COES: Curing Order Effects on Sealants

Phase 1

Recruiting

• Conditions: Dental Sealant; Sealant Retention
• Interventions: Drug: Ultradent Ultra Seal XT Plus

• Registration Number: NCT06342258
• Lead Sponsor: University of Southern California

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-02-23
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Status Verified: 2024-04
• Study First Posted: 2024-04-02
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 217

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Heads	Ultradent Ultra Seal XT Plus	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	Ultradent Ultra Seal XT Plus	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.

Primary Outcome Measures

Name	Time	Method
Sealant Longevity	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Caries	2 years	Secondary objectives of this study aim to look at caries incidence of sealed permanent molars, by monitoring recurrent caries under sealant placement.
Molar hypomineralization	2 years	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.

Trial Locations

Locations (1)

Herman Ostrow School of Dentistry of USC; 🇺🇸 Los Angeles, California, United States