Trial Outcomes & Findings for A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants (NCT NCT02668874)

NCT ID: NCT02668874

Last Updated: 2022-02-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 104 participants
• Primary outcome timeframe: 12 months after treatment
• Results posted on: 2022-02-01

Participant Flow

Subjects were recruited from the Pediatric Dentistry Clinic at the University of Iowa College of Dentistry and Dental Clinics.

Of the 104 enrolled subjects, 104 met the inclusion criteria and were randomized to treatment.

Unit of analysis: teeth

Participant milestones

Measure	Isolite System The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.	Cotton Roll System A cotton roll is placed between the cheek and tongue prior to sealant placement.
Overall Study STARTED	104 203	104 203
Overall Study 6 Months After Placement	59 113	59 113
Overall Study COMPLETED	47 82	47 82
Overall Study NOT COMPLETED	57 121	57 121

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Group n=103 Participants 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.
Age, Continuous	10.57 years STANDARD_DEVIATION 3.12 • n=103 Participants
Sex/Gender, Customized Female	48 Participants n=103 Participants
Sex/Gender, Customized Male	51 Participants n=103 Participants
Sex/Gender, Customized Unknown	4 Participants n=103 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Isolite® Technique Device n=82 teeth 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.	Cotton Roll Technique Device n=82 teeth 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
Sealant Retention Percentage at 12 Months After Treatment	59 teeth	66 teeth

Adverse Events

Isolite® Technique Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cotton Roll Technique Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Research

University of Iowa College of Dentistry

Phone: 319-467-1398

Email: dentistry-research@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place