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

• Sponsor: University of Iowa (Other)
• Overall Status: Completed
• CT.gov ID: NCT02668874
• Collaborator: Delta Dental of Iowa (Other)
• Enrollment: 104
• Location: 1
• Arms: 2
• Duration (Months): 30.6
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries on Pit and Fissure Surface	Device: Isolite System; Other: Cotton Roll Technique	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Simple randomization will be used for assignment of the treatment groups. Randomization: Two application methods will be used in each subject in order to place sealants, one using the Isolite system and one using the cotton roll system.Simple randomization will be used for assignment of the treatment groups. Randomization: Two application methods will be used in each subject in order to place sealants, one using the Isolite system and one using the cotton roll system.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Triple: Participants, Investigator, and Outcome assessors do not know the randomization. However, it was hard to blind the care provider.
• Primary Purpose: Treatment
• Official Title: A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Aug 21, 2017
• Actual Study Completion Date: Aug 21, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Sealant Retention Percentage at 12 Months After Treatment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa College of Dentistry and Dental Clinics	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• University of Iowa
• Delta Dental of Iowa

Investigators

• Study Director: Shin, Director of Clinical Research

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 1, 2019

More Information

Publications

None provided.

• Responsible Party: University of Iowa
• ClinicalTrials.gov Identifier: NCT02668874
• Other Study ID Numbers: 201502801
• First Posted: Jan 29, 2016
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by University of Iowa: Pit and Fissure sealants; Isolation; permanent teeth; children; Isolite®; Dental caries
• Additional relevant MeSH terms: Dental Caries

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from the Pediatric Dentistry Clinic at the University of Iowa College of Dentistry and Dental Clinics.
Pre-assignment Detail	Of the 104 enrolled subjects, 104 met the inclusion criteria and were randomized to treatment.

Arm/Group Title	Isolite System	Cotton Roll System
Arm/Group Description	The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.	A cotton roll is placed between the cheek and tongue prior to sealant placement.
Period Title: Overall Study
STARTED	104	104
6 Months After Placement	59	59
COMPLETED	47	47
NOT COMPLETED	57	57

Baseline Characteristics

Arm/Group Title	Overall Group
Arm/Group Description	The Isolite® technique differs in that it utilizes a flexible plastic dental adapter to separate the teeth from the cheek and tongue. The resident dentist will show the child the Isolite® before it is placed in the mouth. The resident with whom the child is scheduled will then apply the sealants. Isolite® technique: The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant application.
Overall Participants	103
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.57 (3.12)
Sex/Gender, Customized (Count of Participants)
Female	48 46.6%
Male	51 49.5%
Unknown	4 3.9%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Sealant Retention Percentage at 12 Months After Treatment
Description	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.
Time Frame	12 months after treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Isolite® Technique Device	Cotton Roll Technique Device
Arm/Group Description	The Isolite® technique differs in that it utilizes a flexible plastic dental adapter to separate the teeth from the cheek and tongue. The resident dentist will show the child the Isolite® before it is placed in the mouth. The resident with whom the child is scheduled will then apply the sealants. Isolite® technique: The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant application.	The resident dentist with whom the child is scheduled with apply the sealants after the cotton roll technique has been placed. Cotton Roll technique: A cotton roll is placed between the cheek and tongue prior to sealant application
Measure Participants	47	47
Measure teeth	82	82
Count of Units [teeth]	59	66

Adverse Events

Time Frame	Adverse events were collected over a 12 month time-period
Adverse Event Reporting Description	no adverse events were reported
Arm/Group Title	Isolite® Technique Device		Cotton Roll Technique Device
Arm/Group Description	The Isolite® technique differs in that it utilizes a flexible plastic dental adapter to separate the teeth from the cheek and tongue. The resident dentist will show the child the Isolite® before it is placed in the mouth. The resident with whom the child is scheduled will then apply the sealants. Isolite® technique: The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant application.		The resident dentist with whom the child is scheduled with apply the sealants after the cotton roll technique has been placed. Cotton Roll technique: A cotton roll is placed between the cheek and tongue prior to sealant application
All Cause Mortality
	Isolite® Technique Device		Cotton Roll Technique Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/99 (0%)
Serious Adverse Events
	Isolite® Technique Device		Cotton Roll Technique Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/99 (0%)
Other (Not Including Serious) Adverse Events
	Isolite® Technique Device		Cotton Roll Technique Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/99 (0%)		0/99 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.