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

Not Applicable

Completed

Conditions: Patient Preference
Time

Interventions: Device: DryShield
Other: Cotton rolls

Registration Number: NCT02995369

Lead Sponsor: Montefiore Medical Center

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cotton Roll Isolation (right), then DryShield Isolation (left)	Cotton rolls	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).
DryShield Isolation (right), then Cotton Roll Isolation (left)	Cotton rolls	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).
Cotton Roll Isolation (right), then DryShield Isolation (left)	DryShield	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).
DryShield Isolation (right), then Cotton Roll Isolation (left)	DryShield	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).
Cotton Roll Isolation (left), then DryShield Isolation (right)	DryShield	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).
Cotton Roll Isolation (left), then DryShield Isolation (right)	Cotton rolls	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).
DryShield Isolation (left), then Cotton Roll Isolation (right)	DryShield	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).
DryShield Isolation (left), then Cotton Roll Isolation (right)	Cotton rolls	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).

Primary Outcome Measures

Name	Time	Method
Patient Preference as Assessed by Verbal Self-report Survey	Immediately after the dental procedure is completed, up to 30 minutes	Right after the procedure, participants completed a verbal survey. The survey consisted of seven closed-ended questions intended to assess the participants' opinion on things such as comfort, noise, taste, and tissue stretching. Some survey questions require a YES or NO answer (i.e. Did you taste any of the materials used?). Other questions required the participant to select CRI or DS (i.e. Which system was the most comfortable?). The pediatric dental attending asked each patient each question, in the same sequence. Patient preferences were assessed with Question number 4, which specifically asked " If we did the procedure again, which system would you prefer?" The options were the Cotton Roll Isolation (CRI) or the Dryshield (DS) system. The reported values represents the response to Question number 4.
Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)	Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)	The time for sealant application was recorded with a stopwatch by the dental assistant as follows for the techniques: the insertion of the first isolation aid (CRI or DS) in the oral cavity constituted the start time, and the end time was when the corresponding isolation aid (CRI or DS) was removed from the oral cavity after the sealants application.

Secondary Outcome Measures