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DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status

Completed

Conditions

Time
Patient Preference

Treatments

Other: Cotton rolls
Device: DryShield

Study type

Interventional

Funder types

Other

Identifiers

NCT02995369
2016-7229

Details and patient eligibility

About

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.

Full description

Pit and fissure caries account for 80 to 90 percent of all caries in permanent posterior teeth. 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. 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 critical. Low retention of sealants has been attributed to insufficient moisture control. Therefore, proper isolation of the teeth is one of the most important steps when placing sealants to ensure their retention. Cotton roll isolation (CRI) has been widely used for sealant placement, and is the most common method among pediatric dentists. 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 clinician. A previous study demonstrated that new moisture control systems such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while decreasing procedure time. 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.

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.

Enrollment

32 patients

Sex

All

Ages

5 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The target population will include healthy, cognitively normal patients 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 completed at a previous date (within 6 months).

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) Classification I or II
  • Ages 5 to 14 years
  • Cooperative behavior at present visit or recorded at the previous encounter (classified as 3 or 4 on the Frankl Behavioral Rating Scale).
  • At least one erupted caries-free permanent molar in each quadrant
  • Ability able to speak and understand English or Spanish
  • There will be no exclusions based on race, gender, and ethnicity.

Exclusion Criteria:

  • ASA Classification III or higher
  • Uncooperative behavior at present visit or recorded at the previous encounter (classified as 1 or 2 on the Frankl Behavioral Rating Scale).
  • Patients who require less than four sealants on permanent molars
  • Patients who do not provide assent or consent.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 4 patient groups

Cotton Roll Isolation (left), then DryShield Isolation (right)
Experimental group
Description:
Cotton rolls (CRI) will be used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using Dryshield (DS) on the opposite side. 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).
Treatment:
Device: DryShield
Other: Cotton rolls
Cotton Roll Isolation (right), then DryShield Isolation (left)
Experimental group
Description:
Cotton rolls (CRI) will be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using DryShield (DS) on the opposite side. 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).
Treatment:
Device: DryShield
Other: Cotton rolls
DryShield Isolation (left), then Cotton Roll Isolation (right)
Experimental group
Description:
DryShield (DS) will be used to isolate the maxillary and mandibular teeth on the left side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side. 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).
Treatment:
Device: DryShield
Other: Cotton rolls
DryShield Isolation (right), then Cotton Roll Isolation (left)
Experimental group
Description:
DryShield (DS) will be used to isolate the maxillary and mandibular teeth on the right side of the mouth, followed by sealants placement using cotton rolls (CRI) on the opposite side. 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).
Treatment:
Device: DryShield
Other: Cotton rolls

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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