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

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University of Iowa

Status

Completed

Conditions

Dental Caries on Pit and Fissure Surface

Treatments

Device: Isolite System
Other: Cotton Roll Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT02668874
201502801

Details and patient eligibility

About

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.

Full description

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.

Enrollment

104 patients

Sex

All

Ages

6 to 16 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

104 participants in 2 patient groups

Isolite System
Other group
Description:
The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.
Treatment:
Device: Isolite System
Cotton Roll technique
Other group
Description:
A cotton roll is placed between the cheek and tongue prior to sealant placement.
Treatment:
Other: Cotton Roll Technique

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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