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

Effects of Cured Bond On Sealant Retention In The Pediatric Population

This study is testing whether dental sealants last longer when applied with a special type of glue in children’s mouths compared to a different kind of glue.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 217 (estimated)
• Ages: 5 Years to 14 Years
• Sex: All
• Sponsor: University of Southern California (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06342258 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 5 to 14 years with adequate eruption of permanent molars and positive behavior ratings.

Not a fit: Patients with previous sealant placements or those who cannot tolerate dental isolation systems may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dental sealant practices, enhancing caries prevention in children.

How similar studies have performed: While similar studies have explored sealant longevity, this specific comparison of cured versus uncured bonding agents is novel.

Eligibility criteria

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 this trial is running

Los Angeles, California

• Herman Ostrow School of Dentistry of USC — Los Angeles, California, United States (RECRUITING)

Study contacts

• Study coordinator: Catherine Pham, DDS

Conditions: Dental Sealant, Sealant Retention