Evaluating the effectiveness of different bonding agents for dental sealants in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to compare the longevity of dental sealants applied with cured bonding agents versus uncured bonding agents in pediatric patients. Conducted by graduate pediatric personnel at the University of Southern California, the study will utilize a split-mouth design where sealants will be placed on one side of the mouth with a cured bond and on the opposite side with an uncured bond. Participants will be monitored over a two-year period with regular recall visits to assess sealant retention and caries incidence through intraoral photos and clinical examinations.

Why it matters

Who can join: the full rules

Inclusion 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.

Exclusion Criteria

* 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* Any tooth which has progression of caries beyond ICCMS Category 3 will be withdrawn from the study.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* Any qualifying tooth that subsequently requires a restoration due to trauma will be withdrawn from the study.
* Any patient with an adverse reaction to treatment will be withdrawn.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.

Where it's running

• Herman Ostrow School of Dentistry of USC
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Catherine Pham, DDS
• Email: cathph@ostrow.usc.edu
• Phone: 2137400412

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using deproteinizing agents before fissure sealants on lower primary molars

  This trial tests whether applying deproteinizing agents like sodium hypochlorite or hypochlorous acid before placing fissure sealants improves sealant success in healthy children aged 4–6.

  Recruiting Tokat Gaziosmanpasa University · Tokat Province · NCT07003958

• Investigating how different agents affect the success of fissure sealants in children's teeth

  This study is testing different treatments to see which one helps sealants work better on new back teeth in kids aged 6 to 9 to prevent cavities.

  Recruiting Tokat Gaziosmanpasa University · Tokat Province · NCT06988098

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.