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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which method of applying dental sealants, specifically Ultradent Ultra Seal XT Plus, lasts longer in children. It compares sealants with bonding agents cured (hardened) before application against those that are not. The goal is to identify which method better protects teeth from decay over time. The trial is ideal for children aged 5 to 14 with fully grown first or second molars and no previous dental work or decay on those teeth. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to benefit from new dental care advancements.

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 prior data suggests that these dental sealants are safe for pediatric patients?

Research has shown that Ultradent Ultra Seal XT Plus is a trusted dental sealant for preventing cavities in children's teeth. Dentists frequently use this sealant, and studies confirm its safety for oral use. It produces no known harmful byproducts and does not harm aquatic life, suggesting it is unlikely to be harmful to humans.

This sealant is a composite, which hardens when exposed to a special light. It also releases fluoride, strengthening teeth and making them more resistant to decay. Safety guidelines recommend keeping it out of children's reach before use, but no major health concerns exist once applied.

In summary, Ultradent Ultra Seal XT Plus is safe and widely used as a dental sealant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dental sealant technique being tested because it explores different curing methods that might enhance the effectiveness of sealants in preventing cavities in children. Unlike standard treatments that typically cure the sealant in a uniform manner, this trial investigates whether curing the tooth surface before applying the sealant on one side of the mouth might offer better adhesion and protection. This approach could potentially lead to longer-lasting sealants and improved oral health outcomes for pediatric patients.

What evidence suggests that this trial's treatments could be effective for preventing caries in pediatric patients?

Research has shown that dental sealants, such as Ultradent Ultra Seal XT Plus, effectively prevent cavities in children. Studies have found that sealants can stop up to 71% of decay on chewing surfaces. In this trial, researchers will apply the Ultra Seal XT Plus sealant using different curing techniques on each side of the mouth. The Ultra Seal XT Plus sealant adheres well, with 92.7% remaining intact after six months and 79.9% after two years. Additionally, this sealant releases fluoride, which strengthens teeth and prevents decay. Overall, these findings support using Ultra Seal XT Plus as a reliable method to protect children's teeth from cavities. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8060934/

A Single-blind Randomized Clinical Trial Fifty-nine percent of retention rate was seen with Clinpro compared to Ultraseal XT Hydro sealant (27.27%). Caries incidence was higher in the case of group II.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06342258

NCT06342258 | COES: Curing Order Effects on Sealants The left side of the mouth will have bond and sealant cured together after. Intervention/Treatment, Drug : Ultradent Ultra Seal XT Plus. Each child ...

3. ultradent.com ultradent.com/products/categories/composites/sealants/ultraseal-xt-plus?srsltid=AfmBOorHkGq9pFT0FCh2N0kc6pjZkBpx9DZva79q7as2hnk9LgPpK5Te

UltraSeal XT™ plus-Hydrophobic Pit and Fissure Sealant UltraSeal XT plus hydrophobic pit and fissure sealant is a light-cured, radiopaque, fluoride-releasing composite sealant. It is strong and wear resistant.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8359893/

Microleakage Assessment of Two Different Pit and Fissure ... The study found that the hydrophilic sealant (UltraSeal XT Hydro) had less microleakage than the conventional sealant (Clinpro), with a mean score of 0.60 vs 1 ...

5. withpower.com withpower.com/trial/phase-1-dental-sealant-1-2024-266bb

Dental Sealants for Pediatric Patients (COES Trial) 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% ...

6. ultradent.com ultradent.com/products/categories/composites/sealants/ultraseal-xt-plus?srsltid=AfmBOoptdahAd-cdzzsw2ccQZGy02HoRGiDvmlwwDQqHhdFFdm5w0Q9y

UltraSeal XT™ plus-Hydrophobic Pit and Fissure Sealant UltraSeal XT plus hydrophobic pit and fissure sealant is a light-cured, radiopaque, fluoride-releasing composite sealant. It is strong and wear resistant.

7. optident.co.uk optident.co.uk/app/uploads/2018/03/UltraSeal-XT%C2%AE-plus-SDS-English.pdf

Ultraseal XT Plus Safety Data Sheet Precautionary statements. P101. If medical advice is needed, have product container or label at hand. P102. Keep out of reach of children. P103.

8. henryschein.co.nz henryschein.co.nz/documents/msds/LIVE/Ultradent/UltraSeal%20XT%20Plus_SDS_EXP_20280728.pdf

Material Safety Data Sheet Cover- ... Hazardous decomposition products: No dangerous decomposition products known. 11 Toxicological Information. · Information on toxicological effects. · Acute ...

9. ultradent.lat ultradent.lat/Resources/GetSds?key=25-001-17.95541794-en-gb

UltraSeal XT™ plus Toxicity. · Aquatic toxicity: 109-16-0 Triethylene Glycol Dimethacrylate. EC50. >100 mg/kg (Algae). Biodegradability. 28 days (Aerobic) (Biodegradability ...

10. ultradent.com ultradent.com/Resources/GetSds?key=25-001-17.95505432-en-us&srsltid=AfmBOoqJ7V2RuZdXpsJbjx9hNh7CmGvtBV_u2WNw_9L1Sarmthp4q2Rz

UltraSeal XT™ plus · Application of the substance / the mixture Professional Dental Pit and Fissure Sealant. · Details of the supplier of the safety data sheet. · ...