Dental Sealants for Pediatric Patients

(COES Trial)

Overseen By Grace Kim, DDS

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Southern California

Disqualifiers: Previous sealants, Allergies, Brackets, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

217 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Ultradent Ultra Seal XT Plus for preventing cavities in children?

Research shows that Ultradent Ultra Seal XT Plus, a type of pit-and-fissure sealant, has a high retention rate, meaning it stays on the teeth well, with 92.7% retention after 6 months and 79.9% after 2 years. This suggests it is effective in preventing cavities in children's molars. ^{1 2 3 4 5}

Is it safe to use dental sealants like UltraSeal XT Plus in children?

Studies show that dental sealants like UltraSeal XT Plus are safe for use in children, with no reported harmful side effects over two years of monitoring. ^{1 3 4 6 7}

What makes Ultradent Ultra Seal XT Plus unique as a treatment for dental sealants in children?

Ultradent Ultra Seal XT Plus is unique because it has a high retention rate, meaning it stays on the teeth longer, which helps prevent cavities effectively. It also combines the benefits of both hydrophilic (water-attracting) and hydrophobic (water-repelling) properties, making it more adaptable to different conditions in the mouth. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for pediatric patients who need dental sealants to prevent tooth decay. The study will be conducted by USC graduate pediatric personnel at specific clinics, and participants must have teeth suitable for sealant application.

Inclusion Criteria

My child is cooperative and responds well in medical settings.

I am a child aged 5-14 with healthy molars suitable for sealants.

I have opposite side back teeth suitable for sealant placement.

Exclusion Criteria

Children who cannot tolerate a dental suction isolation system, such as DryShield isolation

My child has not completed a dental cleaning with polishing.

Patients or Parents who cannot fully understand an English or Spanish Consent/Assent form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Sealants are placed with cured bonding agent on one side of the mouth and uncured on the other side, with intraoral photos taken at the initial visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for sealant retention and caries incidence at 6-month intervals

24 months

4 visits (in-person) at 6, 12, 18, and 24 months

Treatment Details

Interventions

• Ultradent Ultra Seal XT Plus

Trial Overview The COES study tests the longevity of two methods of applying a dental sealant called Ultradent Ultra Seal XT Plus: one with bonding agent cured before placing the sealant versus one with uncured bond. It's a controlled test where each child gets both treatments on different halves of their mouth.

Participant Groups

Group I: Tails Experimental Treatment 1 Intervention

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.

Group II: Heads Experimental Treatment 1 Intervention

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.

Ultradent Ultra Seal XT Plus is already approved in United States, European Union for the following indications:

Approved in United States as Pit-and-fissure sealants for:

• Prevention of occlusal caries in children and adolescents

Approved in European Union as Pit-and-fissure sealants for:

• Prevention of occlusal caries in children and adolescents

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Findings from Research

The Ultra Seal XT light-cured fissure sealant demonstrated high retentivity over two years, with 92.7% retention after 6 months, 87.8% after 1 year, and 79.9% after 2 years, indicating its effectiveness in preventing cavities in children's molars.

This study, involving 112 Hungarian school-children and a total of 247 sealed molars, supports the use of modern fissure sealants as a reliable preventive measure in pediatric dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Retention of Ultra Seal XT third generation fissure sealant in systematic pedodontic care]. Rózsa, N., Tarján, I., Gábris, K.[2006]

A clinical trial involving 148 children demonstrated that a clearly visible white pit and fissure sealant is effective in protecting teeth.

The three-year follow-up study revealed a high retention rate for the sealant, indicating its long-term efficacy in preventing dental issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of a colored pit and fissure sealant at 36 months. Simonsen, RJ.[2019]

Pit-and-fissure sealants are effective in preventing and stopping the development of cavities on the occlusal surfaces of primary and permanent molars in children and adolescents, outperforming both no treatment and fluoride varnishes.

Sealants can also help slow down the progression of early, non-cavitated carious lesions, but there is not enough evidence to recommend one type of sealant material over another.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based Clinical Practice Guideline for the Use of Pit-and-Fissure Sealants. [2022]

Pit-and-fissure sealants are effective in preventing and stopping the development of cavities on the occlusal surfaces of primary and permanent molars in children and adolescents, outperforming both no treatment and fluoride varnishes.

Sealants can also help slow down the progression of early, non-cavitated carious lesions, but there is not enough evidence to recommend one type of sealant material over another.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Pit-and-Fissure Sealants. [2022]

Pit-and-fissure sealants are effective in preventing and stopping the development of cavities on the occlusal surfaces of primary and permanent molars in children and adolescents, outperforming both no treatment and fluoride varnishes.

Sealants can also help prevent the progression of early, non-cavitated carious lesions, but there is insufficient evidence to recommend one type of sealant material over another.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based Clinical Practice Guideline for the Use of Pit-and-Fissure Sealants. [2018]

In a study involving 470 sealants placed on adolescent patients' permanent molars and premolars, the long-term retention rates after two years were 96.3% for UltraSeal XT and 91.4% for FluoroShield, indicating high effectiveness of these fluoride-containing sealants.

Remarkably, there were no new carious lesions in the pits and fissures over the two-year period, demonstrating that these sealants not only retained well but also effectively prevented cavities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year retention and caries rates of UltraSeal XT and FluoroShield light-cured pit and fissure sealants. Boksman, L., Carson, B.[2013]

In a study involving 30 schoolchildren aged 12-15, the conventional Clinpro™ 3M™ ESPE™ sealant demonstrated a significantly higher retention rate (59%) compared to the hydrophilic Ultraseal XT Hydro sealant (27.27%) after 6 months.

Clinpro™ also showed a better cariostatic effect, with a lower incidence of caries compared to Ultraseal XT Hydro, indicating that Clinpro™ is more effective in preventing cavities in pits and fissures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison and Evaluation of the Retention, Cariostatic Effect, and Discoloration of Conventional Clinpro 3M ESPE and Hydrophilic Ultraseal XT Hydro among 12-15-year-old Schoolchildren for a Period of 6 Months: A Single-blind Randomized Clinical Trial. Mohapatra, S., Prabakar, J., Indiran, MA., et al.[2022]

The new hydrophilic fissure sealant, UltraSeal XT® hydro™, demonstrated a significant reduction in microleakage when applied to molars that were preconditioned with laser treatment, indicating improved sealing effectiveness.

Characterization of the sealant revealed it has a moderate degree of conversion and microhardness, with a unique composition that enhances its performance when used on laser-treated enamel surfaces.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterisation and microleakage of a new hydrophilic fissure sealant - UltraSeal XT® hydro™. Güçlü, ZA., Dönmez, N., Hurt, AP., et al.[2019]

In a study of 32 posterior teeth, the sealants Clinpro and Concise demonstrated effective penetration and adaptation to the enamel, which is crucial for preventing cavities, while Fissurit and Fissurit F showed gaps and voids at the sealant-enamel interface.

The research highlights that while sealants are effective for caries prevention, their success relies on proper oral hygiene and regular dental check-ups to maintain their protective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marginal seal evaluation of different resin sealants used in pits and fissures. An in vitro study. Montanari, M., Pitzolu, G., Felline, C., et al.[2019]

References

1. Hungary pubmed.ncbi.nlm.nih.gov

[Retention of Ultra Seal XT third generation fissure sealant in systematic pedodontic care]. [2006]

2. England pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of a colored pit and fissure sealant at 36 months. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence-based Clinical Practice Guideline for the Use of Pit-and-Fissure Sealants. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Use of Pit-and-Fissure Sealants. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evidence-based Clinical Practice Guideline for the Use of Pit-and-Fissure Sealants. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Two-year retention and caries rates of UltraSeal XT and FluoroShield light-cured pit and fissure sealants. [2013]

7. India pubmed.ncbi.nlm.nih.gov

Comparison and Evaluation of the Retention, Cariostatic Effect, and Discoloration of Conventional Clinpro 3M ESPE and Hydrophilic Ultraseal XT Hydro among 12-15-year-old Schoolchildren for a Period of 6 Months: A Single-blind Randomized Clinical Trial. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Characterisation and microleakage of a new hydrophilic fissure sealant - UltraSeal XT® hydro™. [2019]

9. Italy pubmed.ncbi.nlm.nih.gov

Marginal seal evaluation of different resin sealants used in pits and fissures. An in vitro study. [2019]