Dental Caries on Pit and Fissure Surface
Conditions
Keywords
Pit and Fissure sealants, Isolation, permanent teeth, children, Isolite®, Dental caries
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.
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.
Interventions
DEVICEIsolite System
OTHERCotton Roll Technique
Sponsors
Delta Dental of Iowa
University of Iowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
Of the 104 enrolled subjects, 104 met the inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Overall Group 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. | 103 |
| Total | 103 |
Baseline characteristics
| Characteristic | Overall Group | — |
|---|---|---|
| Age, Continuous | 10.57 years STANDARD_DEVIATION 3.12 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Female | 48 Participants | — |
| Sex/Gender, Customized Male | 51 Participants | — |
| Sex/Gender, Customized Unknown | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 99 |
| other Total, other adverse events | 0 / 99 | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 | 0 / 99 |
Outcome results
Primary
Sealant Retention Percentage at 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.
Time frame: 12 months after treatment
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Isolite® Technique Device | Sealant Retention Percentage at 12 Months After Treatment | 59 teeth |
| Cotton Roll Technique Device | Sealant Retention Percentage at 12 Months After Treatment | 66 teeth |