Dental CariesNCT07052526
Comparative Evaluation of Hydrophilic and Hydrophobic Sealants in Partially Erupted First Molars
A study testing Prevention, Prevention of caries and Prevention therapy in people with Dental Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial aims to evaluate and compare the retention, caries prevention, microleakage, and fluoride release of three types of pit and fissure sealants-hydrophilic, nanofilled hydrophobic, and conventional hydrophobic-applied to partially erupted first permanent molars in children aged 5… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Prevention, Prevention of caries and Prevention therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 1 Apr 2027
- Phase
- Interventional
- 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 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative children (Frankl Scale 3)
- good oral hygiene (OHI-S Index),
- 2 partially erupted 1st molars
Who cannot join
- Cavitated caries
- fluorosis
- hypoplasia
- restored teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Hydrophilic and Hydrophobic Sealants' Retention, Caries Prevention, Microleakage, and Fluoride Release in Partially Erupted First Permanent Molars:A Randomized Controlled Clinical Trial
This randomized controlled clinical trial aims to evaluate and compare the retention, caries prevention, microleakage, and fluoride release of three types of pit and fissure sealants-hydrophilic, nanofilled hydrophobic, and conventional hydrophobic-applied to partially erupted first permanent molars in children aged 5 to 7 years. The study uses a split-mouth design and includes both clinical and laboratory evaluations over an 18-month period. Outcomes will assess sealant effectiveness with and without the use of a bonding agent.
Read the detailed description
This is a randomized controlled clinical trial designed to evaluate and compare the effectiveness of three types of pit and fissure sealants-hydrophilic (Embrace WetBond), nanofilled hydrophobic (DENU Seal), and conventional hydrophobic (Helioseal F)-when applied to partially erupted first permanent molars in children aged 5 to 7 years. The study aims to assess the sealants' clinical retention, their ability to prevent dental caries, microleakage, sealant penetration depth, and fluoride release.
A total of 150 children will be randomly assigned to three equal groups of 50 participants each. A split-mouth design will be used: in each group, sealants will be applied with and without bonding agents on opposite sides of the upper or lower arch, allowing intra-subject comparisons. Clinical evaluations will be conducted at 3, 6, 12, and 18 months to assess sealant retention and caries incidence using the modified Color, Coverage, Caries (CCC) Sealant Evaluation System.
In addition to the clinical phase, a laboratory phase will be conducted using extracted human premolars. This phase will evaluate microleakage and sealant penetration under a stereomicroscope following dye penetration techniques. Fluoride release will be measured at specified time intervals (1, 7, 14, 21, and 28 days) using an ion-selective electrode in artificial saliva conditions maintained at 37°C.
The primary outcomes include sealant retention and caries incidence. Secondary outcomes focus on the degree of microleakage, sealant penetration, and fluoride release. The trial will help determine whether moisture-tolerant sealants offer superior clinical and preventive benefits over traditional hydrophobic materials, particularly in situations where ideal isolation is difficult, such as with partially erupted teeth in young children.
The study will be conducted at the Pediatric Dentistry Clinic, Faculty of Dentistry, Mansoura University, and is expected to generate evidence that could improve clinical decision-making in preventive pediatric dentistry.
- Conditions
- Dental Caries
- Being tested
- Prevention, Prevention of caries, Prevention therapy
- Keywords
- Hydrophilic sealant;, Fluoride, Microleakage, Caries, Retention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreventionOther
Also called Helioseal-F plus
Conventional Hydrophobic Sealant (Helioseal F - Control) will be used as a positive control; applied to partially erupted molars with and without bonding in a split-mouth design.
Prevention of cariesOther
Also called Hydrophilic Embrace-Wetbond
Embrace WetBond sealant will be applied to partially erupted first permanent molars using a split-mouth design with and without bonding agent.
Prevention therapyOther
Also called Denuseal
DENU Seal applied using a split-mouth design to evaluate bonding and non-bonding application outcomes from retention and caries prevention
| Study group | Role | What they receive |
|---|---|---|
| Helioseal Fplus | Experimental | Participants in this arm will receive the Helioseal F Plus resin-based sealant, applied to occlusal surfaces of permanent molars. The sealant will be applied according to the manufacturer's Receives: Other: Prevention |
| 1 - Hydrophilic Sealant (Embrace WetBond) | Experimental | Participants will receive Embrace WetBond sealant, a moisture-tolerant resin sealant applied to slightly moist occlusal surfaces. The sealant is light-cured for 20 seconds Receives: Other: Prevention of caries |
| Denu seal | Experimental | Participants in this arm will receive Denuseal, a fluoride-releasing sealant, applied to occlusal surfaces of permanent molars under dry conditions. The sealant will be light-cured for 20 seconds. Receives: Other: Prevention therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
retention is evaluated using CCC Index (Color, Coverage, and Caries)
This scale is used to assess sealant retention and caries status during follow-up evaluations.
Score Description Retention Caries Status Interpretation
0 Sealant completely retained no caries Full retention Best outcome
- Partial sealant loss no caries Partial loss Acceptable
- Sealant completely lost no caries Total loss Less ideal
- Sealant partially or totally lost caries present Partial or total loss Worst outcome
Measured: 18 months
Caries
Caries Incidence: 3, 6, 12, 18 months, t each recall (3, 6, 12 months), evaluate each sealed tooth using the CCC score:
If the sealant is completely intact and no caries is visible → score = 0
If the sealant is partially gone but no decay → score = 1
If sealant is lost but still no decay → score = 2
If sealant is lost/partial and there is decay → score = 3
Measured: 18 months
Secondary outcomes (2)
Microleakage
Microleakage Assessment (lab) - dye penetration . Score Description Microleakage Depth Interpretation
0 No dye penetration 0% of fissure depth Best outcome
- Dye penetrates into enamel only <50% of enamel Good
- Dye penetrates to dentino-enamel junction (DEJ) Reaches DEJ, no dentin Borderline
- Dye penetrates into dentin Past DEJ into dentin Worst outcome
Minimum score: 0 = no leakage
Maximum score: 3 = extensive leakage
Higher score = worse outcome
Measured: 3 months
Fluoride release
Fluoride Release - spectrophotometer (1, 7, 14, 21, 28 days) Fluoride Release Scoring System (Modified Scale for Clinical Correlation)
Because fluoride release is continuous and measured in ppm or µg/cm²/day, we can categorize release levels into scores for easier interpretation.
Score Fluoride Release Level Typical Range Interpretation
0 High, sustained release >2 ppm after 1 week Best outcome
- Moderate release 1-2 ppm after 1 week Good
- Low release 0.5-1 ppm after 1 week Weak effect
- Negligible release <0.5 ppm after 1 week Ineffective
Measured: 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 150 children aged 5-7 will be randomly assigned to three equal groups of 50 participants each
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed, Mansoura University
- Investigators
- Dr rabaa MAHMOUD ABOU Bakr, Professor, Principal investigator, Mansoura University - Pediatric Dentistry Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052526
- Sponsor's protocol ID
- MU-DPH-Heba2025
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon request for academic use.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hydrophilic and Hydrophobic Sealants' Retention, Caries Prevention, Microleakage, and Fluoride Release in Partially Erupted First Permanent Molars:A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07052526
- Acronym / sponsor ID
- MU-DPH-Heba2025
- Conditions
- Dental Caries
- Keywords
- Hydrophilic sealant;, Fluoride, Microleakage, Caries, Retention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 4 Jul 2025 (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.
This randomized controlled clinical trial aims to evaluate and compare the retention, caries prevention, microleakage, and fluoride release of three types of pit and fissure sealants-hydrophilic, nanofilled hydrophobic, and conventional hydrophobic-applied to partially erupted first permanent molars in children aged 5 to 7 years. The study uses a split-mouth design and includes both clinical and laboratory evaluations over an 18-month period. Outcomes will assess sealant effectiveness with and without the use of a bonding agent.
Detailed description
This is a randomized controlled clinical trial designed to evaluate and compare the effectiveness of three types of pit and fissure sealants-hydrophilic (Embrace WetBond), nanofilled hydrophobic (DENU Seal), and conventional hydrophobic (Helioseal F)-when applied to partially erupted first permanent molars in children aged 5 to 7 years. The study aims to assess the sealants' clinical retention, their ability to prevent dental caries, microleakage, sealant penetration depth, and fluoride release.
A total of 150 children will be randomly assigned to three equal groups of 50 participants each. A split-mouth design will be used: in each group, sealants will be applied with and without bonding agents on opposite sides of the upper or lower arch, allowing intra-subject comparisons. Clinical evaluations will be conducted at 3, 6, 12, and 18 months to assess sealant retention and caries incidence using the modified Color, Coverage, Caries (CCC) Sealant Evaluation System.
In addition to the clinical phase, a laboratory phase will be conducted using extracted human premolars. This phase will evaluate microleakage and sealant penetration under a stereomicroscope following dye penetration techniques. Fluoride release will be measured at specified time intervals (1, 7, 14, 21, and 28 days) using an ion-selective electrode in artificial saliva conditions maintained at 37°C.
The primary outcomes include sealant retention and caries incidence. Secondary outcomes focus on the degree of microleakage, sealant penetration, and fluoride release. The trial will help determine whether moisture-tolerant sealants offer superior clinical and preventive benefits over traditional hydrophobic materials, particularly in situations where ideal isolation is difficult, such as with partially erupted teeth in young children.
The study will be conducted at the Pediatric Dentistry Clinic, Faculty of Dentistry, Mansoura University, and is expected to generate evidence that could improve clinical decision-making in preventive pediatric dentistry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A total of 150 children aged 5-7 will be randomly assigned to three equal groups of 50 participants each
| Arm | Type | Receives |
|---|---|---|
| Helioseal Fplus | Experimental | Other: PreventionParticipants in this arm will receive the Helioseal F Plus resin-based sealant, applied to occlusal surfaces of permanent molars. The sealant will be applied according to the manufacturer's |
| 1 - Hydrophilic Sealant (Embrace WetBond) | Experimental | Other: Prevention of cariesParticipants will receive Embrace WetBond sealant, a moisture-tolerant resin sealant applied to slightly moist occlusal surfaces. The sealant is light-cured for 20 seconds |
| Denu seal | Experimental | Other: Prevention therapyParticipants in this arm will receive Denuseal, a fluoride-releasing sealant, applied to occlusal surfaces of permanent molars under dry conditions. The sealant will be light-cured for 20 seconds. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cooperative children (Frankl Scale 3)
- good oral hygiene (OHI-S Index),
- 2 partially erupted 1st molars
Key exclusion criteria (4 listed)
- Cavitated caries
- fluorosis
- hypoplasia
- restored teeth
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 |
|---|---|---|
| PreventionAlso: Helioseal-F plusConventional Hydrophobic Sealant (Helioseal F - Control) will be used as a positive control; applied to partially erupted molars with and without bonding in a split-mouth design. | Other | Helioseal Fplus |
| Prevention of cariesAlso: Hydrophilic Embrace-WetbondEmbrace WetBond sealant will be applied to partially erupted first permanent molars using a split-mouth design with and without bonding agent. | Other | 1 - Hydrophilic Sealant (Embrace WetBond) |
| Prevention therapyAlso: DenusealDENU Seal applied using a split-mouth design to evaluate bonding and non-bonding application outcomes from retention and caries prevention | Other | Denu seal |
Primary outcome
Retention
Time frame: 18 months
retention is evaluated using CCC Index (Color, Coverage, and Caries) This scale is used to assess sealant retention and caries status during follow-up evaluations. Score Description Retention Caries Status Interpretation 0 Sealant completely retained no caries Full retention Best outcome 1. Partial sealant loss no caries Partial loss Acceptable 2. Sealant completely lost no caries Total loss Less ideal 3. Sealant partially or totally lost caries present Partial or total loss Worst outcome
Caries
Time frame: 18 months
Caries Incidence: 3, 6, 12, 18 months, t each recall (3, 6, 12 months), evaluate each sealed tooth using the CCC score: If the sealant is completely intact and no caries is visible → score = 0 If the sealant is partially gone but no decay → score = 1 If sealant is lost but still no decay → score = 2 If sealant is lost/partial and there is decay → score = 3
2 secondary outcomes
Microleakage
Time frame: 3 months
Fluoride release
Time frame: 2months
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 9 Jul 2025.
- This randomized controlled trial compared hydrophilic (UltraSeal XT Hydro) and hydrophobic (Helioseal-F) resin-based sealants in uncooperative childre in aged 6-9 years. Using a split-mouth design, sealants were applied to 49 pairs of molars and assessedLink provided by the sponsor.
- In-vitro studies on pit and fissure sealants often involve measuring fluoride ion release to assess their potential anticariogenic effects. Fluoride release is typically measured using a fluoride ion-selective electrode and an ion analyzer. Different typLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon request for academic use.
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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.
Dr rabaa MAHMOUD ABOU Bakr, Professor principal investigator
Mansoura University - Pediatric Dentistry Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention, Prevention of caries and Prevention therapy in people with Dental Caries, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Jul 2025. 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 Egypt. 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.
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 Dr. Heba Mohamed DEGHID, Master (2001016684174, Heba.pl70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 18 months). The study lists 2 primary outcomes in all. 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 9 Jul 2025.