Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background: Sealants are a great tool in the prevention of caries in the pediatric population. It has been shown that up to 71% of occlusal decay is preventable after a single sealant application in a fissure, and thus is the standard of care due to difficulty for pediatric patients in hygiene, diet, and overall home care until manual dexterity increases.
Purpose: This prospective randomized case control study aims to look at the longevity of sealants with bonding agent cured prior to sealant placement vs those with uncured bond. The study will be performed by USC graduate pediatric personnel.
Methods: A split mouth prospective randomized control study will be performed on pediatric dental patients at Long Beach Memorial's Children's Dental Health Clinic and USC Pediatric Dental Clinic, placing sealants with cured bond on half of a mouth and sealants with uncured bond on the contralateral half. Intraoral photos will be obtained at the initial visit and recalls to evaluate the overall retention/longevity of the sealant placement. The goal of this study is determine which sealant has higher longevity and to provide recommendations for future pediatric dentists regarding sealant procedures.
The primary objective of this prospective randomized control trial is to test the longevity of pit and fissure resin sealants placed with cured bonding agent compared to resin sealants placed with uncured bonding agent over a 2 year period. Sealants will be evaluated at 6 month recall visits (6 month recall, 12 month recall, 18 month recall and 24 month recall), as determined by comparing time lapse intraoral photos and clinical examinations. Secondary objectives of this study aim to look at caries incidence of sealed permanent molars, by monitoring recurrent caries under sealant placement. Additionaly looking at sealant longevity of pit and fissure sealants of hypomineralized versus non hypomineralized molar, classified using Mathu-Muju Wright Classification, with only mildly hypomineralized molars being utilized for the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heads | Experimental | Heads indicates the RIGHT side of mouth WILL be cured prior to sealant placement. The left side of the mouth will have bond and sealant cured together after. |
|
| Tails | Experimental | Tails indicates the LEFT side of the mouth WILL be cured prior to sealant placement. The right side of the mouth will not have bond cured prior to sealant placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultradent Ultra Seal XT Plus | Drug | Each child who has erupted, bilateral permanent molars that qualify for the study and agree to participate will have a side (right or left side) of their mouth randomized for bond that will be cured prior to sealant placement. Daily flossing and oral hygiene instructions will be taught to patients of all study groups. Sealant will be placed using a dental suction isolation system, such as DryShield isolation after prophy cup polish with pumice. No enameloplasty will be conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| Sealant Longevity | The primary outcome is measuring sealant longevity with intraoral photos and clinical exams. The outcome will be measured as retention (yes/no) and will be evaluated at 4 time points: 6 months, 12 months, 18 months, and 24 months as compared to initial baseline photos taken at treatment day. Patients/parents will be blinded to treatment status. The evaluation of intraoral photos will be performed by blinded practitioners. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Caries | Secondary objectives of this study aim to look at caries incidence of sealed permanent molars, by monitoring recurrent caries under sealant placement. | 2 years |
| Molar hypomineralization |
Not provided
Inclusion Criteria:
Exclusion Criteria
Withdrawal Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Pham, DDS | Contact | 2137400412 | cathph@ostrow.usc.edu | |
| Grace Kim, DDS | Contact | 8604055915 | gchung34@usc.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herman Ostrow School of Dentistry of USC | Recruiting | Los Angeles | California | 90089 | United States |
Not provided
After baseline examination, a randomized generator, will be used in order to issue which side will bonding agent cured prior to sealant placement. Randomization will be a simple randomization, and will be determined by the provider flipping a coin. Randomization will be performed to ensure graders of sealants will be blinded to which side of bond is cured prior to sealant placement.
Heads indicates the RIGHT side of mouth WILL be cured prior to sealant placement. The left side of the mouth will have bond and sealant cured together after.
Tails indicates the LEFT side of the mouth WILL be cured prior to sealant placement. The right side of the mouth will not have bond cured prior to sealant placement.
Not provided
Not provided
Not provided
|
Sealant longevity of pit and fissure sealants of hypomineralized versus non hypomineralized molar, classified using Mathu-Muju Wright Classification, with only mildly hypomineralized molars being utilized for the study.
| 2 years |