Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Delta Dental of Iowa | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isolite System | Other | The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement. |
|
| Cotton Roll technique | Other | A cotton roll is placed between the cheek and tongue prior to sealant placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isolite System | Device |
| ||
| Cotton Roll Technique |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shin | Director of Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa College of Dentistry and Dental Clinics | Iowa City | Iowa | 52242 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 104 enrolled subjects, 104 met the inclusion criteria and were randomized to treatment.
Subjects were recruited from the Pediatric Dentistry Clinic at the University of Iowa College of Dentistry and Dental Clinics.
| ID | Title | Description |
|---|---|---|
| FG000 | Isolite System | The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement. |
| FG001 | Cotton Roll System | A cotton roll is placed between the cheek and tongue prior to sealant placement. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Units | teeth | 12 months after treatment | teeth | teeth |
|
Adverse events were collected over a 12 month time-period
no adverse events were reported
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Isolite® Technique Device | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | University of Iowa College of Dentistry | 319-467-1398 | dentistry-research@uiowa.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2019 | Sep 1, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| C536528 | Van der Woude syndrome |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Triple:
Participants, Investigator, and Outcome assessors do not know the randomization. However, it was hard to blind the care provider.
|
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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 |
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Cotton Roll Technique Device | 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 | 0 | 99 | 0 | 99 | 0 | 99 |
Not provided
Not provided