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

NCT02995369 | Completed Results

• 1 other identifier: 2016-7229
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Time; Patient Preference

Keywords

Sealants; Dryshield; Cotton roll; Isolation; Efficiency; Preference

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Cotton Roll Isolation (left), then DryShield Isolation (right)

EXPERIMENTAL

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).

Device: DryShield; Other: Cotton rolls

Cotton Roll Isolation (right), then DryShield Isolation (left)

EXPERIMENTAL

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).

Device: DryShield; Other: Cotton rolls

DryShield Isolation (left), then Cotton Roll Isolation (right)

EXPERIMENTAL

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).

Device: DryShield; Other: Cotton rolls

DryShield Isolation (right), then Cotton Roll Isolation (left)

EXPERIMENTAL

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).

Device: DryShield; Other: Cotton rolls

Interventions

DryShield DEVICE

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.

Cotton Roll Isolation (left), then DryShield Isolation (right); Cotton Roll Isolation (right), then DryShield Isolation (left); DryShield Isolation (left), then Cotton Roll Isolation (right); DryShield Isolation (right), then Cotton Roll Isolation (left)

Cotton rolls OTHER

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.

Cotton Roll Isolation (left), then DryShield Isolation (right); Cotton Roll Isolation (right), then DryShield Isolation (left); DryShield Isolation (left), then Cotton Roll Isolation (right); DryShield Isolation (right), then Cotton Roll Isolation (left)

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (5)

• 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.

  PMID: 20483019 BACKGROUND

• 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.

  PMID: 25303507 BACKGROUND

• 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.

  PMID: 18310730 BACKGROUND

• 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.

  PMID: 23756302 BACKGROUND

• 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.

  PMID: 11680361 BACKGROUND

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Nuntiya Kakanantadilok
• Organization: Montefiore Medical Center

nkakanan@montefiore.org

718-405-8057

Study Officials

• Nuntiya Kakanantadilok, DMD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Division of Pediatric Dentistry

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: January 17, 2017
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: January 20, 2023
• Results First Posted: January 20, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)