Recruiting
Phase 1

Observational Study

Sponsor:

University of Southern California

Code:

NCT06342258

Conditions

Dental Sealant

Sealant Retention

Eligibility Criteria

Sex: All

Age: 5 - 14

Healthy Volunteers: Accepted

Interventions

Ultradent Ultra Seal XT Plus

Study Details

Brief summary:

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.

Conditions

Dental Sealant

Sealant Retention

Study ID

NCT06342258

Start date

Feb 23, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 14

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

217 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Heads

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.

experimental: Tails

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.

Interventions

Ultradent Ultra Seal XT Plus

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.

Primary outcome measure

  • Sealant Longevity [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Catherine Pham, DDS

2137400412cathph@ostrow.usc.edu

Grace Kim, DDS

8604055915gchung34@usc.edu

Locations

Herman Ostrow School of Dentistry of USC

Recruiting

Los Angeles, California, United States, 90089

Contacts

Catherine Pham, DDS, MPH

2137400412cmpham@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-07-02.