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Completed

NCT Number: NCT02668874

A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants

The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

About this study

104 regular patients at the College of Dentistry Department of Pediatric Dentistry Clinics, ages 6-16 years, will be invited to participate in this study. Matched contralateral pairs of first and second molars and premolars will be randomized to receive sealants with the use of the device (Isolite) for isolation or with the use of cotton roll isolation. All sealants will be placed by pediatric dentistry residents. Sealants will be placed on first and second permanent molars that have a matched contralateral molar requiring a sealant as well. Photographs may be taken of the sealants on the day of placement and at a 6-month and 12 month recalls. Retention of the sealants will be evaluated and scored by calibrated pediatric dentists.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy patients: American Society of Anesthesiologists (ASA) I or II
  • Good cooperation: Frank1 3 or 4
  • Aged between 6-16 years old at the day of sealant placement
  • Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars.

Exclusion criteria

  • Teeth with a history of past or current caries
  • Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies
  • Teeth with clinical or radiographic evidence of pathology
  • Teeth with a history of restoration or sealant
  • Patients who are poorly behaved

Treatment and study plan

Isolite System

Device

Cotton Roll Technique

Other

Primary outcomes

  1. Sealant Retention Percentage at 12 Months After Treatment

    Time frame: 12 months after treatment

    Physical examination will be done in order to determine if there is a percentage difference in retention rate of teeth, specifically 12 months after treatment.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Delta Dental of Iowa

Registry information

Official study title

A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 29, 2016
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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