Dental SealantPhase 1COESNCT06342258
COES: Curing Order Effects on Sealants
A Phase 1 study testing Ultradent Ultra Seal XT Plus in people with Dental Sealant and Sealant Retention, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Sealant, Sealant Retention
- What is being tested?
- Ultradent Ultra Seal XT Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2024to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Herman Ostrow School of Dentistry of USC
Los Angeles, California, 90089
Catherine Pham, DDS, MPH, 2137400412, cmpham@usc.edu
About this study
Official title: Effects of Cured Bond On Sealant Retention In The Pediatric Population
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.
Read the 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.
- Conditions
- Dental Sealant, Sealant Retention
- Being tested
- Ultradent Ultra Seal XT Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultradent Ultra Seal XT PlusDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Heads | Experimental | 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. Receives: Drug: Ultradent Ultra Seal XT Plus |
| Tails | Experimental | 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. Receives: Drug: Ultradent Ultra Seal XT Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant Longevity
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.
Measured: 2 years
Secondary outcomes (2)
Caries
Secondary objectives of this study aim to look at caries incidence of sealed permanent molars, by monitoring recurrent caries under sealant placement.
Measured: 2 years
Molar hypomineralization
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start23 Feb 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental SealantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After baseline examination, a randomized generator, will be used in order to issue which side will bonding agent cured prior to sealant placement. Randomization will be a simple randomization, and will be determined by the provider flipping a coin. Randomization will be performed to ensure graders of sealants will be blinded to which side of bond is cured prior to sealant placement. 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 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 217 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Pham, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342258
- Sponsor's protocol ID
- HS-23-00611
- Acronym
- COES
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cured Bond On Sealant Retention In The Pediatric Population
- ClinicalTrials.gov ID
- NCT06342258
- Acronym / sponsor ID
- COES / HS-23-00611
- Conditions
- Dental Sealant, Sealant Retention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 217 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After baseline examination, a randomized generator, will be used in order to issue which side will bonding agent cured prior to sealant placement. Randomization will be a simple randomization, and will be determined by the provider flipping a coin. Randomization will be performed to ensure graders of sealants will be blinded to which side of bond is cured prior to sealant placement. 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 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.
| Arm | Type | Receives |
|---|---|---|
| Heads | Experimental | Drug: Ultradent Ultra Seal XT PlusHeads 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 | Experimental | Drug: Ultradent Ultra Seal XT PlusTails 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. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultradent Ultra Seal XT PlusEach 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. | Drug | Heads, Tails |
Primary outcome
Sealant Longevity
Time frame: 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.
2 secondary outcomes
Caries
Time frame: 2 years
Molar hypomineralization
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ultradent Ultra Seal XT Plus in people with Dental Sealant and Sealant Retention, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Pham, DDS (2137400412, cathph@ostrow.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sealant Longevity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.