DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient
Phase: NA
Conditions: Time, Patient Preference
Sponsor: Montefiore Medical Center

 
 
 
 
DryShield vs Cotton Roll Isolation  
During Sealants Placement:  
Efficiency and Patient Preference 
 
 
 
 
 
 
 
 
 
NCT#: NCT02995369 
Protocol ID: 2016-7229 
Version Date: 12/7/2016 
 
 
 
 
 
 
PI: Nuntiya Kakanantadilok, DMD 
Program Director 
Pediatric Dentistry, Department of Dentistry 
Montefiore Medical Center 
 
Co-PI: Samantha Nolte, DMD 
Pediatric Dentistry, Department of Dentistry 
Montefiore Medical Center 

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DryShield vs Cotton Roll Isolation during Sealants Placement: Efficiency and Patient Preference. 
Samantha Nolte, DMD
Pediatric Dentistry
Montefiore Medical Center
12/7/16
Elements of Protocol
Introduction and background
In a survey conducted by the National Center for Health Statistics in 2011-
2012, approximately 37% of children aged 2–8 years had experienced dental caries 
in primary teeth. Dental caries among children aged 2–5 was nearly 23% compared 
with 56% among those aged 6–8.  Of children aged 6–11, 21% had experienced 
dental caries in permanent teeth. Dental caries among children aged 6–8 was nearly 
14% and was twice as high for children aged 9–11. Among adolescents aged 12–19, 
58% had experienced dental caries in permanent teeth. The prevalence of dental 
caries experience was higher among adolescents aged 16–19 (67%) compared with 
those aged 12–15 (50%).1 Pit and fissure caries account for 80 to 90 percent of all 
caries in permanent posterior teeth, and 44 percent in primary molars.2 
Pit-and-fissure sealants can be used effectively to prevent caries.  By 
micromechanically bonding to the teeth, they provide a physical barrier that keeps 
microorganisms and food particles from collecting in susceptible pits and fissures, 
thus preventing caries initiation and arresting caries progression.2 
It has been shown that sealants placed on the occlusal surfaces of permanent 
molars in children and adolescents reduced caries up to 48 months when compared 
to no sealants. Moreover, their placement reduces caries incidence of 86 percent 
after one year and 57 percent at 48 to 54 months.3   The effectiveness of sealants for 
caries prevention depends on long-term retention, which is largely a function of 
meticulousness of application: keeping the tooth surface free from saliva 
contamination during application and polymerization is critical4.  Low retention of 
sealants has been attributed to insufficient moisture control. 5 Therefore, proper 
isolation of the teeth is one of the most important steps when placing sealants to 
ensure their retention. 6
Several techniques can be used to isolate teeth when applying sealants. The 
gold standard for isolating teeth has been the rubber dam.  However, it often 
requires the use of a local anesthetic before its placement. Cotton roll isolation (CRI) 
has been widely used as an alternative to rubber dam isolation for sealant 
placement, and is the most common method among pediatric dentists. 7 CRI requires 
placing cotton rolls along the buccal mucosa, especially over the parotid glands 
ducts for maxillary teeth.  For the mandibular teeth, the cotton rolls are placed in the 
buccal vestibule and the floor of the mouth (between the lower buccal mucosa and 
underneath and/or between the tongue). With this technique, a high-speed 
evacuation of saliva and water is used. Although very effective, CRI can be a 
challenging technique especially when used in young children: the cotton rolls can 
be cumbersome for both the patient and the clinician8; additionally, the cotton rolls 
IRB NUMBER: 2016-7229
IRB APPROVAL DATE: 01/17/2017

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have to be changed after and/or during each quadrant as they absorb saliva very 
quickly.6
A previous study demonstrated that new moisture control systems such as 
Isolite, produce sealant retention rates comparable to cotton roll isolation or rubber 
dam, while decreasing procedure time.6,9 DryShield (DS) has recently been 
introduced as an all-in-one isolation system.  It is similar to the Isolite as it combines 
the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block, 
but differs in that it’s autoclavable and does not provide illumination.  Its design 
allows it to suction and isolate half the oral cavity at a time. Therefore, it should 
presumably facilitate sealants placement under a more controlled environment, 
while reducing chair time for the dentist.  Colette et al. evaluated patient satisfaction 
and efficacy of the Isolite during sealant placement, and showed better time 
efficiency with the Isolite system when compared to cotton roll isolation, some 
minor discomfort associated with the Isolite, with no significant patient preference 
for the Isolite or cotton roll isolation. 
Research questions/objectives
The goals of this study are to determine if 1) placement times of pit and 
fissure sealants using the DryShield system differ from those when using the cotton 
roll isolation technique; and 2) there is a significant difference in patient preference 
between Dryshield and the cotton roll technique. 
Study design
This is a split-mouth, randomized controlled trial study. When patients 
meeting the inclusion criteria arrive for their sealants application appointment at 
one of the four pediatric dental clinics of Montefiore, the study protocol will be 
explained, and patients and parents will be given the option of participating.  Once 
the informed consent has been obtained (patient assent and parental consent), the 
patients will be randomized into four groups with randomization ratio 1:1:1:1, with 
each patient acting as their own control. The four groups are a result of randomizing 
the side receiving one of the interventions (CRI v. DS) as well as the order of 
application (first v. second).  Randomization will be determined using a random 
number generator in SAS, that will produce envelope inserts with the allocation 
codes for that subject. Sealed envelopes containing inserts will be labeled with 
sequential numbers and the next envelope in the sequence will be opened in 
conjunction with the next subject who qualifies.    The four groups are:
Group 1) Sealants placement using CRI on the left side, followed by sealants 
placement using DS on the right side
Group 2) Sealants placement using CRI on the right side, followed by 
sealants placement using DS on the left side
Group 3) Sealants placement using DS on the left side, followed by sealants 
placement using CRI on the right side
Group 4) Sealants placement using DS on the right side, followed by sealants 
placement using CRI on the left side
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One operator will apply all the pits and fissure sealants in a given subject. 
Subjects
The target population will include healthy (ASA I/II), deemed able to 
cooperate children who present to one of the Montefiore pediatric dental clinics for 
an intake or a recall visit who are determined to benefit from sealants application, 
or patients who present solely for a sealant application appointment, when their 
examination was done at a previous date (within 6 months).  The sample of patients 
will range from 5 to 14 years of age. They will be selected based on their cooperative 
behavior displayed during their visit or recorded at the previous encounter 
(classified as 3 or 4 according to the Frankl Behavioral Rating Scale). Patients 
included in the study need to have at least one erupted caries-free permanent molar 
in each quadrant.  Subjects must be able to speak English or Spanish. There will be 
no exclusions based on race, gender, and ethnicity. Uncooperative, medically 
compromised patients requiring fewer than four sealants on permanent molars will 
be excluded. Those who do not provide appropriate assents or consents will be 
excluded. There are no risks nor benefits for participating in that study.  Children 
participating will only benefit from the sealants application planned as part of their 
treatment.
Study procedures
When presenting for their scheduled intake or recall appointments, and it 
has been determined during the examination that the patient would benefit from 
sealants application, parents of potential subjects meeting the inclusion criteria will 
be asked if they would like their child to participate in the study.  The same will be 
done for patients coming exclusively for their sealants placement. Informed 
consents and assents will be obtained at the time of the visit targeted for sealants 
placement.   One operator will apply all the pits and fissure sealants in a given 
subject with the help of a dental assistant. In each patient, the DS and the CRI will be 
used to seal maxillary and mandibular molars (either on the left or right side, first or 
second).  The correct size of the autoclavable DS mouthpiece will be picked 
according to the manufacturer’s recommended guidelines. 
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In the DS group, no other suction device will be used. In the CRI intervention, a Molt 
mouth prop will be used to help the patients keep their mouth open; an assistant 
will handle a high-speed suction as well as a saliva ejector. 
After the molars are isolated, the technique used for sealant application will 
be exactly the same for both isolation systems. The teeth will be cleaned using a 
prophylaxis cup and pumice, rinsed thoroughly, etched with 40% phosphoric acid 
gel for 15 seconds, rinsed thoroughly, air dried, and sealed with Embrace Wetbond 
pit and fissure sealant by Pulpdent as per standard protocol, and light cured for 20 
seconds. Following placement and curing, the sealants will be checked for proper 
retention and voids with an explorer.  In the case of any voids, defects or material 
dislodgement, the results will be recorded and the sealant reapplied. The time for 
sealant application will be recorded with a stopwatch by the dental assistant as 
follows for the two techniques:  the insertion of the isolation aids (DS or CRI) in the 
oral cavity will constitute the start time, and the end time will coincide with the time 
when the isolation aids are removed from the oral cavity after the sealants 
application.  
A seven-item survey will be used to evaluate patients’ acceptance and 
satisfaction of CRI and DS. This modified close-ended questionnaire was previously 
developed and used in a study, which evaluated the efficacy and patient satisfaction 
associated with the use of Isolite and CRI by Colette et Al. The items will reflect 
issues of comfort, noise, taste, tissue stretching.  The pediatric dental attending will 
ask the patient each question verbally in the same sequence at the end of the visit. 
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Patient’s preference questionnaire: Cotton roll isolation vs DryShield
Date:  MM/DD/YY
Child ID:
Start time of DS:                        End time of DS:
Start time of CRI:                       End time of CRI:
Randomization Group:                      
Please circle the appropriate answer (to be read to subject):
1.
Which system made the most noise?
CRI
DS
2.
Which system stretched your mouth, cheeks, and lips the most?
CRI
DS
3.
Which system was the most comfortable
CRI
DS
4.
If we did the procedure again, which system would you prefer?
CRI
DS
5.
Did either system made you feel as if you needed to gag?
If yes, which system made you feel like you needed to gag the most
No
CRI
Yes
DS
6.
Did you taste any of the materials used?
If yes, with which system did you taste the materials the most?
No
CRI
Yes
DS
7.
Did either system cause any discomfort?
If yes, which system caused the most discomfort?
No
CRI
Yes
DS
Statistical analysis
Estimates of the mean time to completion of the procedure were 398 for CRI and 
340 for IS (Collette, 2009).  Because the within subject standard deviation was not 
provided in the Collette 2009 and Lyman 2012 articles, we assumed a standard 
deviation for the paired/split-mouth design between CRI and IS to be 100 seconds.  
For an overall α=.05 (as per Lyman) considering two main hypotheses (DS v. CRI; 
right v. left), then 31 subjects are required for a two-tailed test with 80% power. It is 
expected that the distribution of differences from right to left, as per a split-mouth 
randomized design, will be somewhat normally distributed and CRI .
Descriptive statistics will be presented as means and standard deviations for 
normally distributed data, or medians and ranges if continuous and nonnormal. 
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Relative frequencies will be presented for dichotomous variables by group, 
intervention order and side. The statistical analysis is similar to that for a cross-over 
design in which a side by treatment interaction and first/second application by 
treatment interaction have to be considered in the analysis. The analysis will be 
done using a general linear model that accounts for pairing within subject and the 
interactions described. Preferences for treatment will be presented as proportions 
along with 95% or 99% confidence intervals as per the predetermined α level.
Implementation plan/timetable
The researcher will perform enrollment of subjects, obtain informed consent and 
assent, collect data, and perform data entry, management and analysis. Subjects will 
be enrolled at each of four Montefiore Pediatric Dental Clinics, including 1516 
Jarrett Place, 5500 Broadway, 951 Prospect Avenue, and 3444 Kossuth Avenue. 
Numbers will be assigned to each patient to ensure patient privacy and all other 
identifiers will be removed. Patient enrollment and data collection will begin once 
IRB approval is obtained
References: 
1. National Center for Health Statistics. Center for Disease control and 
Prevention. Dental Caries and Sealant Prevalence in Children and 
Adolescents in the United States, 2011-2012.   
http://www.cdc.gov/nchs/data/databriefs/db191.htm. Accessed Sept 2016
2. Beauchamp J, Caufield PW, Crall JJ, et al. Evidence-based clinical 
recommendations for the use of pit-and-fissure sealants: a report of the 
American Dental Association Council on Scientific Affairs. J Am Dent Assoc 
2008; 139: 257-268.
3. Ahovuo-Saloranta A, Hijri A, NOrdblad A, Worthington H, Makela M. Pit and 
fissure sealants for preventing dental decay in the permanent teeth of 
children and adolescents. Cochrane Database Syst Rev 2004(3): CD001830.
4. Weintraub? 
5. Ripa LW; Gwinnett AJ
6. Lyman T, Viswanathan K, McWhorter A. Isolite Vs Cotton roll isolation in the 
placement of dental sealants. Pediatr Dent 2013; 35: E95-E99
7. Primosch RE, Barr ES. Sealant use and placement techniques among pediatric 
dentists. J Am Dent Assoc 2001; 132: 1442-51; quiz 61
8. Silverstone LM
9. Colette J, Wilson S, Sullivan D. A study of the Isolite System during Sealant 
Placement: efficacy and Patient Acceptance. Pediatr Dent 2010; 32 :146-50
Other reference: AlharekyM, Mermelstein D, Finkelman M et al. Efficiency 
and patient satisfaction with the Isolite system vs rubber dam for sealant 
placement in pediatric patients. Pediatr Dent 2014; 36:400-4
IRB NUMBER: 2016-7229
IRB APPROVAL DATE: 01/17/2017

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IRB NUMBER: 2016-7229
IRB APPROVAL DATE: 01/17/2017