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New treatment option for Dental Sealant
Official title COES: Curing Order Effects on Sealants
ClinicalTrials.gov ID: NCT06342258
What this study is testing
What is Ultradent Ultra Seal XT Plus?
Ultradent Ultra Seal XT Plus is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for dental sealant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 14. Healthy volunteers may be eligible.
You may be able to join if
- ASA I and ASA II children, aged 5 to 14 years who are patients of CDHC and USC with adequate eruption of permanent first or second molars for...
- These teeth will not have previous restorations, interproximal lesions, pathology, or occlusal lesions.
- Behavior of the children should be within a Frankl 3 or 4 category, indicating a "positive" and "Definitely Positive" behavior rating, which would...
- Patient must have contralateral molars in the same arch in which sealants can be placed. For example a child with #30 and #19 present will qualify...
You likely can't join if
- Any tooth with previous sealant placement
- Children who are allergic or intolerant to sealant material
- Children who cannot tolerate a dental suction isolation system, such as DryShield isolation
- Children who do not complete a prophy cup polish.
- Children who present with banded or bracketed molars
- Patients or Parents who cannot fully understand an English or Spanish Consent/ Assent form. Withdrawal Criteria
See the full eligibility criteria
- ASA I and ASA II children, aged 5 to 14 years who are patients of CDHC and USC with adequate eruption of permanent first or second molars for placement of sealants
- These teeth will not have previous restorations, interproximal lesions, pathology, or occlusal lesions.
- Behavior of the children should be within a Frankl 3 or 4 category, indicating a "positive" and "Definitely Positive" behavior rating, which would allow for safe and controlled execution of the proposed protocol
- Patient must have contralateral molars in the same arch in which sealants can be placed. For example a child with #30 and #19 present will qualify for the study.
- Any tooth with previous sealant placement
- Children who are allergic or intolerant to sealant material
- Children who cannot tolerate a dental suction isolation system, such as DryShield isolation
- Children who do not complete a prophy cup polish.
- Children who present with banded or bracketed molars
- Patients or Parents who cannot fully understand an English or Spanish Consent/ Assent form. Withdrawal Criteria
- Patients can withdraw voluntarily at any time.
- Any tooth which has progression of caries beyond ICCMS Category 3 will be withdrawn from the study. These teeth will be treated with appropriate restorative dental treatment according to the standard of care.
- Any qualifying tooth that subsequently requires a restoration due to trauma will be withdrawn from the study.
- Any patient with an adverse reaction to treatment will be withdrawn. This event will be reported to the IRB.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 14 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.