCollegeofDentistry.Also,thanks
toMaxwellH.AndersonDDS,MS,MEdandJustin
HsiaoofC3Jian,Inc.