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

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

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 Overview

• Status: Completed
• Conditions: Time; Patient Preference
• Intervention / Treatment: Other: Cotton rolls; Device: DryShield

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuntiya Kakanantadilok, DMD; Phone Number: 718-405-8057; Email: nkakanan@montefiore.org
• Study Contact Backup: Name: Samantha Nolte, DMD; Email: snolte@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
      • Contact: Nuntiya Kakanantadilok, DMD; Phone Number: 718-405-8057; Email: nkakanan@montefiore.org
      • Contact: Samantha Nolte, DMD; Email: snolte@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cotton Roll Isolation (left), then DryShield Isolation (right); 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).	Other: Cotton rolls; Cotton Roll Isolation 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.; Device: DryShield; DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Experimental: Cotton Roll Isolation (right), then DryShield Isolation (left); 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).	Other: Cotton rolls; Cotton Roll Isolation 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.; Device: DryShield; DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Experimental: DryShield Isolation (left), then Cotton Roll Isolation (right); 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).	Other: Cotton rolls; Cotton Roll Isolation 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.; Device: DryShield; DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
Experimental: DryShield Isolation (right), then Cotton Roll Isolation (left); 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).	Other: Cotton rolls; Cotton Roll Isolation 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.; Device: DryShield; DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placement Time of Sealants Using Dryshield (DS) vs Cotton Rolls (CRI)	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.	Initial insertion of isolation aid (CRI or DS) and removal of corresponding isolation aid (CRI or DS)
Patient Preference as Assessed by Verbal Self-report Survey	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.	Immediately after the dental procedure is completed, up to 30 minutes

Collaborators and Investigators

• Sponsor: Montefiore Medical Center

Publications and helpful links

General Publications

• Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.
• Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.
• Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. 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 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.
• Lyman T, Viswanathan K, McWhorter A. Isolite vs cotton roll isolation in the placement of dental sealants. Pediatr Dent. 2013 May-Jun;35(3):E95-9.
• Primosch RE, Barr ES. Sealant use and placement techniques among pediatric dentists. J Am Dent Assoc. 2001 Oct;132(10):1442-51; quiz 1461. doi: 10.14219/jada.archive.2001.0061.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): March 23, 2017
• Study Completion (Actual): March 23, 2017

Study Registration Dates

• First Submitted: December 14, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Isolation; Efficiency; Preference; Sealants; Dryshield; Cotton roll
• Other Study ID Numbers: 2016-7229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No