Treatment of Periodontitis Utilizing Two Different Modalities: Erbium-doped Yttrium Aluminium Garnet (Er:YAG) Laser and Conventional Mechanical Debridement
Phase: NA
Conditions: Generalized Moderate Chronic Periodontitis, Generalized Severe Chronic Periodontitis, Periodontal Diseases
Sponsor: Columbia University

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Title:  Er: Y A G vers us Scali n g a n d R o ot Pla ni n g f or t he Treat me nt of Peri o d o ntal 
Disease: A Si n gle -Bli n de d S plit -M o ut h Ra n d o mize d Cli nical Trial  
Pr ot oc ol Versi o n #: Laser 2 0 1 7 v 1 
I R B A p pr o ve d Effecti ve Date: 0 1/ 2 6/ 2 0 1 8 

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Pr ot oc ol: A A A R 6 0 7 7  
Pr ot oc ol Stat us: A p pr o ve d Effecti ve Date: 0 1/ 2 6/ 2 0 1 8  
E x pirati o n Date: 0 1/ 0 9/ 2 0 1 9  
Pri nci pal I n v esti gat or: K a n g, P hili p Y  
C o -i n vesti gat or a n d lea d a ut h or: G ur pe g ui A b u d, Da niela  
C o -i n vesti gat or: S hariff, Jaffer A  
C o -i n vesti gat or: Li n de n, Eric  
Title: Er: Y A G vers us Scali n g a n d R o ot Pla ni n g f or t he Treat me nt of Peri o d o ntal Disease: A 
Si n gle -Bli n de d S plit -M o ut h Ra n d o mize d Cli n ical Trial 
Pr ot oc ol Versi o n #: Laser 2 0 1 7 v 1  
A b bre viate d Title: Tr eat me nt of Peri o d o ntitis wit h Er: Y A G laser  
 
B A C K G R O U N D  
 
S T U D Y P U R P O S E A N D R A TI O N A L E  
T he p ur p ose of t his st u d y was  t o e xa mi ne t he c ha n ges i n cli nical para meters 3 m o nt hs after n o n -
s ur gical peri o d o ntal tr eat me nt 
w as perf or me d 
wit h t w o differe nt treat me nt 
m o d alities , 
c o n ve nti o nal scali n g a n d r o ot pla ni n g a n d Er: Y A G laser.  
 
S T U D Y D E SI G N  
T he st u d y was c o n d u cte d as a ra n d o mize d, s plit-m o ut h cli nical trial . T hirt y  s u bjects were  recr uite d 
a n d ri g ht a n d l eft si de ( u p per a n d l o wer q ua dra nt o n eac h si de) of t he patie nts' m o ut hs were  
ra n d o ml y assi g ne d t o t he t w o treat me nt m o dalities: 
 
1.  C o n ve nti o nal scali n g a n d r o ot pla ni n g :  
Treat me nt was p erf or me d wit h C a vitr o n®  a n d h a n d i nstr u me ntati o n ( 1 1/ 1 2 a n d 1 3/ 1 4 
grace y ’s, 1 1/ 1 2 a n d 1 3/ 1 4 mi ni grace y’s, 4 R/ 4 L c urette a n d sic kle  s caler) 
 
2.  Er: Y A G laser: 
Treat me nt w as p erf or m e d wit h Ca vitr o n ® a n d t h e laser s et at 5 0 mJ a n d 2 0 p ps, wit h water 
irri gati o n (set at 1 0) a n d air c o oli n g  (set at 7). C 4 0 0 F a n d P S 6 0 0 T ti ps (J. M O RI T A  M F G. 
C O R P, K y ot o, Ja pa n)  were use d. Er: Y A G was use d f or f urt her calc ul us re m o val; r o ot 
de bri de me nt a n d dec o nta mi nati o n; a blati o n of t he e pit helial li ni n g t o a v oi d d o w n gr o wt h of 
e pit heli u m; a n d a blati o n of dis ease d c o n n ecti ve tiss ue, i n t he i n ner s urface of t he gi n gi val 
e pit heli u m a n d/ or i n a n y e xisti n g vertical defect. Re m o val of i nfla me d e pit helial a n d 
c o n necti ve tiss ues o n t h e e xter nal s urface was als o ac hie ve d i n or der t o pr o m ote faster 
i nfla m mati o n re d uctio n. S u bse q ue ntl y, bl o o d c oa g ulati o n 
was acc o m plis he d 
wit h 
def oc use d irra diati o n a n d wit h o ut t he c o oli n g water s pra y. Irra di ati o n was acc o m plis he d 
usi n g t he ti p parallel t o t he r o ot s urfaces, starti n g at t he dee pest p orti o n of t he peri o d o ntal 
p oc ket, i n a s wee pi n g m oti o n, sl o wl y m o vi n g t o war ds t he c or o nal as pect of t he p oc ket.  
 
 

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I ncl usi o n criteri a: 
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Si g ne d a n d date d I nf or me d C o nse nt
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G o o d ge neral healt h
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Partici pa nts ≥ 1 8 years of a ge
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Partici pa nts wit h ≥ 2 0 teet h wit h 5 teet h, i ncl u di n g at least 1 m olar, i n eac h q ua dra nt of t he
m o ut h
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Partici pa nts wit h ≥ 3 0 % of t he prese nt teet h wit h Pr o bi n g de pt hs of > 4 m m a n d B o P
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N o n -s m o ker a n d f or mer s m o kers (st o p pe d s m o ki n g > 1 year)
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Partici pa nts t hat ha ve n ot recei v e d a n y peri o d o ntal treat me nt i n t he past 3 m o nt hs
Excl usi o n crit eri a: 
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Partici pa nts wit h u nc o ntr olle d s yste mic diseases t hat c o ul d affect t he tr eat me nt o utc o me s uc h
as Dia betes wit h H b A 1 c > 7. 0 perce nt, r he u m at oi d art hritis , i m m u n os u p pressi o n, HI V wit h
de tecta ble vir al l oa ds
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Partici pa nts re q uiri n g a nti bi otic pr o p h yla xis f or a n y car di o vas c ular c o n diti o ns or after a n y
tra ns pla nt a n d/ or re place me nt pr oce d ures
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Pre g na n c y
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Patie nts treate d wit h s yste mic a nti bi otic t hera p y of peri o d o ntal/ mec h a nical/l ocal deli ver y
t hera p y wit hi n 6 wee ks pri or t o st u d y e ntr y a n d t hr o u g h o ut t he st u d y d urati o n
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Patie nts bei n g c hr o nicall y (t w o wee ks or m ore) treate d wit h a n y N S AI Ds, ster oi ds or a n y
me dicati o ns k n o w n t o affect s oft tiss ue c o n diti o n (e xcl u di n g treat me nt wit h Acet ylsalic ylic
aci d < 1 0 0 m g/ da y)
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Prese nce of ort h o d o ntic a p plia nces, or a n y re m o va ble a p plia nces t hat i m pi n ges o n t he tiss ues
bei n g assesse d
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Prese nce of s oft or har d tiss ue t u m ors of t he oral ca vit y
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T he prese n ce of a n y me dical or ps yc hiatric c o n diti o n or a n y ot her c o n diti o n t hat, i n t he
o pi ni o n of t he I n v esti gat or, c o ul d affect t he s u ccessf ul partici pati o n of t he patie nt i n t he st u d y
R E C R UI T M E N T  
All patie nts see n i n t he pre-d oct or al a n d p ost -d o ct oral cli nics at C ol u m bia U ni versit y C olle ge of 
De ntal Me di ci ne w ere  c o nsi dere d as p ote ntial s u bj ects , a n d all st u de nts, resi de nts a n d fac ult y were 
i nf or me d of t his st u d y. If a n y p atie nt met t h e i ncl usi o n/excl usi o n criteria a n d s h o w e d i nterest, t he 
st u d y pr o vi der was c o nt act e d t o pr o vi de t he patie nt wit h m ore i nf or mati o n.  
S T U D Y P R O C E D U R E S  
Micr os oft ® E xcel s oft w are w as use d t o ge n erat e t he ra n d o m se q u e nce t hat all ocate d ri g ht a n d l eft 
si des (i ncl u di n g u p per a n d l o wer q ua dra nt o n eac h si de) t o t he treat me nt 
m o dalities. 
Ra n d o mizati o n was ke pt i n a n e ncr y pte d c o m p uter t o w hic h o nl y t he pr o vi der ha d access t o. 
All ocati o n was re v eale d o nl y t o pr o vi der i m me diatel y pri or t o t he first treat me nt a p p oi nt me nt.  

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E xa mi ne r was  bli n de d wit h res pect t o w hic h o ne of t he t w o t hera pies was re n dere d  d uri n g t he 
e ntire d urati o n of t he st u d y.   
VI S IT S:  
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1 S T  VI SI T: Re vie w el ectr o nic healt h rec or ds, i ncl u di n g me dical hist or y, me dicati o ns a n d de ntal
x ra ys, c hec k i ncl usi o n a n d e xcl usi o n criteria, s ol ve a n y q uesti o ns t he patie nt ma y  h a ve a n d
o btai n i nf or me d c o nse nt. T he f oll o wi n g c li nical para meters were rec or de d: cli nical attac h me nt
le vel ( C A L), p oc ket de pt hs ( PD), blee di n g o n pr o bi n g ( B o P) a n d pla q ue i n de x ( PI), all of t he m
rec or de d i n 6 sites per t o ot h, a n d t o ot h m o bilit y . Patie nt was  gi ve n oral h y gie ne i nstr ucti o ns .
2 N D  VI SI T * : R e vie w ele ctr o nic healt h rec or ds, i ncl u di n g me dical hist or y, me dicati o ns . Oral
i nspecti o n . Treat me nt of t he assi g ne d si de, b ot h u p per a n d l o w er q ua dra nts, after
ra n d o mizati o n, wit h c o n ve nti o nal scali n g a n d r o ot pla ni n g. Patie nt will be gi ve n oral h y gie ne
i nstr ucti o ns. A nest hesia: I nferi or al ve olar bl o c ks f or t he ma n di ble a n d l ocal i nfiltrati o n f or t he
ma xilla wit h Li d ocai ne 2 % 1: 1 0 0 , 0 0 0 epi ne p hri ne  f or healt h y p atie nts Car b ocai ne 3 % n o
epi ne p hri ne  f or patie nts wit h car di o vasc ul ar iss ues.
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3 R D  VI SI T * : Re vie w ele ctr o nic healt h rec or ds, i ncl u di n g me dical hist or y, me dicati o ns . Oral
i ns pecti o n. Treat me nt of t he assi g ne d si de, b ot h u p per a n d l o w er q ua dra nts, after
ra n d o mizati o n, wit h Er: Y A G laser t h era p y. Patie nt will be gi ve n oral h y gie ne i nstr ucti o ns .
A nest hesia: I nferi or al ve olar bl oc ks f or t he ma n di ble a n d l ocal i nfiltrati o n f or t he ma xilla wit h
Li d ocai ne 2 % 1: 1 0 0 , 0 0 0 epi ne p hri ne  f or h ealt h y patie nts Car b ocai n e 3 % n o epi ne p hri ne  f or
patie nts wit h car di o vasc ular iss ues .
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4 T H  VI SI T , 1 m o nt h f oll o w u p . Re vie w electr o nic healt h rec or ds, i ncl u di n g me dical hist or y,
me dicati o ns . Patie nt was  gi ve n oral h y gie ne i nstr ucti o ns.
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5 T H  VI SI T, 3 m o nt hs f oll o w u p.  Re vie w electr o ni c healt h rec or ds, i ncl u di n g me dical hist or y,
me dicati o ns . T he f oll o wi n g cli nical para meters were rec or de d: C A L, P D, B o P a n d PI, all of
t he m rec or de d i n 6 sites per t o ot h, a n d t o ot h m o bilit y . Peri o d o ntal mai nte na nce wit h Ca vitr o n
® a n d ha n d i nstr u me nts ( 1 1/ 1 2 a n d 1 3/ 1 4 grace y’s, 1 1/ 1 2 a n d 1 3/ 1 4 mi ni grace y’s, 4 R/ 4 L
c urette a n d s i c kle scal er) was perf or me d. Patie nt was gi ve n oral h y gie n e i nstr ucti o ns.
* 2 N D  a n d 3 R D  a p p oi nt me nts were gi ve n wit hi n 1 0 da ys of eac h ot her i n or der t o c o m plete n o n -
s ur gical peri o d o ntal treat me nt of t he w h ole m o ut h wit hi n t hat peri o d of ti me.
I N F O R M E D C O N S E N T P R O C E S S 
I nf or me d c o ns e nt wit h writte n d oc u me ntati o n was o btai ne d fr o m t he researc h partici pa nt , b y st u d y 
pr o vi der.  D ue t o t he hi g h n u m ber of His p a nic patie nts t hat were e x pecte d t o be recr uite d, i nf or me d 
c o nse nt i n E n glis h a n d S pa nis h was create d a n d a p pr o ve d b y C ol u m bia U ni versit y’s Rascal.  

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O B J E C TI V E S  
T he pri mar y  o bje cti ve of t he prese nt st u d y was  t o c o m pare p eri o d o ntal cli nical para meters ( C A L, 
P D, B o P a n d PI) after n o n -s ur gical peri o d o ntal t hera p y c o m plete d wit h t he af ore me nti o ne d 
treat me nt m o dalities .  
Sec o n dar y o bjecti ves  i ncl u de d rec or d t he differe n ces i n d urati o n of treat m e nt bet wee n t he 2 ar ms 
of t he st u d y, as sessi n g t he differe nces i n se nsiti vit y , a n d e val uate s u bjects’ m o dalit y of prefere n ce.
P O T E N TI A L RI S K S A N D B E N E FI T S  
T hera p y f or p eri o d o ntal disease c o ul d i n v ol ve sli g ht s ore ness a n d se nsiti vit y, ma na gea ble wit h a n y 
over -t he-c o u nter a nal gesic. S oft gi n gi val tiss ues c o ul d e x perie n ce s hri n k a g e d ue t o res ol uti o n of 
i nfla m mati o n, sit uati o n i n w hic h cli nical cr o w ns of t he tr eate d teet h c o ul d a p pear t o be sli g htl y 
l o n ger t ha n pre vi o us t o t he t hera p y p erf or me d.  
T here is n o direct be n efit f or partici pati n g i n t he st u d y; partici pa nts will be c o ntri b uti n g t o researc h 
f or treati n g peri o d o ntal disease. H o we ver, after treat me nt, gi ngi val i nfla m mati o n, se nsiti vit y, 
s ore ness, s p o nta n e o us or i n d uce d bl ee di n g a n d h alit osis will i m pr o ve after peri o d o ntal t hera p y. 
O nce t he eti ol o g y of peri o d o ntal disease, bacteria, is re m o ve d, we h o pe t o arrest t he disease 
pr o gressi o n wit h t he pr o vi de d act i ve t hera p y a n d t he s u bse q ue nt recall visits.  
T he alter nati ve is n ot t o partici pate i n t he st u d y. H o we ver peri o d o ntal disease s h o ul d, i n all cases, 
be treate d. T he alter nati v es patie nts w o ul d ha ve , are eit her t o ref use all pr o p ose d treat me nts or t o 
u n der g o  t hera p y wit h  o nl y c o n ve nti o nal ha n d i nstr u me nts.  
S T A TI S TI C A L P R O C E D U R E S
Wilc o x o n si g ne d-ra n k test will be perf or me d t o assess t he si g nifica nce of t he res ults pertai ni n g 
t o C A L a n d P P D (si g nifica nce le vel of 5 %). St u de nt’s t test t o a nal yze B O P sc ores (si g nifica nce 
le vel of 5 %)  S A S 9. 2